CRA Handbook

CERTI
FI
CATI
ON
HANDBOOK
CERTI
FI
ED CLI
NI
CALRESEARCH ASSOCI
ATE(
CCRA)
CERTI
FI
ED CLI
NI
CALRESEARCH COORDI
NATOR(
CCRC)
CERTI
FI
ED PRI
NCI
PALI
NVESTI
GATOR(
CPI
)
Welcome to the Academy of Clinical Research Professionals Certification

Programs
The Academy of Clinical Research Professionals (the Academy) would like to congratulate you on your decision
to pursue Certification in your chosen field of work. As a professional in clinical research, you deserve to be
recognized and appreciated for what you do, and like most professionals, you want to become better at it. You
look for opportunities for ongoing professional development and practical ways to evaluate your own work that
will help you develop as a professional.
What is Certification?
Certification is a voluntary process to recognize individuals for meeting professional standards set by an
impartial third party. Academy Certification is the formal recognition of clinical research professionals who have
met comprehensive eligibility requirements, agreed to uphold the ACRP/APCR Uniform Code of Ethics,
demonstrated proficiency of specific knowledge and jobrelated skills by passing a rigorous, standardized exam,
and continuing to maintain their certification through a range of ongoing professional development activities.
Three Certifications are offered:
A Clinical Research Associate (CRA) monitors the administration and progress of a clinical trial on
behalf of a sponsor. A CRA must be independent of the investigative staff conducting the research at the site or
institution. The Certified Clinical Research Associate (CCRA) credential is awarded to a CRA who has met all
eligibility criteria which demonstrate experience with the Essential Duties of a CCRA and passed the
comprehensive ACRP CRA Certification exam.
A Clinical Research Coordinator (CRC) is a professional who, regardless of job title, works at a
clinical research site directly with study subjects under the immediate direction of a principal investigator whose
research activities are conducted under Good Clinical Practice Guidelines. The Certified Clinical Research
Coordinator (CCRC) credential is awarded to a CRC who has met all eligibility criteria which demonstrate
experience with the Essential Duties of a CCRC and passed the comprehensive ACRP CRC Certification exam.
A Principal Investigator (PI) holds a doctorate level degree and serves as the primary, sub-, or coinvestigator on a clinical trial. A PI can also monitor, supervise, or design trials. A PI accepts responsibility for the
safe and ethical conduct of a clinical trial. The Certified Principal Investigator (CPI) credential is awarded to a PI
who has met all eligibility criteria which demonstrate experience with the Essential Duties of a CPI and passed
the comprehensive ACRP PI Certification exam.
ACRP holds its Certification programs to the highest standards, as established by the National Commission for
Certifying Agencies (NCCA). The CCRC, CCRA, and CPI programs are the only clinical research certification
programs accredited by the NCCA, meaning they meet the highest standards for development, administration,
and governance of certification and testing programs. NCCA accreditation assures the validity and credibility of
the Certification process. For more information on the NCCA, visit www.credentialingexcellence.org.
About the Academy of Clinical Research Professionals

Over 30,000 clinical research professionals have become certified through the Academy of Clinical Research
Professionals since the first exams were offered in 1992 with the advent of the CCRC Exam. The CCRA exams
were first offered in 1995, while the CPI Exams were first offered in 2002. The need for ongoing support and
formal governance led to the establishment of the Academy of Clinical Research Professionals (the Academy).
Founded in 2006 as an affiliate of the Association of Clinical Research Professionals (ACRP), the Academy is the
certifying body responsible for the governance and administration of the only job rolespecific, accredited
credentials available to clinical research professionals.
The Academys Board of Trustees, elected by current certificants in good standing, is responsible for awarding
the Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), and Certified
Principal Investigator (CPI) credentials and for establishing eligibility criteria, examination content, passing
scores, and Maintenance of Certification requirements.
The programs are open to any eligible clinical research professional, regardless of membership affiliation. Each
program consists of an assessment of an eligible candidates professional experience and mastery of job-specific
clinical research principles and techniques, as measured by meeting comprehensive eligibility requirements,
successfully passing a rigorous written examination and periodic demonstration of continued competence
through the Maintenance of Certification process.
The Academy adheres to the highest standards by benchmarking its practices against standards set for
certification programs. The National Commission for Certifying Agencies (NCCA) of the National Organization for
Competency Assurance (NOCA) has established criteria for certification agencies. All three of the Academys
programs are NCCA accredited.
As of January 2014, TransCelerate Biopharma, Inc. now recognizes certification through the Certified Clinical
Research Associate (CCRA), the Certified Clinical Research Coordinator (CCRC), and Certified Principal
Investigator (CPI) programs as evidence of Good Clinical Practice (GCP) training.
This exciting development means that TransCelerates membership of pharmaceutical and biotechnology
companies, including 19 major firms working together to create efficiencies within the clinical trials process, will
save time and resources by not requiring CCRAs, CCRCs and CPIs involved in their trials to complete redundant
GCP training for each and every new study team they join.
Table of Contents
Welcome to the Academy of Clinical Research Professionals Certification Programs ........................................................1
What is Certification? ................................................................................................................................................1
About the Academy of Clinical Research Professionals ........................................................................................2
Quick Reference Questions ...........................................................................................................................................5
What is Required for Certification? ................................................................................................................................7
Eligibility Requirements of Certification .........................................................................................................................7
Clinical Research Coordinator (CCRC) Program ...............................................................................................................8
CCRC Eligibility Requirements .....................................................................................................................................8
CCRC Essential Duties ................................................................................................................................................8
Clinical Research Associate (CCRA) Program ................................................................................................................ 10
CCRA Eligibility Requirements .................................................................................................................................. 10
CRA Essential Duties ............................................................................................................................................... 11
Principal Investigator (CPI) Program ........................................................................................................................... 12
CPI Eligibility Requirements ..................................................................................................................................... 12
PI Essential Duties .................................................................................................................................................. 13
Clinical Research Education Programs- Substitution for ............................................................................................... 14
Work Experience Requirements ................................................................................................................................. 14
Application for Certification ................................................................................................................................. 15
Completing the Application Form ............................................................................................................................. 15
Supporting Documents ........................................................................................................................................... 16
Application and Exam Fees ...................................................................................................................................... 17
Submitting the Application ...................................................................................................................................... 18
Receipt of Application ............................................................................................................................................. 19
Application Checklist............................................................................................................................................... 19
Transfer Application to Next Exam Window .............................................................................................................. 20
Refunds and Cancellation of Application................................................................................................................... 21
Eligibility Review ....................................................................................................................................................... 21
Confirmation of Eligibility ........................................................................................................................................ 21
Ineligibility Decision Appeals Process ....................................................................................................................... 22
Exam Scheduling ................................................................................................................................................... 23

Exam Appointment Scheduling ................................................................................................................................ 23
Services for People with Disabilities ......................................................................................................................... 24
Rescheduling or Canceling an Exam Appointment ..................................................................................................... 24
Emergencies .......................................................................................................................................................... 25
Exam Format .......................................................................................................................................................... 26
Exam Structure and Delivery ............................................................................................................................... 26
Language ............................................................................................................................................................. 26
Exam Content and Preparation ............................................................................................................................ 27
What is Covered on the Exam? ........................................................................................................................... 27
What is Covered on the Exam? ............................................................................................................................ 28
Detailed Content Outline ..................................................................................................................................... 28
Study Texts ............................................................................................................................................................ 28
Certification Exam Abbreviation List......................................................................................................................... 29
Steps to Preparing for the Exam ......................................................................................................................... 30
ACRP Online Preparation Support ............................................................................................................................ 31
Further Study Tips .................................................................................................................................................. 31
Taking the Exam ........................................................................................................................................................ 32
Exam Appointment Arrival ...................................................................................................................................... 32
Required Identification............................................................................................................................................ 33
Exam Security and Test Center Guidelines................................................................................................................. 33
Resources Available at the Test Center ..................................................................................................................... 34
Test-Taking Strategies ............................................................................................................................................ 34
Exam Results .......................................................................................................................................................... 34
Duplicate Certificates ................................................................................................................................................. 35
Exam Scores .............................................................................................................................................................. 35
Scaled Scores and Score-Reporting FAQs .................................................................................................................. 36
How Are Certification Exams Developed? ................................................................................................................... 37
Maintenance of Certification ...................................................................................................................................... 39
Maintenance Requirements .................................................................................................................................... 39
Frequently Asked Questions (FAQs) ............................................................................................................................ 40
Appendix................................................................................................................................................................... 42
The Academy Certification Policy Manual ................................................................................................................. 42

Detailed Content Outline (DCO) for Certified Clinical Research Coordinator ................................................................. 42
Detailed Content Outline (DCO) for the Clinical Research Associate Exam ................................................................... 48
Detailed Content Outline (DCO) for the Certified Principal Investigator ....................................................................... 53
Quick Reference Questions
Refer to the following table for some common points of contact throughout the Certification process.
Question or Concern
Contact Whom?
Exam Registration
Contact Information
Was my Exam application received?
The Academy
I didnt receive notification of eligibility.
The Academy
certification@acrpnet.org
The Academy
Prometric website
www.prometric.com/ACRP
What is my Prometric testing ID number?

How can I locate a test site?
Can I reschedule my appointment more
than 29 days prior to exam?
Yes, contact Prometric;

No fee
Can I reschedule my appointment from

16 to 29 days prior to exam?

$25 fee
Can I reschedule my appointment from 5

to 15 days prior to exam?

$50 fee
Call 800.853.6769
OR
No. Rescheduling is not

permitted less than 5 days prior
to exam date. All fees are
nonrefundable.*
*Rescheduling needs due to emergency- view Exam Scheduling/ Emergencies section ; submit Emergency
Exam Cancellation Form to the Academy
*For emergencies, contact certification@acrpnet.org; see
Can I reschedule my appointment from 4

to 0 days prior to exam?
Exam Transfers/Cancellations
Can I transfer/cancel my application
more than 29 days prior to scheduled
exam?
Can I transfer/cancel my application

from 16 to 29 days prior to scheduled
exam?
*Yes. First, contact Prometric to

cancel appointment. Next, notify
the Academy via e-mail.
Prometric: 800.853.6769
AND

cancel appointment and pay $25
change fee. Next, notify the
Academy via e-mail.
E-mail the Academy:

(Include Exam Transfer
Request Form if transferring)
Can I transfer/cancel my application from

5 to 15 days prior to scheduled exam?

cancel appointment and pay $50
change fee. Next, notify the
Academy via e-mail.
*Transferring all fees is
acceptable through the last day
the exam is being offered.
Cancelling is not permitted

however, less than 5 days from
the last day the exam is being
offered. All fees are
nonrefundable.
*No. When an exam appointment
For emergencies, contact
Can I transfer/cancel my application from is scheduled, transferring or
certification@acrpnet.org; see
4 to 0 days prior to scheduled exam?
canceling is not permitted less
Exam Scheduling/
than 5 days prior to an exam
Emergencies section
date. All fees are nonrefundable.
*Note: Transferring is a one-time only option. Current transfer candidates cannot transfer again or cancel for a
refund. Cancellation needs due to emergency- view Exam Scheduling/ Emergencies section ; submit
Emergency Exam Cancellation Form to the Academy
I did NOT schedule an exam
appointment? When is the last day I can
transfer my fees to the next exam period
or cancel my application for a refund?
Post Exam Questions

Change of contact information
When can I expect confirmation of my
exam results?
The Academy
Exam results are offered at the
test center, immediately
following completion of exam.
Official confirmation of these
results will be emailed and
mailed as early as two weeks
after exams close. Allow four
weeks to receive mail outside of
the US.
General Contact Information

Prometric Member Services
To report issues with your Prometric
experience
The Academy
Prometric
800.481.6525
Prometric
800.853.6769
Certification Program
Phone: 703.254.8106
STEP 1:
STEP 2:
Meet Eligibility
Requirements
Apply for Eligibility

Review and Exam
STEP 3:
Pass Exam
What is Required for Certification?

