Clinical Research
Clinical Research
Clinical Research
HANDBOOK
FOR GOOD
CLINICAL
RESEARCH
PRACTICE
(GCP)
GUIDANCE FOR
IMPLEMENTATION
ISBN 92 4 159392 X
WHO
HANDBOOK
FOR GOOD
CLINICAL
RESEARCH
PRACTICE
(GCP)
GUIDANCE FOR
IMPLEMENTATION
WHO Library Cataloguing-in-Publication Data
Preamble 1
Introduction 3
Overview of the Clinical Research Process 8
WHO Principles of GCP 19
Principle 1: Ethical Conduct 21
Principle 2: Research described in a protocol 27
Principle 3: Risk Identification 35
Principle 4: Benefit-Risk Assessment 42
Principle 5: Review by Independent Ethics Committee/
Independent Review Board 48
Principle 6: Protocol Compliance 54
Principle 7: Informed Consent 59
Principle 8: Continuing Review/Ongoing Benefit-Risk
Assessment 72
Principle 9: Investigator Qualifications 82
Principle 10: Staff Qualifications 87
Principle 11: Records 92
Principle 12: Confidentiality/Privacy 103
Principle 13: Good Manufacturing Practice 110
Principle 14: Quality Systems 115
References: 121
Documents on CD 121
Other documents cited in the Handbook 122
Related documents 123
National Good Clinical Practice and Other Guidelines 124
Acknowledgements 125
| iii
Preamble
1
These trials assign trial subjects to treatment or control groups using an element of
chance to determine the assignments in order to reduce bias.
| 1
• explaining each GCP Principle and providing guidance on how each
Principle is routinely applied and implemented;
Background
For the purposes of this handbook, a general definition of human
research is:
| 3
to undue risks.” (World Health Organization, Governance, rules and
procedures, WHO Manual XVII).
In the early 1960s, widespread concern about the safety and control
of investigational drugs and the clinical research process developed
among members of the medical profession, the scientific commu-
nity, regulatory authorities, and the general public. In 1968, WHO
convened a Scientific Group on Principles for Clinical Evaluation of
Drugs. The Scientific Group was charged with reviewing and formu-
lating principles for clinical evaluation of drug products, whether new
or already marketed, including considerations for new indications or
dosage forms for marketed products and new combination products.
In 1975, another WHO Scientific Group was convened to specifically
consider all aspects of the evaluation and testing of drugs and to for-
mulate proposals and guidelines for research in the field of drug de-
velopment. These reports formed the basis for WHO’s “Guidelines for
good clinical practice (GCP) for trials on pharmaceutical products”,
published in 1995, as well as many national and international guide-
lines that have subsequently been developed, including:
I N T RO DU C T I O N | 5
• to assist editors in evaluating the acceptability of reported research
for publication, and regulators in evaluating the acceptability of
any study that could affect the use or the terms of registration of a
medical product.
Although some principles of GCP may not apply to all types of re-
search on human subjects, consideration of these principles is
strongly encouraged wherever applicable as a means of ensuring
the ethical, methodologically sound and accurate conduct of human
subjects’ research.
I N T RO DU C T I O N | 7
Overview of the clinical
research process
8 |
Institutional Review Boards [IECs/IRBs] monitors, contract research
organizations [CROs]) should develop and follow written standard op-
erating procedures (SOPs) that define responsibilities, records, and
methods to be used for study-related activities.
• investigator’s brochure;
• case report forms (CRFs) for each scheduled study visit to capture
all of the necessary data collected from and reported for each sub-
ject;
• formats for progress reports, annual reports, and final study re-
ports.
See WHO GCP Principles 2: Protocol; 11: Records; 13: Good Manufac-
turing Practice; 14: Quality Systems
• data acquisition;
• database closure;
• database validation;
• data quality measurement (i.e. how reliable are the data) and qual-
ity assurance;
• a reference list.
