To be internationally recognised as the premier organisation for clinical research respected as a

key influencer, promoting knowledge and understanding by engaging the healthcare community
and the general public.
The Institute of Clinical Research
Thames House, Mere Park, Dedmere Road, Marlow, Buckinghamshire SL7 1PB
info@instituteofclinicalresearch.org
www.instituteofclinicalresearch.org
Telephone: 01628 899755
Facsimile: 01628 899766

Disclaimer: The opinions expressed in this publication are those of the subcommittee, and not
necessarily those of The Institute of Clinical Research
All rights reserved.
No parts of this book may be reproduced by any means or transmitted, or translated into
machine language without written permission of the publisher.
ISBN 0-9549345-4-7
Designed by Stretton Graphics 01628 828222
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The leading organisation

for clinical research
professionals
Internationally recognised as the premier organisation for
clinical research, respected as a key influencer, promoting
knowledge and understanding by engaging the healthcare
community and the general public.

raising standards
sharing knowledge
developing professionals

Raising standards
The Institutes professional standards encourage our members to work to the highest standards,
enhancing the standards of clinical research and maintaining the professional identity of members
The Institute recognises the academic achievement and clinical research experience by awarding
designatory letters e.g. MICR to our members.

Sharing knowledge
The Institute offers a comprehensive range of Information Services and publications, including our journal
Clinical Research focus, our publications, online resources, a resource centre and membership helpline.

Developing professionals
The Institute provides educational courses and training workshops, continuing professional
development, academic qualifications and accreditation of training courses. All of these enhance the
professional competence of our members.

For more information call +44 1628 899755

or visit www.instituteofclinicalresearch.org

Acknowledgement
Grateful thanks are extended to members of the CRA Subcommittee past and present for
their input.

Is this you or could this be you?

Are you:
Logical, Methodical and Organised?
Approachable, friendly whilst being firm?
Do you:
Enjoy meeting new people?
Enjoy travelling?
Working both as part of a team, and independently?
If so, then read on as a career in clinical research as a Clinical Research Associate
(CRA) could be for you!
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Contents
Acknowledgement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Is this you or could this be you? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
The Clinical Research Associate (CRA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Role and Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Table 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Education and Training Opportunities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Qualifications, Experience and Skills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Qualifications: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Experience: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Essential Skills of a CRA include: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Career Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
CRA Level I: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
CRA Level II: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
CRA Level III or Senior CRA: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
How do I find a CRA Position? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
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The Institute of Clinical Research CRA Subcommittee. . . . . . . . . . . . . . . . . 15

Would you like to find out more? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Drug Research and Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Phases of Clinical Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Organising a Clinical Trial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Organisations and Websites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

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Introduction
An important objective of clinical research is to ensure that marketed drugs are as safe
and effective as possible. When a promising drug is discovered, a pharmaceutical company
will plan a clinical development programme involving several phases of clinical research.
Each phase will involve at least one clinical trial or trial, sponsored by the pharmaceutical
company responsible for the drug to be tested.
CRAs are involved in all phases of clinical research and at all stages of a particular trial.
Therefore, possible CRA duties include most of the activities required to set up, monitor
and complete a clinical trial. A new CRA is most likely to be involved in the initiation,
monitoring and close-out of a selected group of investigational sites.
Recruitment of CRAs may be directly into a pharmaceutical company or into a Contract
Research Organisation (CRO) which can plan, organise and/or conduct clinical trials on
behalf of pharmaceutical companies.
This booklet aims to provide ideas, information and guidance to those who might be
interested in becoming a CRA, either within the Pharmaceutical Industry or within the
Pharmaceutical Service Industry. Existing CRAs and colleagues may wish to give this booklet
to those who express an interest in the CRA role. Careers Advisors, recruitment and Human
Resources may wish to use this booklet to provide information, in a concise and relevant
form, to those actively seeking a CRA position.

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The Clinical Research Associate (CRA)

Definition
Clinical Research Associates are research professionals carrying out activities that may
include investigational site selection, set up, initiation, monitoring and close-out, and can be
involved in all operational aspects of the clinical phases of drug development.