In order to achieve certification, all applicants must meet the Eligibility Requirements and pass an Exam.
The purpose of the ACRP Certification Handbook is to provide detailed information for becoming ACRP
Certified, specifically, the eligibility requirements, applying, eligibility review, scheduling an exam, exam
preparation, and understanding exam results. All of the requirements are provided in this all-encompassing
document, with links to important forms, policies and webpages. Please contact us at certification@acrpnet.org
with any questions not answered here.
The applicant should determine his/her own eligibility before submitting an application to the program. Upon
submission of a complete application, an eligibility review is conducted by the Academy. The candidate is then
notified of the eligibility review outcome via e-mail. All eligible candidates must then schedule an appointment
to take the exam.
Candidates who meet the eligibility requirements and pass the exam for the CCRA, CCRC, or CPI program will be
certified as having met the Academy standards for becoming a CCRA, CCRC, or CPI respectively, as adopted by
the Academy. Maintenance of Certification of ones certification is required every two (2) years for continuance
of the designation.
Each ACRP Certification program has a unique set of eligibility requirements, detailed in the next section.
Eligibility Requirements of Certification

For each of the three ACRP Certification programs, there are eligibility requirements which must be met prior to
applying for a program. The requirements are based on role-specific employment experience over a specified
number of hours/ years. This employment experience required by the Academy for eligibility is consistent with
the criteria used by other specialty certification boards in healthcare. The Academy believes that recent
experience in clinical research is a major source of knowledge and skills, as well as gaining an understanding of
how to apply those. The content and practice of clinical research is largely learned by doing, given that there are
a limited number of educational programs and that the clinical research professional develops specialized
knowledge and skills through practice.
Clinical Research Coordinator (CCRC) Program

A clinical research coordinator (CRC), regardless of job title, works at a clinical research site directly with study
participants and works under the immediate direction of a principal investigator, whose research activities are
conducted under Good Clinical Practice (GCP) guidelines.
The CCRC credential is awarded to a CRC who has met comprehensive eligibility requirements, agreed to uphold
the ACRP/ACRP Uniform Code of Ethics, passed a rigorous, standardized ACRP CRC Certification exam, and
agreed to continue to maintain certification through participation in ongoing professional development
activities.
CCRC Eligibility Requirements

In order to be deemed Eligible to take the CRC Certification exam, applicants for the CCRC credential must be
able to provide evidence through a job description, detailed CV or other documentation that they:
Perform EACH of the CCRC Essential Duties as detailed below for a required minimum number of hours.
Hours performing the CCRC Essential Duties can include hours documented up to the date of the exam
and/or through previous employment. The required number of hours is dependent upon ones
educational background.
CCRC Essential Duties

As defined by the Academy, and determined through ACRPs 2010 Job Analysis Survey, clinical research
coordinators who are eligible for CRC Certification must document cumulative performance of each of the
following Essential Duties during the dates of employment listed on the application:
Document adverse events;

Prepare or review documents submitted to the institutional review board (IRB);
Protocol review or study procedures planning;
Participate in conducting subject visits;
Maintain source documents;
Prepare for and participate in study visits with monitor, sponsor, auditors, etc.;
Participate in consent process.
CCRC Eligibility Requirements
At least one of the Eligibility Requirement options below should be met before applying for the CCRC program.
Education
Option 1
Option 2
Associates or Bachelors degree

(or higher)
or
Registered Nurse (RN)
Other, such as LPN, LVN, Medical
Assistant, Lab Technician
or
High School diploma
Minimum Hours
Performing
Essential Duties
3,000 hours*
4,500 hours*
Required Documentation of
Performed Essential Duties
Detailed CV/Rsum
and
Job Description
Detailed CV/Rsum
and
Job Description
*see section for the option of substituting Clinical Research Education Programs for work experience
Clinical Research Associate (CCRA) Program

A clinical research associate (CRA), regardless of job title, supervises, monitors, and supports the administration
and progress of a clinical trial on behalf of a sponsor. The sponsor, whose intent is the research of
pharmaceuticals, biologics, or devices, may employ these individuals either directly or indirectly via contract
research organizations (CROs), or as independent consultants or contractors.
The CCRA credential is awarded to a CRA who has met comprehensive eligibility requirements, agreed to uphold
the ACRP/ACRP Uniform Code of Ethics, passed a rigorous, standardized ACRP CRA Certification exam, and
agreed to continue to maintain certification through participation in ongoing professional development
activities.
CCRA Eligibility Requirements
In order to be deemed Eligible to take the CRA Certification exam, applicants for the CCRA credential must be
able to provide evidence through a job description, detailed CV or other documentation that they:
Work independently of the investigative staff conducting the research at the site or institution. This
means they do not report to the PI or site manager and that they do not have the ability to change or
manipulate data, AND;
Work on behalf of the sponsor. This means that they are contracted by the sponsor to perform an
independent monitoring function. The sponsor can be a pharmaceutical or device company, a
government or granting agency, a university department, a physician, etc., AND;
Perform EACH of the CRA Essential Duties as detailed below for a required minimum number of hours.
Hours performing the CRA Essential Duties can include hours documented up to the date of the exam
and/or through previous employment. The required number of hours is dependent upon ones
educational background.
10
CRA Essential Duties
As defined by the Academy, and determined through ACRPs 2010 Job Analysis Survey, clinical research
associates who are eligible for CRA Certification must document cumulative performance of each of the
following Essential Duties during the dates of employment listed on the application:
Verify that the research site personnel, including the investigators, are conducting the study according
to the clinical protocol, Good Clinical Practices, and regulatory requirements;
Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC;
Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents
(source data verification);
Review accuracy and completeness of site records (site study file, query resolution, and other data
collection tools);
Verify Investigational Product accountability;
Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial
management tracking system);
Conduct routine monitoring visits on behalf of the clinical trial sponsor.
CCRA Eligibility Requirements

At least one of the Eligibility Requirement options below should be met before applying for the CCRA program.
Education
Bachelors degree (or higher)

OR
Registered Nurse (RN)
Associates degree
Option 1
Option 2
Minimum Hours
Performing
Essential Duties
3,000 hours*
4,500 hours*
Required Documentation
of Performed
Essential Duties
Detailed CV/rsum
and
Job Description
Detailed CV/Rsum
and
Job Description
Other, such as LPN, LVN, Medical

Detailed CV/Rsum
Assistant, Lab Technician
6,000 hours*
and
Option 3
OR
Job Description
High School diploma
*see section for the option of substituting Clinical Research Education Programs for work experience
11
Principal Investigator (CPI) Program

A Principal Investigator (PI) holds a doctoral-level degree (PhD, PharmD, DNP, DO, MD, MBBS, DDS, etc.) and
serves as the primary, sub-, or co-investigator on a clinical trial. A PI can also monitor, supervise, or design trials.
A PI accepts responsibility for the safe and ethical conduct of a clinical trial.
The CPI credential is awarded to a PI who has met comprehensive eligibility requirements, agreed to uphold the
ACRP/ACRP Uniform Code of Ethics, passed a rigorous, standardized ACRP CPI Certification exam, and agreed to
continue to maintain certification through participation in ongoing professional development activities.
2015 Update: The March 2015 CPI Exam is the first exam being offered to all investigators with a doctoral-level
degree. A license to practice medicine is no longer required.
CPI Eligibility Requirements
In order to be deemed Eligible to take the PI Certification exam, applicants for the CPI credential must be able to
provide evidence through a job description, detailed CV or other documentation that they:
Have proof of employment as a PI during at least two (2) of the most recent five (5) years AND;
Perform all of the Essential Duties as detailed below. These Essential Duties were defined by the 2010
ACRP Job Analysis specifically for the PI job role AND;
Holds a doctoral level degree (PhD, PharmD, DNP, DO, MD, MBBS, DDS, etc.)
Employment
Employment is broadly defined as paid services, fellowships and internships. Employment experience must
include service as a primary, sub- or co-investigator or a medical monitor, supervisor or designer of one or more
clinical trials during at least two (2) of the most recent five (5) years. Documentation that supports this role and
employment must include the applicants name and be signed and dated. A least one form of acceptable
documentation will need to be provided for EACH of the two (2) years within the most recent five (5) years
supporting employment as a PI during that time.
Completion of an applicable clinical research education program can be substituted for one (1) of the required
one (1) year periods of employment. See section below for for the option of substituting Clinical Research
Education Programs for work experience
Applicants must submit a detailed rsum or CV (see Appendix 1 for sample CV) and a job description with the
exam application. This must include a description of the candidates PI job functions and specific employment
dates. Do not include a list of study participation with your CV.
12
PI Essential Duties
As defined by the Academy, and determined through ACRPs 2010 Job Analysis Survey, principal investigators
who are eligible for PI Certification must document performance of the essential PI duties using a Job
Description for each relevant position held during the dates of employment listed on the application. The
Essential PI Duties are as follows:
Responsible for the safe and ethical conduct of a clinical trial;

Evaluates the study proposal and decides on participation;
Facilitates or verifies formal approvals according to regulatory requirements and International
Conference on Harmonisation (ICH) Good Clinical Practice (GCP);
Ensures that all site initiation activities are performed to start and conduct the study;
Participates in the selection of trial subjects according to the recruitment strategy;
Performs or supervises the conduct of study-related procedures and monitors the safety of the trial
subjects and investigational staff;
Collects accurate and verifiable data and other essential study documents;
Ensures compliance with regulatory requirements and ICH GCP, the protocol and the handling of the
investigational product;
Communicates with subjects, sponsors personnel, and Institutional Review Board
Ensures adequate close-out of the study
CPI Eligibility Requirements
Documentation to be submitted
Requirements
Education
Doctorate level degree (DDS, MD, DO, MBBS or MBChB, PhD, PharmD, DNP,
licensed Physicians Assistant, etc.
CV must reflect name of educational institution, location (city, country), title of
degree and date awarded.
Experience
For at least TWO (2) of the most recent five (5) years*:
1572 / PHS 398 / QIU (or equivalent) OR
IRB/IEC approval letter to conduct the study OR
Protocol approval letter for the study OR
Notarized statement from a Program Director indicating your role as the principal
or sub investigator, monitor or designer of a trial OR
Signed copy of an investigator agreement/protocol signature page OR
Other regulatory authority document verifying your role as a Principal
Investigator or sub-investigator on the clinical trial being submitted in support of
eligibility
Any proprietary details may be blocked out.
*see section below for the option of substituting Clinical Research Education Programs for work experience
13
Clinical Research Education Programs- Substitution for

Work Experience Requirements
The Academy considers applicants who have completed a clinical research education program that meets the
following standards to have achieved a valid substitute for 1,500 hours of professional experience for the CCRA
or CCRC program, and one (1) of the two (2) required years of employment as a principal investigator, for the
CPI program.
Acceptable programs must:
Be at least 216 contact hours in length (at least 15 semester credits) and;
Cover content that substantially maps to the topics found on the current for the program:
CCRA Detailed Content Outline (DCO)
CCRC Detailed Content Outline (DCO)
CPI Detailed Content Outline (DCO) and;
Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation

(CHEA) or the appropriate authorizing authority in the country in which the institution operations. A list
of recognized US accrediting agencies can be found from the CHEA website: www.chea.org/search.
The Academy provides a list of Academic clinical research programs which have been evaluated and found to
meet the current waiver requirements established by the Academy. Programs that meet the waiver
requirements allow a candidate to waive 1,500 hours of handson experience performing the Essential Duties of
the program to which the candidate has made application. This list is not to be considered exhaustive and is not
designed to represent all the academic offerings. View the Accepted Academic Clinical Research Programs List.
If an applicant submits an application using an educational program as a substitute for 1,500 hours of
CRC/CRA/PI work experience, then the following information must be included on the applicants CV (see
sample CV) and a certificate of completion must also be submitted:
Name of school
City and country in which the school is located
Program title
Name of organization that accredits the institution providing the program
Dates attended (From-To)
View Policy on Denial of Eligibility and Policy on Appeal of Denial of Eligibility
14
Application for Certification

Once an applicant has carefully determined he/she meets the eligibility requirements, the application process
can begin. Applications are submitted online or via a printable method. Early-Bird and Regular application due
dates and fees are available online at http://www.acrpnet.org/applicationandrates.
The following must be uploaded or submitted together by the due date (received, not postmarked) to be
considered for review:
Application Form (CRA, CRC, or PI) AND
2. Supporting documentscurriculum vitae (CV)/ rsum (CPI only- proof of employment) AND
3. Detailed job description AND
4. Full payment
1.
The Application form, all supporting documents, and full payment must be submitted together and by the due
date in order for the candidate to be considered for the next step (the eligibility review to take the written
exam). All documentation must be provided in English. If the original documentation was translated into English,
it must also be submitted in the original language, with the certified translated document.
Completing the Application Form

Access the online or printable Application Form from the ACRP website at
www.acrpnet.org/certificationprograms. Using the online application is recommended, as it is received
immediately for eligibility review. Completed copies are not available, therefore, it is recommended for the
applicant to take a screen shot if one is needed. Have all documentation and employment information ready so
that data in the online application is captured and does not time out.
Applicants submitting a check or bank transfer must submit the printable version of the application with the
check or receipt for bank transfer. If completing the printable application, make sure the application is received
(not postmarked) by the Academy by the Early-Bird or Regular deadline.
15
Have the following information ready before applying:
Work Experience
1. Employer(s) list only positions supporting experience performing the essential functions of a CRC.
2. Supervisor Name
3. Address
4. Phone
5. Supervisor Email
6. Start and End Date of Employment (consistent with CV/rsum)
7. Average Hours Worked per Week (enter an exact number amount, i.e. 45)
The Academy has the right to verify qualifications. By submitting an application, applicants consent to and
authorize the Academy to verify the applicants academic and employment records. The Academy reserves the
right to request backup documentation to substantiate the reported information at any time during the
application process and/or once the candidate has been certified.
Supporting Documents
Supporting documentation is required for the education and work experience listed in the application. A
detailed CV or rsum is required.
Education documentation includes a listing on the CV or rsum with name of educational institutions, location
(city, country), title of any degree(s) with date(s) awarded. For PI applicants only: a doctorate level degree (DDS,
MD or equivalent degree such as DO, MBBS or MBChB, PhD, PharmD or DNP, licensed Physicians Assistant, etc.)
is required.
Work experience documentation includes employers, corresponding employment dates, and a description of
the Essential Duties performed by the applicant. Only positions in which the applicant has performed the
Essential Duties and job functions are considered, regardless of the job title. No other positions or study
participation listings will be considered. See CRC and CRA Sample CV/ Rsum and Job Description.
Job Description(s)
A job description is a required document that further details the tasks performed for each relevant position. It
may be employer- or applicant-created, and should list only the specific functions and tasks performed that
support ones eligibility. See CRC and CRA Sample CV/ Rsum and Job Description.
16
Proof of Employment (Required for CPI Only)
Required Proof of Employment documents must be included to support employment as a PI during at least
TWO (2) of the most recent five (5) years:
Regulatory filings such as 1572 / PHS 398 / QIU (or equivalent) OR
IRB/IEC approval letter to conduct the study OR
Protocol approval letter for the study OR
Notarized statement from a Program Director indicating your role as the principal or sub investigator,
monitor or designer of a trial OR
Signed copy of an investigator agreement/protocol signature page OR
Other regulatory authority document verifying your role as a Principal Investigator or sub-investigator on
the clinical trial being submitted in support of eligibility.
Any proprietary details may be blocked out.
Certificate/Transcript
Candidates who are substituting the completion of a clinical research education program for work experience
are required to provide a Certificate of Completion or transcript. (See Accepted Academic Clinical Research
Programs List)
Application and Exam Fees
The cost to apply includes an Exam and Application fee. Early- Bird pricing applies for anyone applying early
and always applies for ACRP Members throughout the application period. The fees are as follows:
Apply Early
October 1 December 1, 2014
(Early - Bird)*
Application Fee
(non-refundable)
Exam Fee
(refundable)
TOTAL Due at the Time of
Application
Apply
December 2, 2014 February 1,
2015
$125
$200
$325
$325
$450
$525
*ACRP/ APCR Members always pay the Early-Bird rate. Before you apply, log on to www.acrpnet.org to verify
your ACRP or APCR Membership status and confirm the total payment due at time of application.
The $325 Exam fee is refundable should an applicant not be eligible to take the exam or need to cancel within a
reasonable time frame. The application fee is non-refundable regardless of eligibility status or cancellation.
Credit card, check, or bank transfers are acceptable forms of payment.
17
Submitting the Application

Methods of Payment and Delivery
Payment Method
Credit Card
Check or
Bank/Wire Transfer
Application Method
Online
Application
(recommended)
Documents Required to be Submitted WITH Application

1.
2.
3.
4.
CV/rsum
Job description
Proof of employment (CPI only)
Educational program certificate (if using waiver option)
Printable Application
(Mailed or Faxed))
Upload documents as part of application or

Mail documents with printable application
Printable Application
(only via Mail)
1. CV/rsum
2. Job description
3. Proof of Employment (CPI only)
4. Educational program certificate (if using waiver option)
Mail documents with application; include check/ bank
transfer receipt
Only applications received with required supporting documentation and full payment will be processed. Note:
File sizes must be less than five (5) megabytes for online applications.
VERY IMPORTANT: Incomplete applications, or applications submitted without the correct fee, will not be
processed. It is the candidates responsibility to submit all relevant documents and payment at the time of
application, by the due date. All fees must be paid in full by check, bank transfer, or credit card (American
Express, Visa, or MasterCard). Corporate checks must reference each applicants name.
Submission of the application constitutes agreement that the candidate has read, understood, and agrees to
abide by the ACRP/APCR Code of Ethics and Professional Conduct. Applicants are required to sign a disclosure
statement attesting to the accuracy of the information provided as part of the application process. By submitting
an application, the applicant consents to and authorizes the Academy to verify the candidates academic and
employment records.
Application for, and achievement of, Academy Certification is between the Academy and an individual
candidate. Therefore, application details and status, fees, eligibility status, exam appointments, and exam
results are confidential to the individual and cannot be disclosed, regardless of payer. Only the candidate is
permitted to withdraw an application or cancel an exam appointment, regardless of payer.
18
Receipt of Application
An e-mail confirmation of payment is automatically sent once payment is processed. At that point, your
application will enter the Eligibility Review process. Please allow up to 10 days to receive notification regarding
an eligibility decision.
To ensure you receive important Certification-related notifications, add @acrpnet.org to your safe senders list
(contact your IT department for instructions). Please take any necessary steps to prevent filtering of ACRP emails.
If the printable application is submitted, it is highly recommended that the applicant mail it to the Academy via
certified mail, express parcel service, or another traceable courier to ensure receipt by the application receipt
deadline. Keep fax confirmations for tracking purposes, if sending the application via fax.
The following checklist is a resource in taking the appropriate steps to begin the Certification process.
Application Checklist
CCRA, CCRC, and CPI Exams
Applications must be received by February 1, 2015.
Prepare to Apply
Read this Certification Handbook for important application steps, eligibility requirements, exam preparation, and
Certification exam information for which you are responsible for understanding.
Determine your eligibility before you apply. Obtain the correct application (e.g., CRC, CRA, or PI).
Complete the Application
Apply using your full, legal name. The first and last name must match your government issued identification.
Middle names are not considered.
When completing the Statement of Experience section, list all positions for which the Essential Duties were
performed. Dates of employment must match those listed on your CV/rsum.
Include your CV/rsum.
Include a job description with dates of employment for each position listed in the "Statement of Experience"
section to support your eligibility.
Include a program certificate or transcript (for work experience substitution only).
PI Applicants only Include proof of employment documents, (i.e., IRB/IEB approval letter)
Confirm all documentation is in English. If original documentation was translated into English, it must also be
submitted in the original language, with the certified translated document.
Complete all sections completely and accurately.
Sign "Authorization and Agreement" (and "Payment" if paying by credit card) sections.
Submit the Application
Submit the complete application (e.g., application, supporting documentation and full payment) together.
Incomplete submissions will result in a denial of eligibility.
Ensure your application will be received by the due date.
Submit your application online OR via e-mail, fax, or traceable mail (see Payment section for details).
Receive e-mail confirming the date your payment is applied.
19
Transfer Application to Next Exam Window
The Academy offers a one-time transfer from the current exam offering to the next. There are two situations in
which candidates may take advantage of this:
1. If a candidate is determined ineligible for the current exam window, but will have met the eligibility
requirements by the next exam window; or
2. If an eligible candidate withdraws from taking the original exam for any reason (up to five [5] days
before a scheduled exam appointment)
Transfers are applied toward the next exam only. Transfer of eligibility and associated fees will be applied only
to the original candidate and are not transferable to another person, even if paid for by a third party. Exam fees
are transferred toward the next exam only and not toward other products or services.
If you choose to transfer to the next exam window for one of the two reasons above, you must submit a
Request to Transfer Exam Application Form before the end of the exam window for which you had originally
applied.
If you have an exam appointment scheduled, you must first cancel it directly with Prometric (see chart, section
Rescheduling or Canceling an Exam Appointment) before submitting the Request to Transfer Exam Application
Form to ACRP. Fees, payable to Prometric directly, apply for appointment cancellations made within thirty (30) to
five (5) days prior to an appointment date. Cancellations are not permitted less than five (5) days prior to an
appointment.
If a transfer candidate does not submit the request before the end of the current exam testing window, then all
funds originally submitted will be forfeited. Transferring is not an option for re-examination candidates (from
the previous exam cycle).
When a transfer request has been approved, all fees (application and exam fees) are applied automatically at
the start of the next application period. All eligible transfer candidates will receive an email notice of Eligibility
when the Eligibility ID has been reactivated and an exam appointment can be scheduled. Contact
certification@acrpnet.org if you did not receive your new Eligibility notice. Candidates who are required to
submit documentation for subsequent eligibility review must do so at the start of the next application period.
View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination
20
Refunds and Cancellation of Application
Once a candidate submits an application, it cannot be withdrawn. Candidates who wish to discontinue the
Certification process may submit an Application Cancellation Request Form to obtain a refund of the Exam Fee
only. The application fee is non-refundable. If a candidate submits such a request after the candidate has
received an Eligibility ID, the ID number will be invalidated.
The only portion of the total amount submitted that will be refunded is the exam fee, provided that the request
is received at least five (5) calendar days prior to a scheduled exam appointment (if one is scheduled).
Cancellation requests received after that time will not be honored. Refunds are not available to candidates who
do not schedule or attend the exam.
Only the candidate may request a cancellation or refund, regardless of whether the exam fee was paid by the
candidate or another party. Employers supporting a candidates fees cannot request or receive a refund for fees
paid to the Academy. Any refund will be sent to the party who initially paid for the exam. If payment was made
by credit card, that card will receive the credit. If the payment was made by check, the Academy will mail a
refund check to the original payer.
Applicants who do not meet the eligibility requirements for the exam (i.e., those who are ineligible), or who are
ineligible due to an incomplete application, will receive a refund of the exam fee only, within three weeks of the
final ineligibility notification.
View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination.
Eligibility Review
The Eligibility Review process includes determining completeness of the application and determining whether or
not the applicant meets the eligibility criteria for the exam. Applicants should expect to receive an update via
email within seven to ten days after the application has been received.
It is not unusual for an applicant to receive a request for additional and/or clarifying information from an
Eligibility Reviewer. These requests will come via e-mail. Applicants will have seven (7) calendar days to respond
to the request. Applicants who do not respond to the request for additional or clarifying information will
automatically have their applications determined incomplete and therefore are ineligible to take the exam.
Ineligible applicants will be refunded the exam fee ONLY, and will need to re-apply to the program and pay all
fees if they decide to pursue Certification in the future. Incomplete applications will not be returned.
Confirmation of Eligibility
If an applicant is determined to be eligible after the application has been reviewed, the candidate will be emailed an Eligibility Notice, with further instructions as to how to schedule his/her exam appointment. A
candidate must schedule an Exam Appointment or forfeit any fees paid. Exam Appointments can only be
scheduled after eligibility is determined.
If an applicant is determined to be ineligible during initial review, the application is automatically reviewed by a
second reviewer. If the second reviewer also determines the applicant to be ineligible, the application is
21
automatically sent to the Director of Certification for a third review. Applicants are notified via e-mail at each
step of the review with an explanation of the deficiency identified.
If, after the three levels of review, the applicant is still determined to be ineligible, the applicant can choose to
appeal to the Academy Board of Trustees. However, after the third level of review by the Director of
Certification, applicants can no longer submit new documents to overturn an eligibility decision.
Applicants found to be ineligible who do not initiate the Appeals process within the stipulated timeframe will
automatically be refunded the exam fee only, within two (2) weeks.
View the Academys Policy on Appeal of Denial of Eligibility.
Ineligibility Decision Appeals Process
The Academy of Clinical Research Professionals (the Academy) makes every attempt to make fair and accurate
eligibility decisions based on the information provided by the applicants. An appeal procedure is available to any
applicant who has applied for certification by the Academy and who wishes to contest any adverse decision
affecting his or her application for certification status. Any individual who does not file a request for an appeal
within the required time limit shall waive the right to appeal.
Candidates are permitted to appeal a decision made during the review of his/her application for certification.
Candidates are not permitted to appeal:
1. The passing score for the exam, or the process used to establish that passing score, which may result in
failure of the certification examination.
2. Existence of an eligibility requirement. The Policy on the Appeal of Denial of Eligibility provides for
appeal of the interpretation of the eligibility requirements in individual applicants circumstances.
Candidates do have the ability to appeal the content and quality of the examination, as well as questions and
answers. However, candidates may not have access to the test form, their answers, or the answer key. Read the
Academys Policy on Appeal of Denial of Eligibility section, for details.
22
Exam Scheduling
Exam Appointment Scheduling
The Academy offers a 24-day testing window. All candidates who have been determined eligible must schedule
an appointment to take the exam.
Exams are scheduled through Prometric, the Academys testing partner, and may be taken at approximately 600
testing centers internationally. Only candidates determined to be eligible will receive an Eligibility Notice
immediately following the Eligibility Review process. Here is a sample Eligibility Notice:
This important notice includes a Prometric ID number, the Prometric web address, and instructions for
scheduling an exam appointment. The candidate must also verify that the FIRST and LAST name on the Eligibility
Notice (registered with Prometric and ACRP) is identical to the first and last names displayed on the candidates
current, government-issued identification (ID). The ID must also bear a photo and signature to be an acceptable
form of ID. See Taking the Exam section.
Only when the name matches the candidates legal identification, should the candidate schedule an exam
appointment. The testing center, exam date, and time are available on a first-come, first-served basis.
To view testing locations, visit www.prometric.com/acrp at any time. For detailed assistance with selecting your
test center, view www.acrpnet.org/PDF/ExamSites.pdf.
23
Services for People with Disabilities