See WHO GCP Principles 2: Protocol; 11: Records; see also ICH E3
(Structure and Content of Clinical Study Reports)
Application
Principle 1 is applied through:
• informed consent;
“Respect for persons requires that subjects, to the degree that they
are capable, be given the opportunity to choose what shall or shall
not happen to them. This opportunity is provided when adequate
standards for informed consent are satisfied.” (The Belmont Report)
Within GCP, the principle of “respect for persons” is most directly im-
plemented through the process of informed consent. Included here
is the provision that the subject (or subject’s legally authorized repre-
sentative) will be informed in a timely manner if information becomes
available that may be relevant to the subject’s willingness to continue
participation in the trial. (See WHO GCP Principle 7: Informed Consent)
Implementation
The basic ethical principles of biomedical research are reflected in
all GCP principles and processes, impacting on the role and respon-
sibilities of each party within GCP. Each party participating in clinical
research has responsibility for ensuring that research is ethically and
scientifically conducted according to the highest standards. This in-
cludes the investigator(s) and site staff, the sponsor and sponsor’s
staff (including monitors and auditors), the ethics committee(s), the
regulatory authority(-ies), and the individual research subjects.
See also:
Definitions for:
Impartial Witness (ICH E6, 1.26)
Informed Consent (ICH E6, 1.28)
Application
Principle 2 is applied through development of a clear, detailed, scien-
tifically justified and ethically sound protocol that (1) complies with
requirements established by national and local laws and regulations,
and (2) undergoes scientific and ethical review prior to implementa-
tion.
• general information;
• background information;
• treatment information;
1
In this document, “regional” refers to supranational laws, regulations, or require-
ments, such as those adopted by the European Union.
Implementation
Sponsors are primarily responsible for (1) designing the clinical
investigation, (2) developing the study protocol, investigator’s bro-
chure, and related materials to describe the procedures that will be
followed, study endpoints, data collection, and other study require-
See also:
Definitions for:
Investigator’s Brochure (ICH E6, 1.36)
Protocol (ICH E6, 1.44)
Protocol Amendment (ICH E6, 1.45)
Application
Principle 3 is applied through:
Implementation
The responsibility for implementing this principle is shared by spon-
sors, investigators, IECs/IRBs, and regulators:
See also:
Definitions for:
Investigator’s Brochure (ICH E6, 1.36)
Nonclinical Study (ICH E6, 1.41)
Protocol (ICH E6, 1.44)
Protocol Amendment (ICH E6, 1.45)
“It is commonly said that benefits and risks must be ‘balanced’ and
shown to be ‘in a favourable ratio.’ … Thus, there should first be a
determination of the validity of the presuppositions of the research;
then the nature, probability and magnitude of risk should be distin-
guished with as much clarity as possible. The method of ascertain-
ing risks should be explicit … It should also be determined whether
… estimates of the probability of harm or benefits are reasonable,
as judged by known facts or other available studies.” (The Belmont
Report)
“… Scientific review must consider inter alia, the study design, in-
cluding the provisions for avoiding or minimizing risk and for monitor-
ing safety.” (CIOMS, International Ethical Guidelines, Commentary on
Guideline 2)
Application
Principle 4 is applied through appropriate study design and through
ethical, scientific, and, where applicable, regulatory review of the
study protocol prior to study initiation.
Implementation
The responsibility for implementing this principle is shared by spon-
sors, investigators, IECs/IRBs, and regulators.
See also:
Application
Principle 5 is applied through protocol review by an IEC/IRB that is
constituted and operating in accordance with GCP and applicable
national/local laws and regulations.
Review by the IEC/IRB also helps ensure that the research is evaluat-
ed by a party that is independent of the trial. “The review committees
must be independent of the research team, and any direct financial
or other material benefit they may derive from the research should
not be contingent on the outcome of their review.” (CIOMS, Interna-
tional Ethical Guidelines, Guideline 2)
See also:
Definitions for:
Approval (in relation to institutional review boards (IRBs)) (ICH E6, 1.5)
Independent Ethics Committee (IEC) (ICH E6, 1.27)
Institutional Review Board (IRB) (ICH E6, 1.31)
Opinion (in relation to Independent Ethics Committee) (ICH E6, 1.42)
Application
Principle 6 is applied through: (1) verifiable investigator adherence to
the protocol requirements; (2) submission of any protocol changes
to the sponsor and to the IEC/IRB (with approval/favourable opinion)
prior to their implementation; and (3) effective monitoring of the
study by the sponsor.
“The monitor should submit a written report to the sponsor after each
trial-site visit or trial-related communication.” (ICH E6, Section 5.18)
The sponsor has responsibility to monitor the study and ensure the
investigator and site staff comply with the protocol.
Implementation
The responsibility for implementing this principle is shared by IECs/
IRBs, investigators, sponsors, and regulators.