Role and Functions

Clinical Research Associates are also known as CRAs, Clinical Research Monitors, Clinical Trial
Monitors, Clinical Research Scientists etc. and the titles used vary from company to company.
CRAs can be full-time or part-time and based in the field (home based) or in the office, either
at the Sponsor/CRO office or at the investigational site. It is quite common to work on 6 -12
month contracts with a company rather than as a permanent employee. Some CRAs therefore
choose to work freelance for a variety of clients once they have gained enough experience.
They may be involved in all phases of clinical research and at all stages of a particular trial,
within a variety of therapeutic areas. Although the role and functions of CRAs will vary slightly
from company to company, it is likely that a CRA will be involved in all activities required to set
up, conduct and complete a clinical trial, including:
Investigator identification and selection.
Co-ordination of ethics committee and regulatory authority applications and approvals.
Pre trial procedures including collation of necessary documentation. This usually involves a
visit to the investigational site to assess their suitability to conduct the trial.
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Organisation, attendance and/or presentations at investigator meetings.

Initiation, monitoring and close-out of investigational sites (see Table 1).
Training of site staff to trial specific and industry standards.
Supervision and/or distribution of trial supplies, including the trial drug (investigational
medicinal product).
Protocol and Case Report Form (CRF) development.
Archiving of trial documentation and correspondence.
Clinical Trial Report and manuscript for publication (occasional).

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Table 1
Initiation:

Monitoring
visit:

Close-out
visit:

To be a CRA

This is the visit to the investigational site at the very beginning of the trial that
is carried out once all the appropriate approvals and paperwork are in place.
This involves meeting with all the appropriate departments/site staff within the
investigational site (e.g. pharmacy, laboratories, radiology etc) This is to ensure
that they are aware of the trial protocol, procedures, ICH GCP and the logistical
aspects of running the trial, to name a few. This can involve speaking one to
one, or speaking in front of a group about the trial.
These usually take place over one to two days at the investigational site
approximately every four to six weeks depending on the trial, therapeutic area
and the number of subjects taking part. Regular monitoring visits are made by a
CRA to verify (SDV) and collect data recorded on CRFs, ensure prompt reporting
of adverse events, maintain drug accountability, ensure adherence to the trial
protocol, Good Clinical Practice (GCP) and Standard Operating Procedures
(SOPs), encourage further subject recruitment, identify and resolve problems.
This is the very last visit that is made to an investigational site at the end of the
trial once all subjects have finished the trial and the database has been cleaned
by data management. This will involve ensuring that 100% Investigational
Medicinal Product (IMP) accountability, checking all the paperwork is in place
and that any remaining trial supplies have been removed/destroyed. This
meeting will always involve a final discussion with the investigator at the
investigational site to remind them of their responsibilities for archiving and
retaining the trial documents according to ICH GCP.

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Education and Training Opportunities

Pharmaceutical companies and CROs provide on-the-job training plus, in some cases,
a structured system of internal training courses and access to external training courses.
Wide experience is gained by working in different phases of clinical research and different
therapeutic areas.
External training courses available include:
The Institute of Clinical Research offers one day courses such as So you want to be a
CRA?, Introduction to Clinical Research, The Proactive CRA.
Formal academic qualifications such as a PgCert, a Diploma, an MSc and PhD in Clinical
Research are available through the Institute and Cranfield University. There are also other
suppliers who will be found on the Institute website from autumn 05.
There are training programmes for graduates to become CRAs in a combined
environment of training and job placements. ICR is about to launch a Resourcing Forum
and later in 2005 the ICR website will list all the suppliers with web links for those
interested in comparing opportunities. Contact ICR for the latest information.

Qualifications, Experience and Skills

Qualifications:

Most CRA positions require as a minimum a BSc in biological/life sciences, pharmacy,

chemistry or related medical field or a nursing qualification.

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Experience:

To get your first job it is essential to do your homework and have knowledge of:
The pharmaceutical and services industry.
The job role itself and what it might entail.
The industry regulations that must be followed (e.g. International Conference on
Harmonisation for Good Clinical Practice (ICH GCP), EU Clinical Trials Directive (2001/20/EC),
EU Directive on GCP (2005/28/EC).
Demonstrate an understanding of the travelling that can be involved in a CRA role.

Essential Skills of a CRA include:

Organisational skills (including multi-tasking).

Methodical and meticulous nature with attention to detail.
Administrative and writing skills.
Time management.
Communication skills.
Interpersonal skills.
Diplomacy.
Ability to motivate and organise others.
Flexibility and versatility.
IT skills.

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Career Development
The CRA role is varied and the career development can vary from company to company.
Some CRAs begin their career in data management or as Clinical Trial Administrators (CTAs)
before gaining a Junior CRA position. Others may have gained a background in areas
involving pre-clinical research.
The Institute of Clinical Research offers members an active continuous professional
development (CPD) scheme, which is strongly encouraged when you are looking for a
career as a CRA and during your career to improve your skills and expertise.
A guidance of the career path as a CRA is given below.