The Academy is committed to ensuring that no individual with a disability is deprived of the opportunity to take
an exam solely by reason of that disability. The Academy will provide reasonable accommodations for
candidates with disabilities pursuant to the Americans with Disabilities Act (ADA). The following reasonable
accommodations may be addressed:
Wheelchair access is available at all established test centers.

Candidates with visual, sensory, cognitive, or physical disabilities that would prevent them from taking
an exam under standard conditions may request reasonable accommodations and arrangements.
To request a reasonable accommodation, one is required to submit at the time of application:
Submit to the Academy a Special Accommodations Form, signed by a licensed health professional
approving the request as accurate and reasonable. This MUST be submitted at the time of application.
Check the designated box on the exam application.
A link to the Special Accommodations Form is available on the website and also in the online and printable
applications. Submit this form with your application to certification@acrpnet.org. Only reasonable
accommodation will be made during the available exam window.
Rescheduling or Canceling an Exam Appointment
Rescheduling or canceling an exam appointment (test center location, date, or time) is permitted by Prometric
up to five (5) days before your scheduled appointment. There may be fees associated with appointment
changes, as noted in the chart below. Rescheduling availability varies, depending on the test center location,
and number of days prior to the exam appointment date.
To reschedule or cancel an exam appointment, you must contact Prometric directly at 800.853.6769 or
www.prometric.com/ACRP with your appointment confirmation number.
If you do not plan to take the exam during the current exam window, you must FIRST, cancel your exam
appointment and SECOND, submit one of the following requests:
1. Application Cancellation Request (for cancelling the application and requesting a refund only); submit
up to 5 days before scheduled appointment. Refer to the Refunds and Cancellation of Application
section.
OR
2. Request to Transfer Exam Application Form (for transferring your application to the next exam window
only); submit by last possible exam date. Refer to the Transfer to Next Exam Window section.
Your request must be received by the Academy at certification@acrpnet.org within the time specified or all fees
paid will be forfeited.
24
Exam Appointment Rescheduling / Cancellation

Contact Prometric directly at 800.853.6769 or online at www.prometric.com/ACRP.
Time Before Appointment

More than 30 days before
scheduled appointment
Prometric Fees
No charge
29 to 16 days before scheduled

appointment
$25
15 to 5 days before scheduled

appointment
$50
Less than 5 days before

scheduled appointment
Method
Online or via phone
Online or via phone
Online or via phone
Not permitted All fees

forfeited
Cancellations due to emergency
See policy below
Failure to appear for scheduled

exam
All fees forfeited
Emergency Exam Cancellation

Form sent to the Academy
View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination.

Emergencies
If a candidate will be unable to keep his/her exam appointment due to an emergency situation that arises within
five (5) days prior to his/her exam date, the candidate is required to submit an Emergency Cancellation Form
and official documentation to the Academy at certification@acrpnet.org. This information must be received up
to seven (7) calendar days after the candidates scheduled exam date. The following situations will be
considered with documentation:
Emergency room visit or hospitalization

Severe medical condition requiring hospitalization
Death of an immediate family member (e.g., spouse, child/dependent, parent, grandparent, sibling)
Call to active military duty
Jury duty
25
Exam Format
Exam Structure and Delivery
The CRA, CRC, and PI Exams are each designed as practice-based exams for individuals involved in the
performance of the essential duties within their respective roles as a clinical research associate, clinical research
coordinator, or principal investigator, to assess proficiency of the five (5) core knowledge areas:
1.
2.
3.
4.
5.
Investigational Product Management

Protocol
Safety
Trial Management
Trial Oversight
The ACRP Exam consists of 125 multiple-choice questions (25 of these questions are pre-test items and do not
affect a candidates score. These items are not identified to candidates). Candidates are presented with a
question and are asked to choose the single best answer from the four options provided. Only one answer is
correct. The questions test knowledge at the recall, application, and analysis level, not just a recitation of facts.
Some questions use hypothetical scenarios. The exam content is based on a process of expert peer review,
performed by the Global CCRA, CCRC, and CPI Exam Committees. There are no trick questions on the exam,
and there is no penalty for guessing.
The ACRP Exams are administered at computer terminals at secure testing centers. The candidate is provided
with a brief tutorial on navigating the exam, prior to the official start time. Each candidate is allowed a maximum
of three (3) hours to complete the 125 questions. Questions can be skipped, marked for review, and returned to
at any time prior to submitting the Exam for scoring. Results are provided upon the conclusion of the Exam.
Details can be found in the Taking the Exam section.
Language
The Exam is provided in English.

Exam candidates may bring a hard-copy (Electronic dictionaries are not permitted) English-German/ Spanish/
Chinese/ Hindi/ etc. translation only (word-to-word) dictionary to the exam. Dictionaries containing any word
definitions or other extraneous markings are strictly prohibited. The dictionary will be inspected by the proctor
prior to and after the exam is completed. Any attempt to compromise the exam will be grounds for immediate
dismissal from the site, invalidation of the exam score, and possible legal action. No additional time is given to
those using a translation dictionary.
26
Exam Content and Preparation

Preparation to take the CCRA, CCRC, or CPI Examination can begin as early as one decides to pursue
Certification. It is recommended that exam candidates begin to prepare three (3) to six (6) months prior to
attempting an exam. Understanding the exam content, as well as how to apply ones knowledge and experience
while taking the exam, is essential to successfully becoming certified.
What is Covered on the Exam?
The Examination is intended to assess your proficiency of the body of knowledge required to perform in your job
role in clinical research. The knowledge and tasks that are being tested are based on current practice in clinical
research. The research was conducted through an international job analysis to determine what content should
be tested. It is testing your knowledge of what is required to perform in your role safely and effectively, with
grounding in ICH GCP and the application of those guidelines in the conduct of your job duties and
responsibilities. The exam does not cover country-specific (FDA, EMA, etc.) regulations. It is not testing how
your employer or you personally carry out those duties.
The Examination is specific to the role that CRAs/ CRCs/ PIs play in the conduct of a clinical trial and differs
between designations. The exam content expects that you will have a basic working knowledge of general
laboratory terms, tests, and procedures, as well as how to perform basic math. It requires a general working
knowledge of the roles and responsibilities of CRAs/ CRCs/ PIs, even if your employer does not require you to
function in that role.
No two candidates come to the exam with the same knowledge base. Since experience and educational
backgrounds are unique, these differences must be taken into consideration when determining a study method.
Although some individuals may take the exam without any preparation, the majority become involved in some
form of exam preparation. Because the exams measure proficiency of the application of the knowledge required
to be an effective CRA, CRC, or PI, it is impossible to train or teach to the exam. The best preparation is to
understand the CRA/ CRC/ PI knowledge requirements (see the Detailed Content Outline specific to your
program) and their application to clinical research.
A candidate who has met the eligibility requirements to sit for the examination should have the knowledge
needed to take and pass the examination. You might want to review the Detailed Content Outline for topics or
subtopics with which you are less familiar. If you find a particular area with which you are not familiar or
comfortable, that would be an area on which to focus your study or review. Or, you may want to do a surface
review of all the content areas, even those you believe you know well.
Because of the nature of the exam, there is not one comprehensive source to go to in order to study. However,
the Academy does recommend that you review the content areas covered on the exam by using the Detailed
Content Outline, as further explained below.
To be certified, CRAs, CRCs, and PIs are expected to have general knowledge of:
laboratory terminology, tests, and procedures
basic math, including adding, subtracting, multiplying, dividing, and calculating percentages
27
What is Covered on the Exam?

