Good Clinical Practice (GCP) is an international quality standard that provides protection for human subjects in clinical trials. It outlines ethical and scientific standards for trial design, conduct, and reporting. The key principles of GCP are that clinical trials must be justified based on prior evidence; subject well-being must be prioritized over scientific objectives; and trials require oversight from ethics committees and qualified investigators. GCP aims to ensure clinical trial data are credible and that subjects' rights and safety are protected.

1. Good Clinical Practice
Dr.Sunanda Nandikol PharmD
Assistant professor,
Clinical Pharmacy Practice Department
BLDEA’s SSM College of Pharmacy &
Research Centre,Vijayapura

2. Objectives
Define GCP
Outline the principles of GCP
The players involved inGCP
Should follow GCP

3. INTRODUCTION
• Good Clinical Practice (GCP) is an international ethical and scientific quality
standard for designing, conducting, recording and reporting trials that involve the
participation of human subjects. Compliance with this standard provides public
assurance that the rights, safety and well-being of trial subjects are protected,
consistent with the principles that have their origin in the Declaration of Helsinki,
and that the clinical trial data are credible.
• The objective of this ICH GCP Guideline is to provide a unified standard for the
European Union (EU), Japan and the United States to facilitate the mutual
acceptance of clinical data by the regulatory authorities in these jurisdictions.

4. What isGCP
• A standard for designing,
conducting, recording and
reporting of studiesinvolving
human subjects.
• Public assurance that the
rights,safety and well-
being of trialsubjects are
protected.
Clinical
Trials or
Studies
Designing
Conductin
g
Monitoring
Recording
Analysis
Reporting

5. Research regulatory
Basic
Research
Disease
Recovery
Drug
Recovery
Preclinical
Development
Clinical Trials Manufacturi
ng
Not regulated
GLP
GCP
GMP

6. Declaration of Helsinki
World MedicalAssociation -recommendations guiding medical
doctors in biomedical research involving human participants
1. Research with humans should be based on the results from animal and
laboratory experimentation.
2. Research protocols should be reviewed by an independent committee
prior to initiation
3. Informedconsent from research participants isnecessary
4. Research should be conducted by medically/scientifically qualified
individuals
5. Risksshouldnotexceed benefits
Revised -1975, 1983, 1989, 1996, 2000, 2002, 2004,2008

7. Evolution of GCP
1930s–USFood Drug&Cosmetic Act
1947–Nuremberg Code
1962- Kefauver Amendments(US)(following Thalidomide tragedy)
1964–Declaration of Helsinki
1974–National Research Act (US)
1979- BelmontReport (US)
1986–England –ABPI Guideline
1987- France - Bonnes Pratiques Clinique
1989–Scandinavia - Nordic Guidelines , Good Clinical TrialPractice
1990–France –Huriet Law
1990- EC - Good Clinical Practice forTrialson Medicinal ProductsintheEuropean Community
1992- WHOGuidelines, AustralianGuidelines
1997–ICHGCP became lawinsome countries
1999- Malaysian GCP

8. The summary of theprinciples...!!!
1. Conduct trials according toGCP
2. Weigh risksvs. benefits
3. Subjects wellbeing exceed thescience
4. Have adequate information to justify trial
5. Write a soundprotocol
6. Receive IRB/IECapproval
7. Use qualified physicians
8. Use qualified & trained support staff
9. Obtain informed consent
10. Record information appropriately
11. Confidentiality & data protection
12. Handle investigational products appropriately
13. Quality assurance

9. Principles of ICHGCP
 Clinical trials should be conducted in accordance with the
ethical principles that have their origin in the Declaration of
Helsinki, and that are consistent with GCP and the applicable
regulatory requirement(s).
 Before a trial isinitiated, foreseeable risksand inconveniences
shouldbe weighed against the anticipated benefit for the
individual trial subject and society. A trial should be initiated and
continued only if the anticipated benefits justify the risks.
 The rights,safety, and well-being ofthetrialsubjectsare themost
importantconsiderations and should prevail over interests of
science and society.

10. Principles of ICHGCP…….
 The available nonclinical and clinical informationon an
investigational product should be adequate to support the
proposed clinical trial.
 Clinical trials should be scientifically sound, and described in a clear,
detailed protocol.
 A trial should be conducted in compliance with the protocol that
has received prior institutional review board (IRB)/independent
ethics committee (IEC) approval/favourableopinion.
 Clinical trials should be scientifically sound, and described in a
clear, detailed protocol

11. Principles of ICHGCP…….
 A trial should be conducted in compliance with the protocol that
has received prior institutional review board (IRB)/independent
ethics committee (IEC) approval/favourableopinion.
 The medical care given to, and medical decisions made on behalf
of, subjects should always be the responsibility of a qualified
physician or, when appropriate, of a qualified dentist.
 Each individual involved in conducting a trial should be qualified
by education, training, and experience to perform his or her
respective task(s).
 Freely given informed consent should be obtained from every
subject prior to clinicaltrial participation.

12. Principles of ICHGCP…….
 All clinical trial information should be recorded, handled, and
stored in a way that allows its accurate reporting, interpretation
and verification
 The confidentiality of records that could identify subjects should
be protected, respecting the privacy and confidentiality rules in
accordance with the applicable regulatory requirement(s).
 Investigational products should be manufactured, handled, and
stored in accordance with applicable good manufacturing
practice (GMP). They should be used in accordance with the
approved protocol.
 Systems with procedures that assure thequality ofevery aspect
of the trial should be implemented.

13. The summary of theprinciples...!!!
1. Conduct trials according toGCP
2. Weigh risksvs. benefits
3. Subjects wellbeing exceed thescience
4. Have adequate information to justify trial
5. Write a soundprotocol
6. Receive IRB/IECapproval
7. Use qualified physicians
8. Use qualified & trained support staff
9. Obtain informed consent
10. Record information appropriately
11. Confidentiality & data protection
12. Handle investigational products appropriately
13. Quality assurance

14. The Players
 Institutional Review Board/ Ethicscommittee
 The Investigator
 The Sponsor
 The Monitor