CRA Level I:

Functions may include:

Pre-trial procedures including collation of necessary documentation to start a trial.
Initiation, monitoring and close-out of investigational sites, usually accompanied by a
more experienced CRA for the first few months. (see Table 1)
Archiving of trial documentation and correspondence.

CRA Level II:

Role

Investigator identification and selection.

Co-ordination of ethics committee and regulatory authority applications and approvals.

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 Supervision and/or distribution of trial supplies, including the trial drug (investigational
medicinal product).
Organisation, attendance and/or presentations at investigator meetings.

CRA Level III or Senior CRA:

This more senior role may cover any of the above tasks but may also include supervising,
training and mentoring junior members of staff, and project management of whole trials
within a country/internationally. You may also get involved in protocol and Case Report
Form (CRF) development and other medical writing projects.

How do I find a CRA Position?

Positions can be found via:
Advertisements in journals such as Clinical Research focus (the journal of The Institute
of Clinical Research).
Internet searches.
Recruitment Agencies.
Recruitment Fairs.
Contacts within the contract research or pharmaceutical industries.
Speculative application to pharmaceutical or contract research companies.
Internal moves from other positions within the same company.

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The Institute of Clinical Research

CRA Subcommittee
The CRA Subcommittee comprises of volunteers from pharmaceutical companies, CROs and
investigational sites. Since it was established in 2004, the CRA Subcommittee has focused
on defining and promoting the role of the CRA across clinical research both within the UK
and worldwide. Anyone wishing to find out more about the CRA subcommittee, or wishing
to join, please contact The Institute of Clinical Research.

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Would you like to find out more?

Below is a brief overview of the drug research and development process.

Drug Research and Development

The objectives of drug research and development include the production of safe,
effective and profitable drugs of high quality for use by the medical profession. The cost
of developing a new substance into a licensed medicine is huge (approximately 360
million) and can take between 10 and 12 years. The risk of early failure is great; only 1
new compound in 10,000 discovered will reach the stage where a marketing license is
approved. Costs and risks must be covered by sales of the new drug and other drugs in a
companys portfolio.
The pharmaceutical industry is strictly regulated, with laws limiting prices, profit
margins and promotion of products. Regulatory authorities keep a watchful eye on
research and on the marketing of new and existing drugs. International research and
marketing are also controlled by the authorities in other countries, e.g. the Food and
Drug Administration (FDA) in the USA and the European Medicines Evaluation Agency
(EMEA) in Europe. In Europe, EFPIA (the European Federation of Pharmaceutical Industries
Association) represents the manufacturers of prescription medicines and provides internal
regulation of the industry. In the UK this role is played by the ABPI (Association of British
Pharmaceutical Industry).

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Phases of Clinical Research

An important objective of clinical research is to ensure that marketed drugs are safe and
effective. All drugs have side-effects, many of which are undesirable. Some drugs carry a risk
of toxic effects. It is important to weigh up the risk to benefit ratio. Unwanted side-effects
and a risk of toxicity may be acceptable for a drug used to treat serious, life-threatening
diseases such as cancer. The same unwanted effects and risks would be unacceptable to
subjects, and therefore to the regulatory authorities, if the drug were to be used to treat a
minor illness. Women who are pregnant or lactating, or who are likely to become pregnant,
are excluded from most clinical research, so as to avoid the risk of any unknown effects on
the child. A pharmaceutical company will take care to plan a clinical research strategy for a
new drug, so as to minimise the time and cost of obtaining a Product License. The strategy
may involve several phases of clinical research, with at least one trial within each phase:
Pre-Clinical Research
Prior to initial use in trial subjects, potential new medicines are tested exhaustively
to assess mode of action, potential therapeutic benefit and toxic effects at a range of
doses. Information is gathered on the absorption, distribution, metabolism and excretion
of the compound.
Phase I (Human Pharmacology) trials involve the first exposure of a new active
compound or new formulation to human subjects. Trials are designed to make a preliminary
assessment of safety, pharmacokinetics and pharmacodynamics. Trial subjects are usually
healthy volunteers, often young males.
Phase II (Therapeutic Exploratory) trials are therapeutic, assessing efficacy and safety
in a small number of subjects with the relevant illness or condition. Entry criteria are very
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strict and limited so as to ensure a well-defined trial population. Here the aims are to
demonstrate a proof of concept.
Phase III (Therapeutic Confirmatory) trials assess short- and long-term safety and
efficacy in larger numbers of subjects. Entry criteria are well defined but may be less
limiting than in Phase II. Trials usually involve a placebo and/or a competitor drug for
comparison, with blinded randomisation of treatment allocation. These trials usually
provide the pivotal data needed for a Marketing Authorisation Application.
Phase IV (Therapeutic Use) trials are conducted after the Marketing Authorisation
Application has been granted and often coincide with the launch of the new drug onto the
market. Trials involve large number of subjects; the entry criteria are less limiting so as to
encompass a broad selection of subjects. Trials are usually comparative with a competitor
drug or occasionally placebo control. The aim is to provide more safety and efficacy
information and sometimes to change or expand the indication for use so as to increase
market share.
Post Marketing Surveillance (PMS) trials involve very large number of subjects from a
diverse general population. Important information is collected on subjects to whom the
drug is administered. The aim is to continue the monitoring of drug safety and to highlight
any rare side-effects which might only come to light after large scale use.