Detailed Content Outline
The DCO is derived from the 2010 ACRP Job Analysis Survey, a careful description of the tasks performed by
clinical research coordinators. Nearly 4,000 clinical research professionals participated in the 2010 survey. This
survey is conducted every five (5) years. The DCO is updated accordingly and the exam questions revised to
reflect any changes in practice. Each question on the exam is based on this outline. Therefore, to prepare to take
the exam, one should study this outline and especially consider the underlying knowledge, skills, and abilities
needed to perform in his/ her role as a clinical research associate, clinical research coordinator or principal
investigator. To be certified, CRAs, CRCs, and PIs are expected to have proficiency in five (5) core knowledge
areas found on the Detailed Content Outline (DCO) for their respective Exam.
Click the image below to view the full DCO content by program:
Study Texts
In order to prepare for the exam, all candidates should review and be familiar with the relevant regulations
from:
ICH Guidelines (E2A, E6, E8, E9)

Declaration of Helsinki (latest version)
The most current copy of the ICH Guidelines and other regulatory materials may be found on the following
websites:
ICH Guidelines: www.ich.org (Go to Work Products/ICH Guidelines/Efficacy Guidelines)

Declaration of Helsinki: www.wma.net/en/20activities/10ethics/10helsinki/index.html
28
Certification Exam Abbreviation List
The Abbreviations List, shown here, is also accessible on each screen during the exam. You can expect to see the following
terms abbreviated as shown.
Certification Exam Abbreviation List

ADR
Adverse Drug Reaction
AE
Adverse Event
ALT
Alanine transaminase
AST
Aspartate transaminase
b.i.d.
twice a day
BP
BUN
C
CIOMS
CK
blood pressure
Blood Urea Nitrogen
Celsius
Council for International Organizations of Medical Sciences
Creatine Kinase
CRA
Clinical Research Associate
CRC
Clinical Research Coordinator
CRF
Case Report Form
CRO
Contract Research Organization
CV
Curriculum Vitae
DCF
Data Clarification Form
IDMC/DSMB
Internal Data Monitoring Committee / Data and Safety Monitoring Board
ECG
Electrocardiogram
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
EKG
Electrocardiogram
FEV1
Forced Expiratory Volume in 1 Second
GCP
Good Clinical Practices
GI
Gastrointestinal
GLP
Good Laboratory Practices
GMP
Good Manufacturing Practices
hCG
Human Chorionic Gonadotrophin
HMO
Health Maintenance Organization
IB
Investigator's Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization
29
IP
IRB/IEC
Investigational Product
Institutional Review Board/Independent Ethics Committee
LAR
Legally Acceptable Representative
MAO
Monoamine Oxidase
mcg
microgram
mmHg
Millimeteres of mercury
NSAID
Non-Steroidal Anti-Inflammatory Drug
PI
Principal Investigator
PK
Pharmacokinetics
p.r.n.
as needed
QA
Quality Assurance
QC
Quality Control
q.d.
once a day
QTc
ECG / EKG QT interval corrected for heart rate
RBCs
Red Blood Cells
SAE
Serious Adverse Event
SMO
Site Management Organization
SOP
Standard Operating Procedure
SUSAR
Suspected Unexpected Serious Adverse Reaction
t.i.d.
three times a day
wBCs
White Blood Cells, or leukocytes
Steps to Preparing for the Exam

STEP 1: Assess your own professional experience. Read carefully through the Detailed Content Outline
(DCO) for the exam you are going to take. Compare the detailed description of knowledge and tasks,
plus the proportion of questions, to your own professional experience. Rate your relative skill level and
experience on a scale of 05 (0 = no experience) as an indicator of how prepared you are for each
section and where to invest more of your study focus in preparing for the exam. While you personally
may have limited experience with certain job functions due to your job description with your employer,
success on the exam requires you to demonstrate competency in all areas of the exam.
STEP 2: Start early and plan ahead. Dont wait to receive your Eligibility Notice. You must complete and
submit your detailed application at least three (3) weeks before the exam. Dont leave this until the last
minute! Focus some learning time on reading in every content category, but spend extra time reading in
those categories where your experience is limited. Match your study efforts in relation to the time you
have available and the specific study needs you have identified for yourself.
STEP 3: Schedule your study time. If you decide to set up a study group, you should hold weekly
meetings that will take about two hours on one day/evening every week. Schedule flexible blocks of time
into your personal schedule. The key is not to memorize what you read, but to understand concepts
30
behind ICH/GCP and best practices in each knowledge category area to supplement your experience. Be
sure you understand how your SOPs differ in relation to ICH/GCP.
STEP 4: Organize your study notes. It may help you to organize your study notes, articles, summaries,
etc. in a binder using either the five (5) exam categories, or your own index. Let your experience guide
you in the content areas you are most comfortable with and focus more time in your weaker areas or on
those areas with which you are least familiar. Create flashcards to use as study aids.
STEP 5: Choose the methods that are right for your study plan. Choose a mentor or colleague who has
more experience in the areas in which you are less familiar and ask him/her to review concepts with you.
As you perform your daily responsibilities, think about the underlying principles that lead you to take a
particular course of action.
STEP 6: Stick to your study groups plan. Pick a regular night and show up on time. Each of you has the
same goal, and everyone has something to offer. Sharing reading and exchanging notes is a great way to
lighten the load. Study groups foster friendships and provide an incentive to stay focused on your
collective goal. Complete; dont compete.
STEP 7: Dont panic. Follow the excellent pre-exam advice that the Academy provides, and come to the exam
well-rested and prepared.
ACRP Online Preparation Support
Optional exam preparation support is available for purchase online, from the Certification Exam Preparation
webpage. There are options to purchase components separately or in a package. Visit the webpage for details
and pricing for each option:
Cert Exam Prep Self-Paced eLearning Course

Exam Review Preparation packages
Exam Practice Exercise- an Internet
Cert Exam Prep Classroom Course
Further Study Tips
In addition to reviewing the ICH Guidelines, one way to review is to select texts and training materials you used
when first taking on your role. You can select a publication that you may already have on your bookshelf, or one
that you can borrow from a colleague. You should select books or publications that cover topics found on the
Detailed Content Outline, the ICH Guidelines, or the tenets of GCP.
If you have time, take a workshop or attend a conference session on topics in which you need to become more
familiar. Any professional development courses that cover clinical research topics will add to your knowledge
base and therefore will help you prepare for the exam.
NOTE: The Academy does not sponsor or endorse any specific educational courseseven if the course is
advertised as a prep or review course for the Exam. Courses titled this way are at the discretion of the
organization offering the course. Those creating the course have not had any inside information about the
exam. The same information that is included in this handbook to help you prepare is publicly available to those
31
creating educational content. Participation in these courses may help you learn or review topics covered on the
exam, but you should not expect them to directly cover exam content.
Taking the Exam

