GCP guidelines
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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.
GCP guidelines
- 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