Definitions for:
Compliance (in relation to trials) (ICH E6, 1.15)
Monitoring (ICH E6, 1.38)
• that the subject’s participation in the trial is voluntary and that the
subject may refuse to participate or withdraw from the trial, at any
time, without penalty or loss of benefits to which the subject is
otherwise entitled;
• that the monitor(s), the auditor(s), the IEC/IRB, and the regula-
tory authority(-ies) will be granted direct access to the subject’s
original medical records for verification of clinical trial procedures
and/or data, without violating the confidentiality of the subject, to
the extent permitted by the applicable laws and regulations and
that, by signing a written informed consent form, the subject or
the subject’s legally authorized representative is authorizing such
access;
1) during the course of the study they are (or may be) exposed to an
investigational product about which the safety and efficacy is un-
known or incompletely understood; and
“Vulnerable persons are those who are relatively (or absolutely) in-
capable of protecting their own interests. More formally, they may
have insufficient power, intelligence, education, resources, strength,
“The third parties chosen should be those who are most likely to
understand the incompetent subject’s situation and to act in that
person’s best interest. The person authorized to act on behalf of
the subject should be given an opportunity to observe the research
as it proceeds in order to be able to withdraw the subject from the
research, if such action appears in the subject’s best interest.” (The
Belmont Report)
Implementation
The responsibility for implementing and overseeing the informed
consent process is shared by sponsors, clinical investigators, IECs/
IRBs, and regulatory authorities.
• the IEC/IRB reviews and approves the informed consent form and
other written information to be used in the study prior to its use;
and
See also:
Definitions for:
Informed Consent (ICH E6, 1.28)
Legally Acceptable Representative (ICH E6, 1.37)
Vulnerable Subjects (ICH E6, 1.61)
Well-being (of the trial subjects) (ICH E6, 1.62)
Application
Principle 8 is applied through development and implementation of
processes for evaluating risks and benefits of the research as ad-
ditional information becomes available during the course of the
study. Principle 8 encompasses (1) safety monitoring of the study
by investigator(s) and sponsor (including use of a data and safety
monitoring board [DSMB], where appropriate); (2) reporting serious
unexpected adverse events or other unanticipated risks to the spon-
sor, IEC/IRB, and regulators; (3) review by the IEC/IRB of any unan-
“At intervals defined by the protocol, the DSMB reviews and evalu-
ates the data on clinical efficacy and safety collected during the
study, and assesses reports on cumulated serious adverse events
(SAEs). The DSMB may also be requested by the sponsor to conduct
emergency reviews of data to assess safety-related issues. … At the
conclusion of the review, the DSMB provides a written recommenda-
tion to the sponsor regarding whether a protocol should be amended
and/or a study should proceed based on its review of the data and
the progress report submitted by the sponsor.” (Operational Guide-
lines for the Establishment and Functioning of Data and Safety Moni-
toring Boards, WHO TDR).
Implementation
Sponsors, IECs/IRBs, DSMBs (if applicable), and regulators share
responsibility for ongoing safety evaluations of the investigational
product(s).
See also:
The Council for International Organizations of Medical Sciences
(CIOMS) Management of Safety Information from Clinical Trials:
Report of CIOMS Working Group VI, Geneva, 2005
Definitions for:
Adverse Drug Reaction (ADR) (ICH E6, 1.1)
Adverse Event (AE) (ICH E6, 1.2)
Approval (in relation to Institutional Review Boards) (ICH E6, 1.5)
Independent Data Monitoring Committee (IDMC) (Data and Safety
Monitoring Board, Monitoring Committee, Data Monitoring
Committee) (ICH E6, 1.25)
Independent Ethics Committee (IEC) (ICH E6, 1.27)
Informed Consent (ICH E6, 1.28)
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Se-
rious ADR) (ICH E6, 1.50)
Unexpected Adverse Drug Reaction (ICH E6, 1.60)
Application
Principle 9 is applied through the responsibilities of the clinical inves-
tigator to the study subject and through the sponsor’s selection of
qualified investigator(s). (See also WHO GCP Principle 10: Staff Quali-
fications)
Implementation
The investigator is responsible for providing, or ensuring that sub-
jects have access to, medical care for medical problems arising dur-
ing their participation in the trial that are, or could be related to the
study intervention, and for following the subjects’ status until the
problem is resolved.
The IECs/IRBs is responsible for ensuring that the rights and welfare
of study subjects are protected. Consideration of investigator quali-
fications and experience and the adequacy of the site (including the
supporting staff, available facilities, and emergency procedures) by
the IEC/IRB will ensure that subjects have access to appropriate care
for medical problems arising during participation in the trial.