It is important for candidates to understand their rights and responsibilities in the secure testing environment of
the Prometric test center. It is recommended that you review the full Policy on Testing Experience Issues.
Exam Appointment Arrival
It is the candidates responsibility to arrive on time for the exam appointment. If the candidate is late by 15
minutes or more, the test center has the authority to turn the candidate away and not permit the candidate to
take the test. Expect the unexpected when planning your arrival:
Plan to arrive 30 minutes prior to your appointment. If you are lost, or will be late, call the test center
using the phone number on your Appointment Confirmation.
Including check-in time, pre-exam procedures (computer tutorial), exam, and post-exam evaluation, be
prepared to stay at the exam site three-and-a-half to four hours.
Candidates denied access due to lateness, must first contact ACRP and pay the $75 rescheduling fee
before being permitted to reschedule the appointment. We will attempt to have an appointment time
rescheduled at the test site within the current exam period, only if one is available. No refunds will be
given if the exam cannot be rescheduled.
If you miss or need to miss your exam appointment due to a medical emergency, illness, accident, or
death in the family, on Exam day, let us know as soon as possible at certification@acrpnet.org and
within seven (7) days of your scheduled appointment. With proper documentation, we can help you!
If you miss your scheduled exam appointment for any other reason, for example, lack of child care,
lateness due to work or traffic, your opportunity to test will be lost.
Rescheduling for any reason is permitted with a $50 fee, by contacting Prometric directly at 800-8536769 or www.prometric.com/ACRP, if rescheduling occurs at least five (5) days prior to your exam
appointment.
TIPS: These can help you focus on the exam and not the unexpected:
Know your travel route and traffic. Plan for a delay.
Prepare for child care
Bring required identification (see below)
Get plenty of rest!
32
Required Identification
To access a secure testing center you, must present proper identification (ID) containing your legal name. Your
legal name MUST match the first name and last name (middle names excluded) listed on your Eligibility Notice
(emailed from ACRP) and on the Appointment Confirmation (from Prometric). Your (ID) must meet each of the
following criteria:
government-issued AND
current (non-expired) AND
photo-bearing AND
signature-bearing identification (ID)
The photo must look like the examinee. Signature on ID must match the signature provided during the sign-in
process.
Examples of proper ID include passport, drivers license, state- or government-issued ID.
Exceptions will be made if:
name discrepancies are minor
parts of hyphenated names are missing
for candidates with two last/family names, one of the two last names appear
informal first names are used (James vs. Jimmy)
Any other differences will result in a candidate being denied from the testing center and result in forfeiture of all
fees paid.
Name changes (due to marriage, for example) are common, but can prevent a candidate access to the exam if
not properly presented. If a candidate is identified by a different name for the exam than that which is listed on
the ID, the candidate will be permitted to the Exam only if the ID is accompanied by a government-issued
certificate supporting the name change (e.g., a marriage certificate or divorce decree with previous and current
name).
If the name listed with ACRP and Prometric is not your legal name, you must submit a Name Change Request to
certification@acrpnet.org immediately.
Exam Security and Test Center Guidelines
The test center is serious about security. You will be presented with Prometric Test Center Regulations upon
arrival at the test site. It is imperative to read the information provided. Those who violate security will not have
their exams scored or processed, and will be required to leave the room immediately. Also, attempting to
remove exam material or content from the test center will result in severe criminal and civil legal consequences.
Once seated, you will follow a brief on-screen tutorial for navigating through the exam. Your exam will begin
after the tutorial and is three hours in length.
Exam content will be transmitted via encrypted electronic file to each exam site to ensure the security of the
exam questions. Computer-based testing allows for different versions of the exam to be offered and for changes
in the sequence of questions; this reduces the likelihood of misconduct and enhances the validity and integrity
of the exam. Each exam will be delivered via individual video-monitored testing carrelsboth to provide better
privacy while the candidate is taking the exam and to prevent unethical behavior.
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Resources Available at the Test Center
You may use the following resources, issued only by the test center:
Hand-held calculator (also an on-screen calculator is available)
White board and dry-erase markers
Noise cancelling head set (Keep in mind that you are sharing a room with other examinees taking tests
of varying lengths.)
An abbreviations list for your specific exam is also available on screen
TIP: Please, please raise your hand at any time if your computer or any of the above tools are not functioning
properly!
MORE TIPS: It is recommended to leave personal items at home. Any and all personal items will be locked in a
locker. Some examples include a purse, keys, wallet, calculators, watch, dictionary (except for non-electronic
word-to-word, English translation only) cell phone, all electronic devices, tissues, outerwear (heavy coats), food,
and all books and papers. Dress in layers
Should you have any questions about the exam experience, please refer to this Handbook and contact
certification@acrpnet.org if you cannot find an answer. We want you to own your success and perform at your
best!
Test-Taking Strategies
Most adults havent taken a standardized exam recently. It can be helpful to be reminded of some key strategies
for how to approach a multiple-choice exam:
Read the entire question before you look at the possible answers.
Come up with the answer in your head before looking at the possible answers; this way, the choices
given on the test won't distract you from focusing on the question.
Read all the choices before choosing your answer so that you select the best one.
Eliminate answers you know are not correct.
There is no guessing penalty, so its always best to take an educated guess and select an answer if you
are uncertain of the answer.
Don't keep on changing your answer; usually your first choice is the right one, unless you misread the
question.
Go through the exam and answer the questions you know first. Mark the others for review and then go
back to those you skipped over. This will ensure that you dont lose time by focusing on one question
you arent sure about.
Exam Results
Computer-based testing provides participants with preliminary results immediately. You will receive printed
results before you leave the test center. Please make sure that you have this important feedback before you
leave as it is the only feedback you will receive regarding your performance on the exam. These on-site notices
are preliminary and candidates are not yet considered certified until official notification of certification status
is received from the Academy. You will not receive another copy of your detailed results but will receive official
confirmation of your certification status will be mailed 30 days following the close of the testing window.
34
Candidates who pass the exam will be sent an official notice of Certification, a certificate, a certification pin, and
Maintenance of Certification information.
Candidates who do not pass the exam are advised to review the content area proficiency ratings and use this
information to assist in preparing for future exams.
Final exam results will not be given out over the telephone or by fax, nor will results be sent to employers,
schools, other individuals, or organizations under any circumstances. Candidates who pass the exam will be
added to the Academy Certification registry unless this option was de-selected at the time of application. The
registry can be accessed at www.avectraacrp.com/Certlist.
Duplicate Certificates
There is a $25 charge for a duplicate certificate if the request is made more than three months after the exam.
Requests may be made in writing by completing and sending the Duplicate Certificate Form to the Academy at
certification@acrpnet.org.
Exam Scores
Prometric, the Academys professional testing partner, scores all exams. One point is granted for each correct
answer. There is no penalty assessed for an incorrect answer; points are scored only for correct answers. The
number of questions answered correctly (or total points) is a candidates raw score.
A candidates raw score is converted to a scaled score. The "Total Scaled Score" will determine whether a
candidate has passed the exam. This scaled score is statistically derived from the candidate's raw score and can
range from 200 to 800. The passing scaled score for each of the exams is 600. The passing score reflects the
minimum amount of knowledge a committee of experts has determined to be appropriate for Certification,
according to accepted test development guidelines.
A criterion-referenced, standard-setting procedure and expert judgment are used to identify the passing point.
The Academy uses the widely accepted Modified Angoff method. A candidate's ability to pass the exam depends
on the amount of knowledge he or she demonstrates, not on the performance of other individuals taking the
exam.
The reason for calculating scaled scores is that different forms or versions of the exam may vary in difficulty. As
new versions of the exams are introduced, a certain number of questions in each content area are replaced by
new questions. These changes may cause one version of the exam to be slightly more or less difficult than
another version.
To adjust for these differences in difficulty, a statistical procedure called "equating" is used. The goal of equating
is to ensure fairness to all candidates. In the equating process, the minimum raw score (number of correctly
answered questions) required to equal the passing scaled score is statistically adjusted (or equated). For
instance, if the exam is determined to be more difficult than the base form of the exam, then the minimum raw
score required to pass will be slightly lower than the passing scaled score. If the exam is a bit easier, then the
passing raw score will be slightly higher than the passing scaled score. Equating helps ensure that the passing
scaled score represents the same level of knowledge, regardless of which version of the exam a candidate takes.
35
A candidate scoring below the minimum scaled score has not been successful on the exam and cannot be
certified. The exam is not scored on a curve. There is no predetermined number of candidates permitted to
pass. Your score does not depend on the other candidates testing with you that day.
Note: The passing point set for the exam cannot be appealed. To score one point below the passing point is to be
unsuccessful on the exam; to score at the passing point or higher is to pass the exam. A score higher than the
passing point is not an indication of a higher proficiency in the subject matter.
Specific questions on the exam and/or answers to exam questions will not be discussed or released. Due to
the security of the item bank and because exam questions can be used on various exams, exam questions will
not be discussed with candidates and candidates may not have access to the exam or their answers.
Scaled Scores and Score-Reporting FAQs
Commonly asked questions and information about scaled scores and score reports is provided below.
1. Why are scaled scores used?
They are used to provide a consistent scale of measurement, so that from one test administration to the next,
the same scaled score represents the same level of knowledge. Each exam administration has multiple exam
forms in use, and some forms may be more difficult than others. A scaled score keeps the level of knowledge
required to pass constant.
2. Why not just use the number of items answered correctly?
This may provide useful information about your performance on different parts of the test, but does not take
into account the difficulty of the items.
3. Is a scaled score the same as a percentage score?
No. Calculation of a percent correct is a way to convert a raw score to another scale, but a scaled score is not
the same as a percent correct. You could calculate percentage scores by dividing the number correct by the
total, for example, a raw score of 9 in a category with 15 total items relates to 60% correct, but a scaled score of
600 does not relate to 60% correct.
4. How should I interpret my performance on the category scores?
When reviewing your proficiency for the major categories, bear in mind that all categories are not equally
difficult. Those areas indicating below proficient are areas where additional study or review would be helpful.
5. Why dont I get a percentage score on my report?
Similar to a raw score, converting your score to a percentage score would not take the difficulty of the items into
account.
6. How is the scaled score computed?
To calculate a scaled score, the raw score required to pass is first set equal to 600. An analogous situation is with
temperature: 0 degree and 32 degrees both represent freezing on different temperature scales. Raw scores
below the passing point are converted in linear fashion to scaled scores below 600; those above the passing
point are similarly converted to scaled scores above 600.
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7. Why do I need a 600 to pass the test?

The amount of knowledge required to pass the test is based on the judgments of the content experts who are
certified in the job role tested. The raw score required to pass relates to the number of correct answers that a
minimally competent (borderline) candidate would be expected to provide, and this raw score is set equal to
600 scaled score units. Different raw scores may be required of different test forms, because all examinations
are not equally difficult. The scaled score of 600 required to pass indicates that, while a different number of
correct answers may be required from one administration to the next, the passing point for all examinations
represents the same level of knowledge.
How Are Certification Exams Developed?

In response to the ACRP membership's numerous requests for professional recognition, two exam committees
were established in 1990; by 1992, the first Certification exams were developed with the assistance of a
professional testing organization. The committeesone each for CRAs and CRCsidentify areas of competency
for testing, develop appropriate test questions, and assist with validation of the exams.
It is important to note that the Academys programs are accredited by the National Commission for Certifying
Agencies, which sets internationally recognized standards for the development and operation of certification
programs. The standards assure that a program is valid, reflects current practice, and treats candidates fairly.
The development of Certification examinations begins with a Job Analysis, which is a survey that goes to
members of a profession to create a definitive description of the tasks required to perform a job role and the
knowledge needed in order to complete those tasks. A Job Analysis Survey is typically conducted every five to
seven years to assure the exam is testing current practice in a job role.
In 2010, the Academy updated its CRA, CRC and PI Job Analyses with a survey sent to thousands of clinical
research professionals, 3,636 of whom responded. The results of the survey identified for the Academy what to
include on the Detailed Content Outlines (DCOs) for each job role. Those task and knowledge statements that
the majority of CRAs, CRCs, and PIs said were essential to their job role and that they performed frequently are
covered on the exam. The results are then incorporated into the CRA, CRC, and PI DCOs.
Individuals who are already certified as a CRA, CRC, or PI are then trained to write test questions. We call these
volunteers Subject Matter Experts, or SMEs. All questions must test knowledge and skills as defined by the
DCO, and must be referenced to specific areas of ICH Guidelines, as described in our candidate handbook. Once
the SMEs have written draft questions, the questions go to the CCRA, CCRC, and CPI Exam Committees for
review. This process is constantly in motion, with new questions being written, current questions being
reviewed, and older or nonperforming questions being retired from the item bank.
One exam committee exists for each exam. The CCRA, CCRC, and CPI Exam Committees consists of a separate
group of currently practicing, certified CRAs, CRCs, or PIs who review, edit, discuss, and rewrite the draft test
questions. Many draft test questions are discarded in the process. Others are completely rewritten or heavily
edited. Each question must meet minimum standards for applicability to the job role. All Exam Committee
members must agree that the answer keyed as correct is, in fact, the only correct answer possible.
Once a draft question is approved by an Exam Committee, it then becomes a pre-test question. All questions are
pre-tested before they are counted toward a candidates score. The exams given to candidates are 125
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questions long, and 100 of them count toward the candidates score while 25 are pre-test questions. This means
the Academy is collecting statistical data on the pre-test items to see if they are well-constructed enough to
appear on the exam as a scored item. Hundreds of candidates answer a pre-test question before it can be
determined if it can be used toward a candidates score.
Once enough data have been collected, analyses are performed on the item statistics in conjunction with the
Academys professional test development partner to see if items have performed well enough to be used. If they
have not performed well (for example, if many candidates are choosing the wrong answer; or each of the four
answers is being selected equally, which indicates test-takers are guessing; or candidates who score well on the
exam overall are selecting a wrong answer), then the questions are set aside for further review and rewriting, or
they may be discarded. Only those questions that demonstrate they are fair to the test taker and identify
proficiency in a candidate are used.
Several diverse groups of volunteers are used to write the questions, review the questions, select questions to
be pre-tested, and select and review questions that actually appear on the exam. The Academy follows a
process that meets international standards for test development and works with a highly regarded testing
partner.
To date, more than 29,000 clinical research professionals have been Certified by the Academy. On average, 75%
of those who sit for an exam pass it.
Reliability Measurements
After every Certification exam, the Exam Committees review the results with the assistance of Prometric, one of
the testing industry's leading firms. Each item is analyzed for appropriate psychometric characteristics. Those
items with poor statistical results are reviewed by the appropriate Exam Committee to ensure that they have
been scored properly. Participant feedback regarding the exam and its contents is also reviewed and taken into
consideration when reviewing the exam and future test items.
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Maintenance of Certification
Once a candidate has achieved Certification, it is valid for two (2) years. In order to continue to be certified and
to continue to use the designation after two (2) years, certificants will need to apply for Maintenance of
Certification.
The Academy requires periodic Maintenance of Certification to ensure that individuals who hold a credential
maintain their ongoing commitment to professional development in their selected area of practice. Through the
Maintenance of Certification requirements, certificants demonstrate expansion and reinforcement of their
knowledge of current practice.
The Academy supports this purpose by requiring appropriate and relevant continuing education activities to
enhance the professional development of certificants. The Maintenance of Certification program also serves to
encourage and recognize individuals who participate in ongoing professional development.
CCRAs, CCRCs, and CPIs must maintain every two (2) years from the time of original Certification. The two-year
Maintenance of Certification cycle is based on the frequency of change in the clinical research field.
Maintenance of Certification requires the completion of 24 documented hours (referred to as points). These
points can be earned through professional development and/or continuing involvement. Updated information
is available at www.acrpnet.org/Maintenance.
Maintenance Requirements
To maintain Certification successfully, certificants must:
1. Satisfy the 24 points requirements every two years (or pass the CRC/ CRA/ PI Certification exam) prior to
your Certification expiration date.
2. Document the required points (or exam results letter) on the Maintenance application.
3. Submit the completed application together with appropriate payment by the expiration date.
The 24 points requirement for CPIs is different from those required for CCRAs and CCRCs, as noted below.
CCRAs and CCRCs, 24 Points Requirements:
At least 12 points from Research-specific topics in Continuing Education (i.e. training, coursework)
The other 12 points can be earned through any combination of Continuing Education from Research,
Disease/Bodily Systems/Healthcare related topics OR Continuing Involvement activities (research
related involvement; see chart)
CPIs, 24 Points Requirements:
At least 8 points from Research-related topics in Continuing Education (i.e. training, coursework)
At least 12 points from Continuing Involvement activities (research related involvement; see chart)
The other 4 points can be earned through any combination of Continuing Education from Research,
Disease/Bodily Systems/Healthcare related topics OR Continuing Involvement
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Maintenance requirements are outlined more specifically in the Maintenance Handbook. Also, View Policy on
Continuing Competency and Maintenance for CCRA-CCRC or Policy on Continuing Competency and
Maintenance for CPI.
Frequently Asked Questions (FAQs)

