GCP guidelines

GCP guidelines for clinical research

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 in GCP  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 is GCP  A standard for designing, conducting , recording and reporting of studies involving human subjects.  Public assurance that the rights, safety and well-being of trial subjects are protected. Cl ini c al Trials or Studies D esigning C o n d uc t in g Monitoring R ec o rd ing An a l y sis Reporting

5. Research regulatory Basic Research Disease Re c o v er y Drug Recovery Preclinical D e v e l op m ent Clinical Trials Manufacturing Not regulated GLP GCP GM P

6. Declaration of Helsinki  World Medical Association - recommendations guiding medical doctors in biomedical research involving human participants Research with humans should be based on the results from animal and laboratory experimentation. Research protocols should be reviewed by an independent committee prior to initiation Informed consent from research participants is necessary Research should be conducted by medically/scientifically qualified individuals Risks should not exceed benefits  Revised - 1975, 1983, 1989, 1996, 2000, 2002, 2004, 2008

7. Evolution of GCP 1930s – US Food Drug & Cosmetic Act 1947 – Nuremberg Code 1962 - Kefauver Amendments (US) (following Thalidomide tragedy) 1964 – Declaration of Helsinki 1974 – National Research Act (US) 1979 - Belmont Report (US) 1986 – England – ABPI Guideline 1987 - France - Bonnes Pratiques Clinique 1989 – Scandinavia - Nordic Guidelines , Good Clinical Trial Practice 1990 – France – Huriet Law 1990 - EC - Good Clinical Practice for Trials on Medicinal Products in the European Community 1992 - WHO Guidelines, Australian Guidelines 1997 – ICH GCP became law in some countries 1999 - Malaysian GCP

8. The summary of the principles...!!! Conduct trials according to GCP Weigh risks vs. benefits Subjects wellbeing exceed the science Have adequate information to justify trial Write a sound protocol Receive IRB/IEC approval Use qualified physicians Use qualified & trained support staff Obtain informed consent Record information appropriately Confidentiality & data protection Handle investigational products appropriately Quality assurance

9. Principles of ICH GCP 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 is initiated, foreseeable risks and inconveniences should be 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 of the trial subjects are the most important considerations and should prevail over interests of science and society.

10. Principles of ICH GCP……. The available nonclinical and clinical information on 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/favourable opinion. Clinical trials should be scientifically sound, and described in a clear, detailed protocol

11. Principles of ICH GCP……. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion. 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 clinical trial participation.

12. Principles of ICH GCP……. 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 the quality of every aspect of the trial should be implemented.

13. The summary of the principles...!!! Conduct trials according to GCP Weigh risks vs. benefits Subjects wellbeing exceed the science Have adequate information to justify trial Write a sound protocol Receive IRB/IEC approval Use qualified physicians Use qualified & trained support staff Obtain informed consent Record information appropriately Confidentiality & data protection Handle investigational products appropriately Quality assurance

14. The Players Institutional Review Board/ Ethics committee The Investigator The Sponsor The Monitor