Definitions for:
Investigator (ICH E6, 1.34)
Subinvestigator (ICH E6, 1.56)
Well-being (of the trial subjects) (ICH E6, 1.62)
Application
Principle 10 is chiefly applied through the clinical investigator’s selec-
tion of appropriate staff to assist with the conduct of the study.
The investigator should ensure that staff are (1) familiar with the
study protocol and investigational product; (2) appropriately trained
to carry out trial-related duties; (3) informed/aware of their obliga-
tions to protect the rights, safety and welfare of the study subjects;
and (4) informed of any requirements imposed by the national regula-
tory authority for GCP and the conduct of clinical studies.
Implementation
The investigator bears primary responsibility for (1) selecting quali-
fied staff to assist in the conduct of the investigation; (2) ensuring
that study staff receive appropriate training, related to ethics and
consent procedures as well as requirements of the specific protocol;
(3) establishing clear procedures for activities related to the conduct
of the study; (4) assigning tasks to staff, based on their qualifications,
experience, and professional licenses; and (5) personally supervising
staff to ensure that they satisfactorily fulfill their study-related duties.
Although the investigator may delegate tasks to members of his/her
staff, nevertheless, the investigator retains overall responsibility for
the study and ensuring that his/her staff complies with applicable
laws and regulations for human subject protection and the conduct
of clinical research.
The IEC/IRB is responsible for ensuring that the rights and welfare
of study subjects are protected. Consideration of the site’s charac-
teristics (e.g. number and qualifications of supporting staff, available
See also:
Definitions for:
Investigator (ICH E6, 1.34)
Subinvestigator (ICH E6, 1.56)
Well-being (of the trial subjects) (ICH E6, 1.62)
Application
Principle 11 is applied through: (1) the understanding and applica-
tion of basic elements of data quality and integrity; (2) adherence to
the study protocol as well as applicable written procedures for col-
lecting, recording, reporting, maintaining and analysing clinical trial
information; and (3) the preparation of essential documents (includ-
ing source documents), at all stages throughout the conduct of the
clinical trial.
Examples include:
• accurate;
• legible;
• original;
Quality and integrity are both essential for data to be relied upon for
regulatory decision-making. Data quality and integrity are achieved
when each piece of data is collected in accordance with the study
protocol and procedures, giving attention to each of the quality
characteristics above, and subsequently handled (e.g. transcribed,
analysed, interpreted, reported) so that the quality characteristics
of the original data (i.e. accuracy, legibility, completeness, etc.) are
preserved.
Study monitoring also helps to ensure that data quality and integrity
are preserved throughout the study by, for example, verifying that
data transmitted to the sponsor in each CRF accurately reflect in-
formation about the study subject that was recorded in the medical
records or case histories.
Who must keep clinical trial information and for how long?
What is meant by the term “storage”?
All of the parties who conduct or oversee research involving human
subjects are expected to keep records and materials related to their
specific trial responsibilities and activities for the period of time re-
quired by national/local laws and regulations, or if such laws do not
exist, in accordance with GCP standards.
The sponsor
Note that consent forms should inform study subjects “[t]hat the
monitor(s), the auditor(s), the IRB/IEC, and the regulatory
authority(ies) will be granted direct access to the subject’s original
medical records for verification of clinical trial procedures and/or
data, without violating the confidentiality of the subject, to the extent
permitted by the applicable laws and regulations, and that by signing
a written informed consent form, the subject or the subject’s legally
acceptable representative is authorizing such access.” (ICH E6, 4.8)
(See also WHO GCP Principle 7: Informed Consent)
Implementation
IECs/IRBs, investigators, sponsors, and regulators all bear respon-
sibility for documenting their activities within GCP, and maintaining
records pertaining to duties related to the conduct or oversight of
the clinical trial for the time required under national or local law and
regulations. All parties are responsible for ensuring the accuracy,
completeness, legibility and availability (as necessary) of such docu-
ments.
Investigators prepare and maintain case histories that record all ob-
servations and other data pertinent to the investigation on each indi-
vidual administered the investigational drug or employed as a control
in the investigation.
See also:
Definitions for:
Case Report Form (ICH E6, 1.11)
Clinical Trial/Study Report (ICH E6, 1.13)
Compliance (in relation to trials) (ICH E6, 1.15)
Direct Access (ICH E6, 1.21)
Documentation (ICH E6, 1.22)
Essential Documents (ICH E6, 1.23)
Interim Clinical Trial/Study Report (ICH E6, 1.32)
Monitoring (ICH E6, 1.38)
Monitoring Report (ICH E6, 1.39)
Original Medical Record (ICH E6, 1.43)
Protocol (ICH E6, 1.44)
Source Data (ICH E6, 1.51)
Source Documents (ICH E6, 1.52)
Standard Operating Procedures (SOPs) (ICH E6, 1.55)
Application
Principle 12 is applied (1) through appropriate procedures to protect
the privacy of the subject, and (2) by document and data control to
protect the confidentiality of the subject’s information.
“It is the duty of the physician in medical research to protect the life,
health, privacy, and dignity of the human subject.” (Declaration of
Helsinki)
“(n) That the monitor(s), the auditor(s), the IRB/IEC, and the regu-
latory authority(ies) will be granted direct access to the subject’s
original medical records for verification of clinical trial procedures
and/or data, without violating the confidentiality of the subject, to
the extent permitted by the applicable laws and regulations and
that, by signing a written informed consent form, the subject or
the subject’s legally acceptable representative is authorizing such
access.”
Implementation
IECs/IRBs review/approve the informed consent procedures and
document to ensure, among other things, that there is adequate
explanation regarding (1) the risks related to release of the subject’s
private information, (2) how the confidentiality of the subject’s
records will be maintained, and (3) persons who may have access to
the subject’s records (e.g. monitor(s), auditor(s), the IEC/IRB, and the
regulatory authority(-ies)).
Sponsors ensure that sites (1) allow regulators, IECs/IRBs, and moni-
tors direct access to records necessary to verify compliance with
national/local laws and regulations pertaining to the conduct of clini-
cal trials, and (2) inform subjects about, and obtain their consent for,
such access.
Definitions for:
Audit (ICH E6, 1.6)
Confidentiality (ICH E6, 1.16)
Direct Access (ICH E6, 1.21)
Inspection (ICH E6, 1.29)
Original Medical Record (ICH E6, 1.43)
Subject Identification Code (ICH E6, 1.58)
Well-being (of the trial subjects) (ICH E6, 1.62)
Application
Principle 13 is applied through (1) appropriately characterizing the
investigational product (including any active comparator(s) and pla-
cebo, if applicable), (2) adhering to applicable Good Manufacturing
Practice (GMP) standards in the manufacturing, handling and storage
of the investigational product, and (3) using the product according to
the approved study protocol.
At the site, the investigator is responsible for ensuring that the in-
vestigational product(s) are “… stored as specified by the sponsor …
and in accordance with applicable regulatory requirements” … [and]
“are used only in accordance with the approved protocol.” (ICH E6,
Section 4.6)
Implementation
Responsibility for implementing this principle is shared by sponsors
(or contract manufacturers/ contract research organizations), inves-
tigators, and regulators.
The sponsor also develops the study protocol and investigator’s bro-
chure, monitors protocol compliance, and ensures that written pro-
cedures include instructions that the investigator/institution should
follow for the handling and storage of investigational products for the
trial and documentation thereof.
Definitions for:
Comparator (Product) (ICH E6, 1.14)
Compliance (in relation to trials) (ICH E6, 1.15)
Contract Research Organization (CRO) (ICH E6, 1.20)
Investigational Product (ICH E6, 1.33)
Monitoring (ICH E6, 1.38)
Application
Principle 14 is applied through development of procedures to control,
assure, and improve the quality of data and records and the quality
and effectiveness of processes and activities related to the conduct
and oversight of clinical research.
In the context of a clinical trial, quality may apply to data (e.g. data
are accurate and reliable) or processes (e.g. compliance with the
study protocol and GCP; ensuring informed consent; adequate data
handling and record-keeping, etc.). (See WHO GCP Principles 6: Pro-
tocol Compliance; 7: Informed Consent; 11: Records)
Implementation
All of the parties who conduct and oversee clinical trials (sponsors,
investigators, IECs/IRBs, and regulatory authorities) should adopt and
implement quality systems for the processes and activities for which
they are responsible.
IECs/IRBs develop and adopt SOPs for reviewing studies and inform-
ing the clinical investigator of any required modifications to the study
protocol, and for assuring that such modifications are in place before
See also:
Definitions for:
Audit (ICH E6, 1.6)
Audit certificate (ICH E6, 1.7)
Audit report (ICH E6, 1.8)
Audit trail (ICH E6, 1.9)
Compliance (in relation to trials) (ICH E6, 1.15)
Direct Access (ICH E6, 1.21)
Monitoring (ICH E6, 1.38)
Monitoring Report (ICH E6, 1.39)
Quality Assurance (QA) (ICH E6, 1.46)
Quality Control (QC) (ICH E6, 1.47)
Standard Operating Procedures (SOPs) (ICH E6, 1.55)
Documents on the CD
1. Guidelines for good clinical practice (GCP) for trials on pharmaceutical
products. Annex 3 of The Use of Essential Drugs Sixth report of the WHO
Expert Committee. Geneva. World Health Organization, 1995: 97–137.
http://www.who.int/medicines/en/
| 121
Other documents cited in the Handbook
1. WHO Expert Committee on Specifications for Pharmaceutical Preparations
– WHO Technical Report Series, No. 902 – Thirty-sixth Report (WHO; 2002;
219 pages): 5. Quality assurance – good manufacturing practices.
http://www.who.int/medicines/en/
5. The Belmont Report Ethical Principles and Guidelines for the Protection of
Human Subjects of Research. The National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research. April 18, 1979.
http://www.nihtraining.com/ohsrsite/guidelines/belmont.html
6. The ENGAGE Guideline for Good Clinical Practice Compliance and Quality
Systems Auditing. 21.08.1997. ENGAGE European Network of GCP Auditors
and other GCP Experts. (in process of revision).
7. ICH E2A: Clinical Safety Data Management: Definitions and Standards for
Expedited Reporting. 1994. http://www.ich.org/
8. ICH E2B(R): Revision of the E2B(M) ICH Guideline on Clinical Safety Data
Management. Data Elements for Transmission of Individual Case Safety
Reports. Step 3 undergoing consultation. May. 2005. http://www.ich.org/
10. ICH E9: Statistical Principles for Clinical Trials. 1998. http://www.ich.org/
11. ICH E10: Choice of Control Group and Related Issues in Clinical Trials. 2000.
http://www.ich.org/
12. ICH E11: Clinical Investigation of Medicinal Products in the Pediatric Popula-
tion. 2000. http://www.ich.org/
13. ICH M3: Maintenance of the ICH Guideline on Non-Clinical Safety Studies
for the Conduct of Human Clinical Trials for Pharmaceuticals. 1997.
http://www.ich.org/
16. United Nations International Covenant on Civil and Political Rights. 1966.
http://www.hrweb.org/legal/cpr.html
Related documents
1. ETH. Global list of national bioethics committees with contact details.
http://www.who.int/ethics/en
5. RHR. Guideline for obtaining informed consent for the procurement and
use of human tissues, cells and fluids in research.
http://www.who.int/reproductive-health/ hrp/SERG_guidelines.en.html
8. TDR Guidelines for Ethical Clearance & TDR Ethical Clearance Checklist
http://www.who.int/tdr/publications/
Canada
Good clinical practices.
http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/hp_gcp_e.html
European Union
European Agency for Evaluation of Medicines (EMEA). ICH topic E6. Note for
guidance on good clinical practice (CPMP/ICH/135/95)
http://www.emea.eu.int/pdfs/human/ich/013595en.pdf
India
Ethical guidelines for biomedical research on human subjects.
http://icmr.nic.in/ethical.pdf
Japan
Ministry of Health, Labour and Welfare. “Standards on the Implementation of
Clinical Trials on Drugs (New GCO)”.
Japan’s New GCP and Other Rules on Clinical Trials, Parts 1, 2, and 3 issued by
the Ministry of Health and Welfare with a copyright of 1998
South Africa
Guidelines for good practice in the conduct of clinical trials in human partici-
pants in South Africa.
http://196.36.153.56/docs/policy/trials/trials-full.html
Very special thanks to Dr N. Peter Maurice for drafting the first ver-
sion of the text and to Dr David Lepay and his team (Ms. Carolyn
Hommel and Mr. Stan W. Woollen) for revising the text and preparing
the final manuscript.
| 125
HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP)
HANDBOOK
FOR GOOD
CLINICAL
RESEARCH
PRACTICE
(GCP)
GUIDANCE FOR
IMPLEMENTATION
ISBN 92 4 159392 X
WHO