How will I know if my exam application was received?
An e-mail confirmation is automatically sent once payment is applied. Applicants will also be sent an e-mail that
confirms that the application has entered the eligibility review process.
NOTE: Confirmations of receipt do not confer eligibility. A separate notification will be sent regarding an
eligibility decision. Please take any necessary steps to prevent filtering of ACRP e-mails.
How will I know if I am eligible to take the exam?
An e-mail will be sent within ten (10) days after receipt of the application to notify you of your eligibility status
or any deficiencies that may exist.
What should I bring to the test center?
Bring an appropriate identification, as described in this handbook. Online and handheld calculators will be
provided.
What happens if I need to cancel the exam?
If a candidate has already scheduled an appointment with Prometric, then:
1. Contact Prometric to cancel the appointment, at www.prometric.com/ACRP or 800.853.6769.
2. Pay the appropriate cancellation fee to Prometric (fees apply between 30 5 days prior to the set
appointment).
3. Notify the Academy in writing at certification@acrpnet.org once the appointment is cancelled.
If the candidate has not yet scheduled an appointment with Prometric, then the candidate should notify the
Academy in writing at certification@acrpnet.org.
If you cancel at least five (5) days prior to the exam, you will receive a refund of the exam fee only. No refunds
are available fewer than five (5) days prior to the exam.
What if I need to retake the exam?
An exam may be attempted only once during each testing window. Candidates may reapply for the exam and
reattempt to take it during any future testing window however candidates, who are unsuccessful at their first
attempt, are offered the opportunity to retest for the next exam period for a reduced fee. In this instance, the
candidate submits an application with the exam fee only. The application fee is waived.
What happens if I miss the application deadline?
All applications must be received by the Academy (not postmarked) by the application deadline. Faxed
applications will be accepted. If you miss the deadline, you may reapply when the applications become available
for the next scheduled exam date. Your application will not be returned to you.
40
What tools does ACRP have available to help me prepare for the exams?
The Detailed Content Outlines (DCOs), and therefore the content of the Exam should be used to build your
study plan. An electronic, downloadable ICH Guidelines and Declaration of Helsinki Booklet is available, online
as well.
Optional Exam Preparation options are available for purchase online at www.acrpnet.org/examprep.
When can I expect the official confirmation of my exam results?
Official confirmation of results will be mailed 30 days following the close of the testing window. Candidates who
pass the exam will be sent an official notice of Certification, a certificate, a certification pin, and Maintenance of
Certification information.
What is the Academys Maintenance of Certification process?
The Academy requires periodic Maintenance of Certification to ensure that individuals who hold a CCRA, CCRC,
or CPI credential maintain their ongoing commitment to professional development in their selected area of
practice. Through the Maintenance of Certification requirements, certificants demonstrate expansion and
reinforcement of their knowledge of current practice.
Certificants must maintain every two (2) years from the time of original Certification. Maintenance of
Certification requires the completion of 24 documented professional development and/or continuing
involvement points. For CCRAs and CCRCs, a minimum of 12 of the 24 hours completed must be from
participation in Continuing Education activities specific to research topics. For CPIs, a minimum of 12 of the 24
hours completed must be from participation in Continuing Involvement and a minimum of 8 points must come
from participation in Continuing Education activities specific to research topics. For a complete listing of
acceptable activities, by program, please visit the main Maintenance of Certification web page and the
following requirements webpages:
Maintenance of Certification Requirements for CCRA/ CCRC Designations.
Maintenance of Certification Requirements for the CPI Designation
View the full Policy on Continuing Competency and Maintenance for CCRA-CCRC and Policy on Continuing
Competency and Maintenance for CPI
What happens if I do not maintain my Certification?
Individuals who fail to properly maintain their Certification(s) will be decertified for failure to maintain by the
specified deadline. You will receive a two-week grace period in which you may maintain with submission of the
required professional development and/or continuing involvement points. If you do not respond by the end of
the grace period, you will be decertified and will receive notification of this action.
Can I reinstate my Certification if it has expired?
A certificant who has had a credential revoked due to not meeting the Maintenance of Certification
requirements may re-apply for Certification by examination. The individual must meet the current eligibility
requirements, pay all required fees, and successfully pass the exam.
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Appendix
The Academy Certification Policy Manual
All current Academy of Clinical Research policies are located in the Academy Certification Policy Manual.
Detailed Content Outline (DCO) for Certified Clinical Research Coordinator
clinical research coordinators. Nearly 4,000 clinical research professionals participated in the 2010 survey. This
reflect any changes in practice.
Each question on the exam is based on this outline. Therefore, to prepare to take the exam, one should study
this outline and especially consider the underlying knowledge, skills, and abilities needed to perform as a clinical
research coordinator. To be certified a CRC is expected to have proficiency in five (5) core knowledge areas
found on the Detailed Content Outline (DCO) for their respective Exam.
Note: The percentage of questions allocated to each of the five (5) core knowledge areas is noted within the
DCO.
Certified Clinical Research Coordinators (CCRCs) shall have proficiency in:
I.
Investigational Product Management (7%)
Ensure adequacy of investigational product and other supplies at site

Ensure randomization and emergency codes of investigational product have been maintained
Ensure proper storage, dispensing, handling, and disposition of investigational product and
other supplies
Reconcile investigational product and other supplies
Maintain accountability of investigational product
Prepare investigational product according to the protocol
Dispense investigational product according to the protocol
Retrieve investigational product and calculate subject compliance
Maintain randomization and emergency codes of investigational product dispensing
Prepare emergency use report
Using knowledge of:

Investigational product (e.g., package insert, report of prior investigations, Investigator's
Brochure)
Investigational product inventory
Investigational product accountability
Investigational product storage
Packaging and labelling
Supplemental/rescue/comparator product
Investigational product compliance (e.g., protocol, standard operation procedures, local
governance)
Accountability records
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II.
Protocol (13%)
Evaluate protocol for feasibility

Evaluate congruence of data collection tools (e.g., case report form (CRF), electronic data
capture (EDC)) with the study protocol
Verify the eligibility of potential trial subjects
Contribute to protocol development
Coordinate protocol approval process
Review protocol for feasibility
Review protocol during Investigators meeting
Execute study per protocol
Recommend and implement protocol amendments
Using knowledge of:

Protocol development
Protocol submission and approval procedures
Clinical trial phase
Study design characteristics (e.g., double-blind, crossover, randomized)
Study objective
Description of procedures
Amendment submission and approval procedures
Inclusion/exclusion criteria
Statistical plan
III.
Safety (16%)
Assess safety during trial participation

Minimize potential risks to subject safety
Oversee safety risks (e.g., clinical holds, product recalls)
Report required adverse events to regulatory authorities and/or IRB/IEC
Ensure adverse events reporting is documented (e.g., serious, severe, moderate, mild, expected,
unexpected)
Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts)
Handle medical monitor oversight
Conduct study-related procedures and monitor the safety of the trial subjects and
investigational staff
Manage and motivate the investigational staff and other disciplines involved, and take measures
to minimize any potential risks
Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit
progress reports to the IRB/IEC per requirements
Review common laboratory values and alerts
Determine and document the causality of adverse events
Identify expected or unexpected results associated with investigational products
Implement Investigators plan of action for management of adverse event (e.g., stop
investigational product; call, retest, treat subject)
Maintain follow-up to determine resolution of adverse event
Report serious adverse event to Sponsor/CRO and IRB/IEC
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Classify adverse events (i.e., serious, severe, moderate, mild, expected, unexpected)
Record adverse event and relevant information on source document
Document reasons for subject discontinuation (i.e., causes, contact efforts)
Document follow-up medical care for study subjects, as applicable
Conduct safety monitoring/reporting activities
Initiate un-blinding procedures
Using knowledge of:

Investigators Brochure
Safety monitoring
Safety and clinical databases
Subject safety issues (e.g., toxicity, significant lab values)
Adverse events reporting
Serious adverse events reporting
Safety reporting requirements
IV.
Trial Management (58%)
Verify investigator/site feasibility

Develop timelines for conducting and completing the clinical trial
Prepare and conduct initiation activities
Ensure appropriate training of the investigational staff
Develop a recruitment strategy and study management plan
Follow a recruitment strategy and study management plan
Schedule and coordinate pre-study site visit
Identify minimum regulatory document requirements for site trial master file (e.g., countryspecific regulatory documents)
Ensure IRB/IEC review/approval of study and study documents
Facilitate site budget/contract approval process
Submit documents to regulatory authorities
Document and communicate site visit findings
Ensure clinical trial registry requirements are met
Ensure timely review of study data (e.g., laboratory results, x-rays)
Maintain current vendor credentials (e.g., lab certification/licensure and normal ranges)
Prepare and conduct close-out monitoring visit(s)
Prepare study summary and/or close-out letter for IRB/IEC
Document protocol deviations/violations
Evaluate study for feasibility
Schedule subjects
Obtain informed consent and screen trial subjects
Prepare study documents for IRB/IEC and/or sponsor review/approval
Prepare study documentation (e.g., schedule of events, description of procedures)
Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g.,
protocol procedures, EDC)
Select the investigational staff and assign roles and responsibilities
Develop a recruitment strategy and site study management plan
Transmit CRFs to Data Management
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Review CRF queries from Data Management