Organising a Clinical Trial

Once a company has decided on the type of trial required, a trial protocol will be drafted
with input from regulatory experts, clinical research personnel, physicians, statisticians
and biometricians. A steering committee may be set up to decide on the best trial design
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to provide the necessary information. The trial design may be single-blind or double-blind,
with a placebo or active control and parallel or cross-over treatment.
The content of the final protocol will be mirrored in the design of the Case Report Forms
(CRFs), used by investigators to record the subject data collected during the trial. The
protocol and CRF and any later amendments are put through rigorous internal and external
approval processes.
Investigator sites are carefully chosen and briefed to ensure that each has adequate
facilities and enough staff, time and enthusiasm to carry out the trial procedures correctly.
The surgery list or hospital population must be such that suitable subjects can be recruited
at an acceptable rate. Each site must be provided with adequate trial supplies, including the
trial drug and any comparators with correct labeling and procedures for maintaining any
blinding and ensuring accurate accountability.
The clinical research industry is controlled by strict ethical restrictions. Since 1st May 2004,
the ethics process has undergone major structural and operational changes, to bring the
processes into line with the EU Directive 2001/20/EC. All potential clinical trials must be
approved by a research ethics committee (REC) before participants can be recruited into
the trial. Audits are often performed by Quality Assurance personnel from the sponsor and/
or contract organisation. Trials can also be inspected by the Regulatory Authority at any
time before or after a Marketing Authorisation Application has been made. A Regulatory
Authority inspection can also take place after the trial has finished and all documents have
been archived.

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Conclusions
If you are enthusiastic, logical, methodical and looking for career variety then the CRA role
may offer you a career opportunity within the clinical research industry.
It is hoped that this booklet has helped clarifying the role and responsibilities of the CRA. If
this could be you and you would like to find more information than what is provided in this
booklet, or you wish to become a member of The Institute of Clinical Research, please visit
the website of The Institute of Clinical Research: http://www.instituteofclinicalresearch.org.

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Organisations and Websites

ICR The Institute of Clinical Research
http://www.instituteofclinicalresearch.org/
ABPI Association of the British Pharmaceutical Industry:
http://www.abpi.org.uk/
ACDM Association of Clinical Data Management
http://www.acdm.org.uk/
BARQA British Association of Research Quality Assurance.
http://www.barqa.com/
COREC Central Office for Research Ethics committees
http://www.corec.org.uk/
EFPIA The European Federation of Pharmaceutical Industries and Associations
http://www.efpia.org/
EMEA The European Medicines Agency
http://www.emea.eu.int/
EUDRA European Commission DG and Enterprise
http://pharmacos.eudra.org/F2/home.html
Eur-Lex European Union legislation
http://europa.eu.int/eur-lex/en/search/search_lif.html
MRC Medical Research Council
http://www.mrc.ac.uk/
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MHRA Medicines and Healthcare products Regulatory Agency

http://www.mhra.gov.uk/
NHS R&D Department of Health Research & Development
http://www.dh.gov.uk/PolicyAndGuidance/ResearchAndDevelopment/fs/en
TOPRA The Organisation for Professionals in Regulatory Affairs
http://www.topra.org/Resource.phx/public/start.htx

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References
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on
the approximation of the laws, regulations and administrative provisions of the Member
States relating to the implementation of good clinical practice in the conduct of clinical
trials on medicinal products for human use. Official Journal of the European Communities
L121/34-44
Commission Directive 2005/28/EC on the laying down principles and detailed guidelines
for good clinical practice as regards investigational medicinal products for human use, as
well as the requirements for authorisation of the manufacturing or importation of such
products. European Commission, 2005. Official Journal of the European Communities
L91/13-19
ICH Harmonised Tripartite Guideline for Good Clinical Practice, ICH Secretariat, 1996
World Medical Association Declaration of Helsinki Ethical Principles for Medical Research
Involving Human Subjects, South Africa, 1996.
World Medical Association Declaration of Helsinki Ethical Principles for Medical Research
Involving Human Subjects, Edinburgh, 2000.
World Health Organisation, No. 850, Annex 3, WHO Technical Report Series: Guidelines for
Good Clinical Practice (GCP) for Trials on Pharmaceutical Products, WHO, 1993

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Glossary
Active control

An active, as opposed to dummy, treatment allocated to one group of subjects to act as a

reference for comparison with the trial drug.

Adverse event

Any untoward medical occurrence in a subject or clinical investigation subject administered

a pharmaceutical product and which does not necessarily have a causal relationship with
this treatment. An adverse event (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.

Archiving

The long term storage and retrieval of trial documentation.

Audit

A systematic and independent examination of trial related activities and documents to

determine whether the evaluated trial related activities were conducted, and the data
were recorded, analysed and accurately reported according to the protocol, sponsors
standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable
regulatory requirement(s).

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Case Report Form (CRF)

A printed or electronic document designed to record all of the information required by the
protocol to be reported to the sponsor on each trial subject.

Centre (or Site)

The location(s) where the trial-related activities are actually conducted. Trials may be at one
site or multisite.

Comparator trial

A trial in which subjects are allocated to more than one alternative active treatment and
the alternatives are then compared.

Competitor drug

An alternate treatment, which is used for the same indication as that proposed for the trial
drug and would therefore, compete for market share.

Clinical Trial Application (CTA)

The application form for applying for regulatory approval, required prior to the start of any
trial, in line with the EU Directive

Clinical Trial Administrator (CTA)

Someone who administers, maintains and co-ordinates the logistical aspects of clinical
trials according to Good Clinical Practice and relevant SOPs and acts as a pivotal point of
contact for the clinical trial team

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Clinical Research

Clinical research is the design, management, conduct and reporting of an evaluation of

the impact of a therapeutic intervention. Clinical research aims to specifically answer a
question about treating a disease through human participation, records based trials, clinical
samples or in technology development for clinical use. It conducts the research, within the
confines of current legislation and medical ethics, according to good clinical practice.
Human participation: trials which require the intervention to be tested using direct contact
with human participants (clinical trial).
Records based trials: require access to personal data on health or lifestyle without direct
contact (health economic trials or health services research).
Clinical samples: trials which involve laboratory trials on human material.
Technology development for clinical use: instrument development for diagnostic or surgical
use or new techniques.

Clinical Research Associate

Clinical Research Associates are research professionals carrying out activities that may
include investigational site selection, set up, initiation, monitoring and close-out, and can
be involved in all operational aspects of the clinical phases of drug development

Clinical Research Organisation (CRO)

A person or an organisation (commercial, academic or other) contracted by the sponsor to

perform one or more of a sponsors trial related duties and functions.

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Clinical Trial

A type of research trial that tests an investigational new drug or method to see how well it
works on people.

Continuous Professional Development (CPD)

The planned acquisition of knowledge, experience and skills and the development of
personal qualities for the execution of professional duties and for career management
throughout working life.

Cross-over trial

A trial in which subjects receive one treatment followed by another, the treatments often
being separated by a washout period when the subjects receive no treatment or placebo.

Data management

All procedures for handling and processing data collected during a trial.

Double-blind

A system to ensure that the treatment allocated is unknown to both theinvestigator and
the subject.

Entry criteria

Rules to ensure that suitable subjects are selected for entry into a trial. Inclusion criteria
describe subjects who are suitable in terms of age, sex, disease. Exclusion criteria describe
subjects who should not be selected, so as to avoid various health risks and to maximise
the validity of the trial results.

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Generic

The non-branded compound and name by which it is commonly known.

Genetic engineering

The science, which, includes the mass production of useful biological substances by
modification and transplant of genetic material.

Good Clinical Practice (GCP)

A standard for the design, conduct performance, monitoring auditing recording analyses
and reporting of clinical trials that provides assurance that the data and reported results
are credible and accurate and that the rights, integrity and confidentiality of trial subjects
are protected.

Institute of Clinical Research, The (ICR)

The premier organisation for professionals in all aspects of clinical research.

International Conference on Harmonisation (ICH)

The ICH GCP guideline was developed to provide a unified standard for the European Union,
Japan and United States, as well as those of Australia, Canada, the Nordic countries and the
World Health Organisation (WHO).

Indication

The condition or disease for which a licensed or trial treatment is to be used.

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Informed consent

A process by which a subject 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
subjects decision to participate. Informed consent is documented by means of a written,
signed and dated informed consent form.

Investigational Medicinal Product (IMP)

A pharmaceutical form of an active ingredient or placebo being tested or used as a

reference in a clinical trial, including a product with a marketing authorisation when used
or assembled in a way different from the approved form, or when used for an unapproved
indication, or when used to gain further information about an approved use.

Investigator

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted
by a team of individuals at a trial site, the investigator is the responsible leader of the team
and may be called the principal investigator.

Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted,
recorded, and reported in accordance with the protocol, Standard Operating Procedures
(SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

New Chemical Entity

A newly developed compound.

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Parallel trial

A trial in which two or more separate groups of subjects are used to compare two or more
treatments; each group receives a different, single treatment, usually allocated randomly.

Patent protection

The exclusive right to produce a particular compound or formulation, such that no other
company can produce a copy.

Pharmacology

The trial of drugs.

Pharmacodynamics

The effects of a drug on the physiology of the body.

Pharmacokinetics

The trial of Absorption, Distribution, Metabolism and Excretion (ADME) of drugs when
administered to humans or animals.

Pivotal trial

A trial conducted to GCP Guidelines and providing crucial efficacy and safety data to
Regulatory Authorities.

Placebo

An inactive substance, usually formulated to be identical to the trial treatment, used to

provide reference data, which controls psychosomatic effects and designed to minimise
investigator and/or subject bias towards a treatment.

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Product License

Regulatory approval needed to market, advertise, sell and supply medicinal products.

Protocol

A document that describes the objective(s), design, methodology, statistical considerations,

and organisation of a trial. The protocol usually also gives the background and rationale for
the trial, but these could be provided in other protocol referenced documents.

Randomisation

The unpredictable allocation of subjects to different treatments to minimise the possibility

of bias.

Receptors

Chemical groupings/molecular structures, within or on the surface of a body cell, to

which other specific chemical groupings/molecular structures can attach to produce a
particular effect.

Safety/Tolerability

A lack of adverse events, serious events, toxicity associated with a treatment.

Shelf life

The period for which a product is confirmed as being fit for its purpose.

Side-effects

Effects other than those intended to treat the indication.

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Single-blind

A system to ensure that the treatment allocated is unknown to the subject. In this case the
investigator does know which treatment the subject is taking.

Source Data Verification (SDV)

Verifying that all information in original records and certified copies of original records of
clinical findings, observations, or other activities in a clinical trial are accurately reported in
the Case Report Form (CRF).

Sponsor

An individual, company, institution, or organisation which takes responsibility for the

initiation, management, and/or financing of a clinical trial.

Standard Operating Procedure

A detailed written description of how a unit executes a particular procedure or method.

It is intended to standardize the performance of the procedure. Comprehensive and
controlled documents, generally covered under the companys quality system and thus
kept fully up to date.

Steering committee

A group of medical and research experts, who review, discuss and advise on the
development of the trial protocol and/or aspects of the ongoing trial.

Subject

A subject is an individual who participates in a clinical trial who could be a healthy

volunteer or a patient being treated in a GP surgery or hospital.

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Toxicology

The trial of poisonous effects of chemicals on the body.

Trial Master File (TMF)

The file (s) containing all the essential documentation for a trial.

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About ICR Publishing

The Institute of Clinical Research (ICR)
is committed to developing information
resources, and encouraging information
sharing, amongst the profession and related
areas in research and development. ICR
Publishing produces the ICR Reports, booklets
and the Monograph series. Our publications
are written by key people in the field who
want to share their knowledge with others
involved in research and development.

About the publications

The ICR is responsible for publishing a wide
range of material:
The Monograph series offers in depth
information on issues in clinical research
Smaller booklets providing advice on
careers, roles and regulations in the industry
The ICR Reports, which are available free
to download from the website. These
reports offer up to date guidance on
issues to anyone interested in this sector

About The Institute

of Clinical Research

ICR has been in existence since 1978 and our

vision is To be internationally recognised as
the premier organisation for clinical research,
respected as a key influencer, promoting
knowledge and understanding by engaging the
healthcare community and the general public.
www.instituteofclinicalresearch.org