Important Definitions - CR and CDM

GLOSSARY OF
COMMON TERMS IN
CR AND CDM
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CLINICAL RESEARCH AND CLINICAL TRIAL
• CLINICAL RESEARCH : Clinical research is a branch of healthcare science that determines the safety and
effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for
human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
• Clinical research involves methodological and systemic study of drugs, devices or biological vaccines used
for the diagnosis, prevention or treatment of diseases. Main objective of CR is to determine the safety and
efficacy or to determine the Pharmacokinetics and Pharmacodynamic properties and its potential effects in
human subjects.
• CLINICAL TRIAL : A clinical trial is a research program conducted with patients to evaluate a new medical
treatment, drug, or device. The purpose of clinical trials is to find new and improved methods of treating,
preventing, screening for, and diagnosing different diseases.
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REGULATORY BODIES/AGENCIES
• REGULATORY BODY: A regulatory body is a public organization or government agency that is set up to
exercise a regulatory function. This involves imposing requirements, conditions or restrictions, setting
the standard for activities, and enforcing in these areas or obtaining compliance.
• FOOD AND DRUG ADMINISTRATION (FDA): The Food & Drug Administration (FDA) is
responsible for the oversight of drugs, medical devices, vaccines, blood products and biologics,
establishing rules for testing, clinical trials and approval of new products. The FDA monitors safety,
medical errors and adverse reactions to treatment, alerting the health care industry of risks associated
with treatments. The FDA also monitors food products to ensure safety of your food supply.
DIFFERENT REGULATORY BODIES
• US – Food and Drug Administration (FDA)
• UK – Medicine and Health Care Product Regulatory Agency (MHRA)
• Australia - Therapeutic Goods Administration (TGA)
• Canada – Health Canada

• Japan – Ministry of Health, Labor and Welfare (MHLW)
• European Union - European Medicines Agency

• India – Central Drug Standards Control Organization (CDSCO)
• China (People’s Republic) – State Food and Drug Administration (SFDA)
Intervention – A procedure or treatment such as a drug,

nutritional supplement, gene transfer, vaccine, behavior or device
modification that is performed for clinical research purposes.
Observational study - A study in which the investigators do not
seek to intervene, and simply observe the course of events.
Changes or differences in one characteristic (e.g., whether or not
STUDIES/TRIALS people received the intervention of interest) are studied in relation
IN CLINICAL to changes or differences in other characteristic(s).
RESEARCH … • Open clinical trial - A clinical trial in which the investigator and
participant are aware which intervention is being used for
which participant (i.e., not blinded).
• Parallel group trial - A trial that compares two groups of
people concurrently, one of which receives the intervention of
interest and one of which is a control group.
• Treatment Research generally involves an intervention
such as medication, psychotherapy, new devices, or new
approaches to surgery or radiation therapy.
TYPES OF
• Prevention Research looks for better ways to prevent
RESEARCH
disorders from developing or returning. Different kinds of
STUDIES prevention research may study medicines, vitamins,
vaccines, minerals, or lifestyle changes.
• Diagnostic Research refers to the practice of looking for

better ways to identify a particular disorder or condition.
TYPES OF RESEARCH STUDIES
Screening Research aims to find Quality of Life Research explores

the best ways to detect certain ways to improve comfort and the
disorders or health quality of life for individuals with
conditions. a chronic illness.
Genetic studies aim to improve

Epidemiological studies seek to
the prediction of disorders by
identify the patterns, causes, and
identifying and understanding
control of disorders in groups of
how genes and illnesses may be
people.
related.
CONTD …
Randomization - A method based on chance by which

study participants are assigned to a treatment group.
Randomization minimizes the differences among groups
by equally distributing people with characteristics among
all the trial arms.
Randomized trial - A study in which participants are

randomly (i.e., by chance) assigned to one of two or more
treatment arms of a clinical trial. Occasionally placebos are
utilized.
BIOLOGY
• BIOLOGICAL DRUG - A substance that is made from a living organism or its products and is used
in the prevention, diagnosis, or treatment diseases. Biological drugs include antibodies, interleukins,
and vaccines. Also called biologic agent or biological agent.
• BIOAVAILABILITY - The proportion of a drug or other substance which enters the circulation when
introduced into the body and so is able to have an active effect.
• EFFICACY - Efficacy is the capacity for beneficial change (or therapeutic effect) of a given
intervention (for example a drug, medical device, surgical procedure, or a public health intervention).
PHARMACOKINETICS AND PHARMACODYNAMICS
PHARMACOKINETICS PHARMACODYNAMICS
• Pharmacokinetics is the study of drug • Pharmacodynamics is the study of
absorption, distribution, and the biochemical and physiological
elimination (metabolisms and effect of a drug and their
excretion). mechanisms of action.
• Pharmacokinetics is “what the body • Pharmacodynamics is “what the drug
does to the drug”. does to the body”.
• Pharmacokinetics is the body’s action • Pharmacodynamics is the drug action
on the drug or alteration of a drug by on the body.
the body.
• ARM - Any of the treatment groups in a randomized trial.

CONTD … Most randomized trials have two “ arms, ” but some have
three “ arms, ” or even more.
• COHORT - In epidemiology, a group of individuals with
some characteristics in common.
• CROSS-OVER TRIAL - A type of clinical trial comparing
two or more interventions in which the participants, upon
completion of the course of one treatment, are switched to
another.
• CONTROL GROUP - The standard by which experimental
observations are evaluated. In many clinical trials one
group of patients will be given an experimental drug or
treatment, while the control group is given either a
standard treatment for the illness or a placebo.
• BLINDING – Blinding is a procedure in which one or more

BLINDING parties in a trial are kept unaware of which treatment arms
OR participants have been assigned to, in other words, which
treatment was received. Blinding is an important aspect of
MASKING any trial done in order to avoid and prevent conscious or
unconscious bias in the design and execution of a clinical
trial.
• SINGLE –BLIND STUDY - A study in which one party,
either the investigator or participant, is unaware of what
medication the participant is taking.
• DOBLE-BLIND STUDY - A clinical trial design in which
neither the participating individuals nor the study staff
knows which participants are receiving the experimental
drug and which are receiving a placebo (or another
therapy).
• SITE FEASIBILITY- It is a process to ensure that a proposed study has a

CONTD … greater probability of being successfully completed.
• PLACEBO - A placebo is an inactive pill, liquid, or powder that has no

treatment value. In clinical trials, experimental treatments are often
compared with placebos to assess the treatment's effectiveness. In some
studies, the participants in the control group will receive a placebo instead
of an active drug or treatment.
• ENDPOINT - Overall outcome that the protocol is designed to evaluate.
• FOOD AND DRUG ADMINISTRATION (FDA) - The US Department of

Health and Human Services agency responsible for ensuring the safety and
effectiveness of all drugs, biologics, and medical devices, including those
used in the diagnosis, treatment, and prevention of diseases.
BASELINE • The initial time point in a clinical trial, just before a

participant starts to receive the experimental
treatment which is being tested. At this reference
point, measurable values such as CD4 count are
recorded. Safety and efficacy of a drug are often
determined by monitoring changes from the
baseline values.
• An initial measurement that is taken at an early
time point to represent a beginning condition and
is used for comparison over time to look for
changes. For example, the size of a tumor will be
measured before treatment (baseline) and then
afterwards to see if the treatment had an effect.
ADVERSE EFFECT AND ADVERSE REACTION
ADVERSE EFFECT ADVERSE REACTION
An unwanted side effect of An unwanted effect caused by

treatment. the administration of drugs.
Onset may be sudden or
develop over time
ADVERSE EVENT
An AE is any untoward medical occurrence in a patient or clinical investigation

subject administered a pharmaceutical product and that does not necessarily have
a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign (including an

abnormal laboratory finding), symptom, or disease temporally associated with the
use of a medicinal (investigational) product, whether or not related to the
medicinal (investigational) product.
SERIOUS Any untoward medical occurrence that at any dose:

ADVERSE • Results in death
EVENT • Is life threatening, or places the participant at
immediate risk of death from the event as it
occurred
• Requires or prolongs hospitalization
• Causes persistent or significant disability or
incapacity
• Results in congenital anomalies or birth defects
UNEXPECTED • Unexpected: An adverse event or suspected

ADVERSE adverse reaction is considered "unexpected" if it
EVENT is not listed in the investigator brochure or is not
listed at the specificity or severity that has been
observed; or, if an investigator brochure is not
required or available, is not consistent with the
risk information described in the general
investigational plan or elsewhere in the current
application, as amended.
• Hepatic necrosis would be unexpected (by virtue
of greater severity) if the investigator brochure
only referred to elevated hepatic enzymes or
hepatitis.
SEVERTITY Refers to the intensity of the event and can be used with any
event
• Grade 1: Asymptomatic or mild symptoms
clinical or diagnostic observations only; no intervention indicated
• Grade 2: Moderate
minimal or noninvasive intervention indicated; limiting age-
appropriate instrumental ADL
• Grade 3: Severe
medically significant but not immediately life threatening;
hospitalization or prolongation of hospitalization indicated;
disabling
• Grade 4: Life-threatening
urgent intervention indicated
• Grade 5: Death related to an AE
INCLUSIUON AND EXCLUSION

CRITERIA
The medical or social standards determining whether a person may or may not be allowed to
enter a clinical trial. These criteria are based on such factors as age, gender, the type and
stage of a disease, previous treatment history, and other medical conditions.
INCLUSION EXCLUSION
• Inclusion criteria is a list of • Exclusion criteria is a list of
characteristics that qualify a person characteristics that disqualify a
from participating in a clinical trial. person from participating in a clinical
trial.
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INCLUSIUON
AND
EXCLUSION
CRITERIA
• CASE REPORT FORM - A case report form (or CRF) is a paper or electronic
questionnaire specifically used in clinical trial research. The case report
form is the tool used by the sponsor of the clinical trial to collect data from
each participating patient.
• Informed Consent Form - A process by which a participant or legal guardian

voluntarily confirms his or her willingness to participate in a particular trial,
after having been informed of all aspects of the trial that are relevant to the
participant’s decision to take part in the clinical trial. Informed consent is
CRF AND ICF usually documented by means of a written, signed, and dated informed
consent form, which has been approved by an IRB/IEC.
✓ A document that describes the rights of the study participants, and includes
details about the study, such as its purpose, duration, required procedures,
and key contacts. The main source of information to subjects considering
taking part in clinical trials is the Informed Consent Form (ICF). An ICF is a
document that requires a participant’s signature upon participating in a
clinical research study. The document gives detailed information about the
study the participant is considering and ensures the health care provider has
given complete information, including the risks and benefits of the study.
• Investigational new drug (IND) - A new drug, antibiotic

IND AND drug or biological drug, that is used in a clinical
NDA investigation. It also includes a biological product used in
vitro for diagnostic purposes.
• The term Investigational New Drug (IND) refers to a drug
developed by a pharmaceutical or biotech company or
other organization that is ready for clinical trials on
humans. When a drug reaches this point, the entity
submits an application known as Investigational New Drug
(IND) Applicaion to get the consent of the Food and Drug
Administration (FDA) to begin these trials.
• New drug application (NDA) - An application submitted
by the manufacturer of a drug to the FDA — after clinical
trials have been completed — for a license to market the
drug for a specified indication.
IRB/IEC …
• Institutional Review Board (IRB)/Independent Ethics Committee (IEC) – An
independent body constituted of medical, scientific, and nonscientific members
whose responsibility it is to ensure the protection of the rights, safety, and well-
being of human subjects involved in a trial by, among other things, reviewing,
approving, and providing continuing review of trials, protocols and amendments,
and of the methods and material to be used to obtaining and documenting
informed consent of the trial participant.
GCP AND RELATED TERMS …

Good Manufacturing Practice
(GMP) - Good manufacturing
GOOD CLINICAL PRACTICE (GCP)
practice (GMP) is a concept that
- GCP is an international ethical and
ensures products are consistently
scientific quality standard for
produced and controlled according to
designing, conducting, recording and
quality standards. It is designed to
reporting trials that involve the
minimize the risks to the patient
participation of human subjects.
involved in any pharmaceutical
production.
Current Good Manufacturing

GOOD LABORATORY PRACTICE
Practices (CGMPs) - CGMP refers
(GLP) - GLP is part of the quality
to the Current Good Manufacturing
assurance that ensures that
Practice regulations enforced by
organizations consistently produce
the FDA. CGMPs provide for
and control goods to a high-quality
systems that assure proper design,
standard. Good laboratory practice is
monitoring, and control of
not only concerned with
manufacturing processes and
production, but also quality control.
facilities.
CONTD …
Quality Control (QC) – The internal
Quality Assurance (QA) – operational techniques and activities
Systematic approach to ensure that undertaken within the quality
the data are generated, documented assurance system to verify that the
(recorded), and reported in requirements for quality of trial
compliance with the protocol and related activities have been fulfilled
good clinical practice (GCP) (e.g., data and form checks,
standards. monitoring by study staff, routine
reports, correction actions, etc.).
Recruitment Plan – The plan

that outlines how individuals Safety Monitoring Plan – A
will be recruited for the study plan that outlines the oversight
and how the study will reach of a clinical trial.
the recruitment goal.
CONTD …
Source Document – Original documents, data, and records (e.g., hospital records,
clinical and office charts, laboratory notes, memoranda, participant diaries, recorded
data from automated instruments, x-rays, etc.) that are used in a clinical trial.
Standard Operating Procedure (SOPs) – Detailed written instructions to achieve

uniformity of the performance of a specific function across studies and patients at an
individual site.
Outpatient - A person who receives treatment or participates in a study but is not

hospitalized overnight.
Recruitment Status
Not yet recruiting: The study has not started recruiting participants.
Recruiting: The study is currently recruiting participants.
Enrolling by invitation: The study is selecting its participants from a population, or group of
people, decided on by the researchers in advance. These studies are not open to everyone who
meets the eligibility criteria but only to people in that population, who are specifically invited to
participate.
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or
being examined, but potential participants are not currently being recruited or enrolled.
Suspended: The study has stopped early but may start again.
Terminated: The study has stopped early and will not start again. Participants are no longer
being examined or treated.
Completed: The study has ended normally, and participants are no longer being examined or
treated (that is, the last participant's last visit has occurred).
Withdrawn: The study stopped early, before enrolling its first participant.
Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet
recruiting; or active, not recruiting but that has passed its completion date, and the status has not
been last verified within the past 2 years.
• DOCUMENTATION - All records (including written documents,
electronic, magnetic or optical records, scans, x-rays etc.) that describe
or record the methods, conduct and results of the study, and the actions
taken. The Documents include Protocol, copies of submissions and
approvals from the office of the Drugs Controller General of India, ethics
committee, investigator(s)’ particulars, consent forms, monitor reports,
audit certificates, relevant letters, reference ranges, raw data, completed
CRFs and the final report.
CONTD … • ESSENTIAL DOCUMENTS - The Documents that permit evaluation of
the conduct of a study and the quality of the data generated.
• VALIDATION - The procedures carried out to ensure and prove that the
data contained in the final report match the original observations. The
procedure is applied to Raw Data, CRFs, computer software, printouts,
statistical analyses and consumption of Study Product / Comparator
Product.
SPONSOR - An individual or a company or an institution

that takes the responsibility for the initiation,
management and / or financing of a Clinical Study. An
Investigator who independently initiates and takes full
responsibility for a trial automatically assumes the role of
SPONSOR a Sponsor.
AND CRO …
CLINICAL RESEARCH ORGANISATION (CRO) - An
organisation to which the sponsor may transfer or
delegate some or all of the tasks, duties and / or
obligations regarding a Clinical Study. All such
contractual transfers of obligations should be defined in
writing. A CRO is a scientific body – commercial,
academic or other.
MONITOR - A person appointed by the Sponsor or Contract Research

Organisation (CRO) for monitoring and reporting the progress of the trial
and for verification of data. The monitor ensures that the trial is conducted,
recorded and reported in accordance with the Protocol, Standard Operating
Procedures (SOPs), Good Clinical Practice (GCP) and the applicable
regulatory requirements.
CONTD … CONTRACT - A written, dated and signed document describing the

agreement between two or more parties involved in a biomedical study,
namely Investigator, Sponsor, Institution. Typically, a contract sets out
delegation / distribution of responsibilities, financial arrangements and other
pertinent terms. The “Protocol” may form the basis of “Contract”.
INVESTIGATOR - A person responsible for the conduct of the study at the

trial site. Investigator is responsible for the rights, health and welfare of the
study subjects.
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ALCOA
PRINCIPLES
Attributable
Is it traceable to a person, date, and subject visit?
When documenting data on paper, every written element needs to be traced back to the
authorized individual who is responsible for recording it. This requires a signature or initials, the
date, and an identifier to a subject visit. Similarly, if something needs to be changed on the record,
it needs to be initialed, dated, and should explain the reason for the change.
Audit trails in an electronic system make it very obvious who created a record, when it was
created, who made a change, when the change was made, and the reason a change was made.
A compliant system will automatically track this information and enable electronic signatures.
ALCOA LEGIBLE - Is it clear enough to read?
• On paper, everything that’s written must be easy to read and recorded

PRINCIPLES in a permanent medium (not pencil). Handwriting must be clear to
reduce the likelihood of transcription errors and allow a study to be
accurately re-created.
CONTD … • Electronic source records typically solve the illegible handwriting

problem, because data and information are presented in a clean and
standardized format.
CONTEMPORANEOUS - Was it recorded as it happened?
• Data should be recorded, signed, and dated at the time of trial conduct,
rather than risk an individual recalling the wrong information from
memory. On paper, data needs to be documented in real-time and
dated with the current date (no predating or postdating).
• Automatic date and time stamps support this every time clinical data is
entered, edited, or modified in an electronic system that has the
appropriate controls in place to fully support compliance with 21 CFR
Part 11.
ALCOA ORIGINAL - Is it the first-place data is recorded?
• The source is the earliest record – the first place that data is
PRINCIPLES documented. If corrections or revisions need to be made,
changes shouldn’t obscure prior entries. Paper source
documents should be preserved and kept in their original
CONTD … form.
• When the first record is electronic, an audit trail can track any
and all subsequent queries and changes.
ACCURATE - Are all the details, correct?
• It’s critical that the source completely reflects the true

observations. This means an honest, accurate, and thorough
representation of facts describing the conduct of the study.
There will be times when source documents are incomplete,
inconsistent, or wrong. If changes need to be made, modifying
a paper record always need to be done in a compliant
manner.
Additional • ENDURING - Long-lasting and durable. Your
governing documents should be able to be accessed and

clearly read long after they are created.
body • AVAILABLE AND ACCESSIBLE - We’ve all been
standards not through monitoring visits where locating a file
covered in feels like a scavenger hunt. The EMA specifies
ALCOA-C that records should be easily available for review
of treating physicians and during
audits/inspections. The documents should be
retrievable in a reasonable time.
• CONSISTENT - Demonstrate the required
attributes consistently.
• CREDIBLE - Based on real and reliable facts.
AUDIT AND INSPECTION

AUDIT INSPECTION
• A systematic and independent • The act by a regulatory authority(ies) of
examination of trial-related activities conducting an official review of
and documents to determine whether documents, facilities, records, and any
the evaluated trial-related activities other resources that are deemed by
were conducted, and the data were the authority(ies) to be related to the
recorded, analyzed, and accurately clinical trial and that may be located at
reported according to the protocol, the site of the trial, at the sponsor's
sponsor's standard operating and/or contract research organization’s
procedures (SOPs), good clinical (CROs) facilities, or at other
practice (GCP), and the applicable establishments deemed appropriate by
regulatory requirement(s). the regulatory authority(ies).
CLINICAL DATA MANAGEMENT
• Clinical data management (CDM) is a critical process in clinical research,
which leads to generation of high-quality, reliable, and statistically sound data
from clinical trials. Clinical data management ensures collection, integration and
availability of data at appropriate quality and cost. It also supports the conduct,
management and analysis of studies across the spectrum of clinical research as
defined by the National Institutes of Health (NIH).
• The umtimate goal of CDM is to ensure that conclusions drawn from research
are well supported by the data. Achieving this goal protects public health and
confidence in marketed therapeutics.
CDISC • Clinical Data Interchange Standards Consortium (CDISC) – CDISC is an open,

non-profit organization that develops and supports global data standards to
STANDARDS
improve the quality and interoperability of medical research and healthcare. CDISC
standards are widely used for study planning and data collection, tabulation,
analysis, and submissions to the US Food and Drug Administration
(FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and
other regulatory agencies internationally.
• Study Data Tabulation Model (SDTM) - SDTM is an international standard for

clinical research data and is approved by the FDA as a standard electronic
submission format.
• Clinical Data Acquisition Standards Harmonization (CDASH) - CDASH

establishes a standard way to collect data consistently across studies and
sponsors so that data collection formats and structures provide clear traceability of
submission data into the Study Data Tabulation Model (SDTM), delivering more
transparency to regulators and others who conduct data review.
• Analytical Data Model (ADaM) - ADaM defines dataset and metadata standards
that support:
✓ 1. efficient generation, replication, and review of clinical trial statistical analyses,

and
✓ 2. traceability among analysis results, analysis data, and data represented in the
Study Data Tabulation Model (SDTM).
INVESTIGATOR’S • The Investigator’s Brochure (IB) is a compilation of the

BROCHURE clinical and nonclinical data on the investigational
product(s) that are relevant to the study of the product(s)
in human subjects.
• Its purpose is to provide the investigators and others
involved in the trial with the information to facilitate their
understanding of the rationale for, and their compliance
with, many key features of the protocol, such as the dose,
dose frequency/interval, methods of administration: and
safety monitoring procedures.
• Generally, the sponsor is responsible for ensuring that an
up-to-date IB is made available to the investigator(s) and
the investigators are responsible for providing the up-to-
date IB to the responsible IRBs/IECs.
• PROTOCOL - A document that states the background, objectives,

CDM rationale, design, methodology (including the methods for dealing
DOCUMENTS with AEs, withdrawals etc.) and statistical considerations of the study. It
also states the conditions under which the study shall be performed
and managed.
• DATA MANAGEMENT PLAN (DMP) - A data management

plan or DMP is a formal document that outlines how data are to be
handled both during a research project, and after the project is
completed. The goal of a data management plan is to consider the
many aspects of data management, metadata generation, data
preservation, and analysis before the project begins; this may lead to
data being well-managed in the present and prepared for preservation
in the future.
✓ A Data Management Plan (DMP) describes data that will be acquired or
produced during research; how the data will be managed, described,
and stored, what standards you will use, and how data will be handled
and protected during and after the completion of the project.
CDM • CRF Completion Guidelines - A CRF completion

DOCUMENTS guideline is a document to assist the investigator
to complete the CRF in a step-by-step
manner and is drafted concurrently in line with the
CRF and protocol.
• Annotated Case Report Form - Annotated

CRF’s document the location in a database of the
data collected for each question on a form. It’s a
mapping between each item on a form to its
corresponding variable contained within the
corresponding dataset.
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Important Definitions - CR and CDM

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Important Definitions - CR and CDM

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GLOSSARY OF

• Canada – Health Canada

• European Union - European Medicines Agency

Intervention – A procedure or treatment such as a drug,

• Diagnostic Research refers to the practice of looking for

TYPES OF RESEARCH STUDIES

Screening Research aims to find Quality of Life Research explores

Genetic studies aim to improve

Randomization - A method based on chance by which

Randomized trial - A study in which participants are

PHARMACOKINETICS AND PHARMACODYNAMICS

• ARM - Any of the treatment groups in a randomized trial.

• BLINDING – Blinding is a procedure in which one or more

• SITE FEASIBILITY- It is a process to ensure that a proposed study has a

• PLACEBO - A placebo is an inactive pill, liquid, or powder that has no

• ENDPOINT - Overall outcome that the protocol is designed to evaluate.

• FOOD AND DRUG ADMINISTRATION (FDA) - The US Department of

BASELINE • The initial time point in a clinical trial, just before a

ADVERSE EFFECT AND ADVERSE REACTION

ADVERSE EFFECT ADVERSE REACTION

An unwanted side effect of An unwanted effect caused by

An AE is any untoward medical occurrence in a patient or clinical investigation

An AE can therefore be any unfavorable and unintended sign (including an

SERIOUS Any untoward medical occurrence that at any dose:

UNEXPECTED • Unexpected: An adverse event or suspected

INCLUSIUON AND EXCLUSION

• Informed Consent Form - A process by which a participant or legal guardian

• Investigational new drug (IND) - A new drug, antibiotic

GCP AND RELATED TERMS …

Current Good Manufacturing

Recruitment Plan – The plan

Standard Operating Procedure (SOPs) – Detailed written instructions to achieve

Outpatient - A person who receives treatment or participates in a study but is not

SPONSOR - An individual or a company or an institution

MONITOR - A person appointed by the Sponsor or Contract Research

CONTD … CONTRACT - A written, dated and signed document describing the

INVESTIGATOR - A person responsible for the conduct of the study at the

Is it traceable to a person, date, and subject visit?

ALCOA LEGIBLE - Is it clear enough to read?

• On paper, everything that’s written must be easy to read and recorded

CONTD … • Electronic source records typically solve the illegible handwriting

ALCOA ORIGINAL - Is it the first-place data is recorded?

• It’s critical that the source completely reflects the true

Additional • ENDURING - Long-lasting and durable. Your

governing documents should be able to be accessed and

AUDIT AND INSPECTION

CDISC • Clinical Data Interchange Standards Consortium (CDISC) – CDISC is an open,

• Study Data Tabulation Model (SDTM) - SDTM is an international standard for

• Clinical Data Acquisition Standards Harmonization (CDASH) - CDASH

✓ 1. efficient generation, replication, and review of clinical trial statistical analyses,

INVESTIGATOR’S • The Investigator’s Brochure (IB) is a compilation of the

• PROTOCOL - A document that states the background, objectives,

• DATA MANAGEMENT PLAN (DMP) - A data management

CDM • CRF Completion Guidelines - A CRF completion

• Annotated Case Report Form - Annotated

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