Coordinate study monitoring visits
Select and manage local vendors (e.g., laboratory, x-ray, MRI)
Draft study specific tools (e.g., source document, tracking tools)
Obtain, negotiate, and seek approval of study budgets and clinical trial agreement
Conduct subject visits according to requirements
Implement corrective actions plans
Maintain trial master file (e.g., regulatory binder)
Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO
Maintain standards for handling hazardous goods (e.g., IATA)
Manage study supplies (e.g., lab kits, case report forms)
Maintain equipment (e.g., calibration and preventive maintenance)
Manage study record retention and availability
Manage financial agreements
Comply with subject privacy regulations
Pre-screen telephone calls for eligibility requirements
Maintain subject screening/enrollment log
Collect, record, and report accurate and verifiable data
Manage study issues
Using knowledge of:
Site Activities
Contract budget negotiations and approval process
Monitoring guidelines/plan and tools
Disposition of unused study-related materials (e.g., CRF at end of study, destruction of lab
kits)
Equipment and supplies (e.g., x-ray, computer, lab kits)
Equipment and supply storage
Pre-study site visit
Investigator's meeting
Site initiation
Monitoring visit
Close-out visit
Site monitoring visit log
Site signature log
Delegation listing
Trial master file (e.g., site, sponsor)
Regulatory documents
Record retention
Visit reports (e.g., initiation, close-out)
Final report
Progress reports
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Protocol Compliance
Project feasibility
Study project tools
Sample collection, shipment, and storage
Study management plan (e.g., timelines, data management)
Good Clinical Practice
Procedure manuals
Protocol deviations
Subject Scheduling, Screening, Recruitment, and Retention
Project timelines
Recruitment plan/strategies
Subject compliance
Subject visit logistics
Subject selection, screening, and recruitment
Subject retention
Subject discontinuation
Clinical trial registry
PI Oversight/Qualifications
Staff qualifications
Staff roles and responsibilities
Plan for staff oversight
Investigator qualifications/site selection (e.g., therapeutic area, education, experience)
Plan for ancillary staff education
CRF/Source Documents
Data management activities
Communication documentation (e.g., telephone, email)
Data management plan
Data query resolution
Electronic data (e.g., electronic health records, electronic case report forms)
Case Report Form
Essential documentation, subject related and non-subject related (e.g., past medical
records, lab reports, protocol, IRB approvals)
Source documentation
Consent/Assent
Vulnerable subject populations
Communication with subjects
Protection of human subjects
Subject reimbursement
Subject privacy regulations
Informed consent
Indemnification/insurance
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V.
Trial Oversight (6%)
Ensure consistency between the sites standard operation procedures (SOPs) and the study
requirements
Ensure investigator/site protocol compliance
Facilitate investigator/site corrective actions
Ensure compliance with electronic data requirements (e.g., electronic health records, eCRF)
Ensure adequate site management
Prepare the study site for audits and inspections
Respond to or facilitate response to audit/inspection findings
Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation
of slides, freezing, refrigeration)
Ensure proper adverse event reporting by the investigator
Escalate problems to appropriate in-house management
Investigate potential fraud and misconduct
Report potential fraud and misconduct
Ensure follow-up medical care for study subjects is documented, as applicable
Ensure adequate consent and documentation
Ensure staff, facility, and equipment availability throughout the study
Ensure compliance with study requirements and regulations
Prepare for audits, inspections, and follow up
Ensure access to source data by authorized parties, in accordance with ICH-GCP, and protect
confidentiality by limiting unauthorized access
Ensure that IRB/IEC documentation is adequate and that details of the IRB/IEC composition are
on file
Using knowledge of:

Issues management (e.g., escalation)
Audit preparation
Regulatory standards
Audit documents
Project monitoring guidelines
Project investigator supervision requirements
47
Detailed Content Outline (DCO) for the Clinical Research Associate Exam
clinical research associates. Nearly 4,000 clinical research professionals participated in the 2010 survey. This
reflect any changes in practice.
research coordinator. To be certified a CRA is expected to have proficiency in five (5) core knowledge areas
DCO.
Certified Clinical Research Associates (CCRAs) shall have proficiency in:
I.
Develop and update the instructions for use of investigational product

Initiate shipment of investigational product to site
other supplies
Using knowledge of:

Brochure)
Product development
Supplemental/ rescue/ comparator product
governance)
48
II.
Protocol (20%)
Review product development plan

Identify study objective/design
Develop the protocol (e.g., inclusion/exclusion criteria, procedures, schedule of events, safety
and efficacy parameters)
Evaluate protocol for scientific soundness
capture (EDC) with the study protocol
Review protocol during investigators meeting
Recommend and Implement protocol amendments
Using knowledge of:
III.
Study objective
Statistical plan
Safety (25%)

unexpected)
49
Using knowledge of:
IV.
Safety monitoring
Safety reporting requirement

Review, clarify, and obtain data changes from sites
Develop Case Report Forms (e.g., CRFs, eCRFs)
Develop CRF completion guidelines
Develop monitoring guidelines/plans
Develop project tools
Prepare and conduct interim monitoring visit(s)
Prepare and conduct close-out monitoring visit(s)
Reconcile payments to sites per contract
Reconcile safety and clinical databases
Conduct co-monitoring/training visits
Perform remote monitoring activities
Transmit CRFs to data management
Review CRF queries from data management
50

Manage study issues
Using knowledge of:
Site Activities
Project feasibility
Project timelines
Study project tools
data management activities
Investigator qualifications/ site selection (e.g., therapeutic area, education, experience)
Disposition of unused study-related materials (e.g., CRF at end of study, destruction of lab kits)
Equipment and supplies (e.g., x-ray, computer, lab kits) and storage
Site initiation
Monitoring visit
Close-out visit
Site signature log
Delegation listing
Recruitment plans/strategies
Subject compliance
Subject retention
Good Clinical Practice (GCP)
Record retention
51
V.
Case Report Form (CRF/eCRF)

Final report
Progress reports
Essential documentation, subject related and non-subject related (e.g., past medical records, lab
reports, protocol, IRB approvals)
Informed consent
Procedure manuals
Protocol deviations
requirements
Oversee vendors (e.g. Contract Research Organizations (CROs)
on file
Using knowledge of:

Audit preparation
Audit documents
52
Detailed Content Outline (DCO) for the Certified Principal Investigator
Principal Investigators. Nearly 4,000 clinical research professionals participated in the 2010 survey. This survey is
conducted every five (5) years. The DCO is updated accordingly and the exam questions revised to reflect any
changes in practice.
research coordinator. To be certified, a PI is expected to have proficiency in five (5) core knowledge areas
DCO.
Certified Principal Investigator (CPIs) shall have proficiency in:
I.

other supplies
Prepare investigational product according to the protocol
Dispense investigational product according to the protocol
Prepare emergency use report
Using knowledge of:

Brochure)
Product Development
Supplemental/ rescue/ comparator product
governance)
53
II.
Protocol (10%)
Review product development plan

Identify study objective/design
Develop the protocol (e.g., inclusion/exclusion criteria, procedures, schedule of events, safety
and efficacy parameters)
Evaluate protocol for scientific soundness
capture (EDC) with the study protocol
Review protocol during Investigators meeting
Recommend and Implement protocol amendments
Using knowledge of:

Study objective
Statistical plan
III.
Safety (25%)

Report required adverse events to regulatory authorities and/or IRB/IEC
unexpected)
Handle medical monitor oversight
Ascertain the safety and expected therapeutic effects of the investigational product by verifying
the preclinical and clinical research done so far (using the investigator brochure)
54
Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit
progress reports to the IRB/IEC per requirements
Determine and document the causality of adverse events
Implement Investigators plan of action for management of adverse event (e.g., stop
investigational product; call, retest, treat subject)
Report serious adverse event to Sponsor/CRO and IRB/IEC
Classify adverse events (i.e., serious, severe, moderate, mild, expected, unexpected)
Record adverse event and relevant information on source document
Document reasons for subject discontinuation (i.e., causes, contact efforts)
Document follow-up medical care for study subjects, as applicable
Initiate unblinding procedures
Using knowledge of:
IV.
Safety monitoring
Safety reporting requirements

Plan and conduct investigators meeting(s)
Review, clarify, and obtain data changes from sites
Develop Case Report Forms (e.g., CRFs, eCRFs)
55
Prepare study summary and/or close-out letter for IRB/IEC
Reconcile payments to sites per contract
Reconcile safety and clinical databases
Arrange site/investigator indemnification/insurance
Evaluate study for feasibility
Schedule subjects
Obtain informed consent and screen trial subjects
Prepare study documents for IRB/IEC and/or sponsor review/approval
Prepare study documentation (e.g., schedule of events, description of procedures)
Select the investigational staff and assign roles and responsibilities
Develop a recruitment strategy and site study management plan
Transmit CRFs to Data Management
Review CRF queries from Data Management
Select and manage local vendors (e.g., laboratory, x-ray, MRI)
Obtain, negotiate, and seek approval of study budgets and clinical trial agreement
Conduct subject visits according to requirements
Verify sponsor indemnification/insurance
Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO
Maintain standards for handling hazardous goods (e.g., IATA)
Maintain equipment (e.g., calibration and preventive maintenance)
Manage study record retention and availability
Manage financial agreements
Pre-screen telephone calls for eligibility requirements
Maintain subject screening/enrollment log
Collect, record, and report accurate and verifiable data
Manage study issues
Using knowledge of:

Project feasibility
Project timelines
Study project tools
Data management activities
56

Investigator qualifications/ site selection (e.g., therapeutic area, education, experience)
Plan for ancillary staff education
Sample collection, shipment and storage
Disposition of unused study-related materials (e.g., CRF at end of study, destruction of lab kits)
Equipment and supplies (e.g., x-ray, computer, lab kits) and storage
Site initiation
Monitoring visit
Close-out visit
Site signature log
Delegation listing
Recruitment plans/strategies
Subject compliance
Communication with subjects
Subject retention
Good Clinical Practice
Record retention
Case Report Form
Final report
Progress reports
Essential documentation, subject related and non-subject related (e.g., past medical records, lab
reports, protocol, IRB approvals)
Informed consent
Procedure manuals
Protocol deviations
57
V.
requirements
Oversee vendors (e.g. Contract Research Organizations (CROs))
on file
Using knowledge of:

Audit preparation
Audit documents
58

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CERTI

Welcome to the Academy of Clinical Research Professionals Certification

About the Academy of Clinical Research Professionals

Exam Scheduling ................................................................................................................................................... 23

The Academy Certification Policy Manual ................................................................................................................. 42

Quick Reference Questions

Was my Exam application received?

I didnt receive notification of eligibility.

What is my Prometric testing ID number?

Yes, contact Prometric;

Can I reschedule my appointment from

Yes, contact Prometric;

Can I reschedule my appointment from 5

Yes, contact Prometric;

No. Rescheduling is not

Can I reschedule my appointment from 4

Can I transfer/cancel my application

*Yes. First, contact Prometric to

*Yes. First, contact Prometric to

E-mail the Academy:

Can I transfer/cancel my application from

*Yes. First, contact Prometric to

Cancelling is not permitted

Post Exam Questions

General Contact Information

Apply for Eligibility

What is Required for Certification?

Eligibility Requirements of Certification

Clinical Research Coordinator (CCRC) Program

CCRC Eligibility Requirements

CCRC Essential Duties

Document adverse events;

CCRC Eligibility Requirements

Associates or Bachelors degree

Clinical Research Associate (CCRA) Program

CCRA Eligibility Requirements

CRA Essential Duties

Verify Investigational Product accountability;

Conduct routine monitoring visits on behalf of the clinical trial sponsor.

CCRA Eligibility Requirements

Bachelors degree (or higher)

Other, such as LPN, LVN, Medical

Principal Investigator (CPI) Program

CPI Eligibility Requirements

Responsible for the safe and ethical conduct of a clinical trial;

Clinical Research Education Programs- Substitution for

Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation

Application for Certification

Completing the Application Form

Have the following information ready before applying:

Proof of Employment (Required for CPI Only)

Application and Exam Fees

Submitting the Application

Documents Required to be Submitted WITH Application

Upload documents as part of application or

Applications must be received by February 1, 2015.

Complete the Application

Submit the Application

Transfer Application to Next Exam Window

Refunds and Cancellation of Application

Ineligibility Decision Appeals Process

Services for People with Disabilities

Wheelchair access is available at all established test centers.

To request a reasonable accommodation, one is required to submit at the time of application: