1. A S Nanivadekar Introduction to GCP

2. A S Nanivadekar Outline Definition and scope Definition and scope Purpose of clinical research Purpose of clinical research Evolution of GCP Evolution of GCP Players in GCP Players in GCP Checklists of players Checklists of players

3. A S Nanivadekar GCP = Good Clinical Research Practice GCP = Good Clinical Research Practice Purpose of GCP Purpose of GCP To protect the rights of research subjects (volunteers or patients) To protect the rights of research subjects (volunteers or patients) To ensure credibility of the data To ensure credibility of the data GCP is applicable to GCP is applicable to Prophylactic, diagnostic and therapeutic trials Prophylactic, diagnostic and therapeutic trials Drugs, devices and procedures Drugs, devices and procedures Epidemiological studies Epidemiological studies

4. A S Nanivadekar The purpose of clinical research is to create knowledge needed to improve health care. Without such knowledge, action for health care may be impossible, wasteful, expensive or harmful because it will have no logical or empirical basis. - IUTALD, 2001

5. A S Nanivadekar Evolution Nuremberg Code, 1947 Nuremberg Code, 1947 Declaration of Helsinki, 1964 → 2001 Declaration of Helsinki, 1964 → 2001 ICH GCP guidelines, 1996 ICH GCP guidelines, 1996 Ethical Guidelines for Biomedical Research in Human Subjects (ICMR), 2000 Ethical Guidelines for Biomedical Research in Human Subjects (ICMR), 2000 GCP Guidelines, CDSCO, New Delhi, 2001 GCP Guidelines, CDSCO, New Delhi, 2001

6. A S Nanivadekar Players in Clinical Research Investigators Investigators Sponsors Sponsors Regulatory agency Regulatory agency Ethics Committee Ethics Committee

7. A S Nanivadekar Investigator’s checklist - 1 Interest, expertise, time and facilities Interest, expertise, time and facilities Interaction with sponsor Interaction with sponsor Protocol, CRF, PIS and ICF Protocol, CRF, PIS and ICF Financial grant Financial grant Publication policy Publication policy Interaction with ethics committee Interaction with ethics committee Presentation and defense of protocol Presentation and defense of protocol Compliance with conditions of approval Compliance with conditions of approval

8. A S Nanivadekar Investigator’s checklist - 2 Implementation Implementation Organizing, briefing and supervising the team Organizing, briefing and supervising the team Facilitating informed consent process Facilitating informed consent process Completing and signing CRFs Completing and signing CRFs Reporting SAE Reporting SAE Interacting with monitor Interacting with monitor Reviewing and approving final report Reviewing and approving final report Archiving source documents Archiving source documents Preparing for audit and/or inspection Preparing for audit and/or inspection

9. A S Nanivadekar Sponsor’s checklist - 1 Scientific, regulatory and ethical basis of the protocol, PIS and ICF Scientific, regulatory and ethical basis of the protocol, PIS and ICF Investigator’s qualifications, training and experience Investigator’s qualifications, training and experience Regulatory and ethical approvals Regulatory and ethical approvals Publication policy Publication policy Quality of trial supplies Quality of trial supplies Initiation, monitoring and audit Initiation, monitoring and audit

10. A S Nanivadekar Sponsor’s checklist - 2 Data management and analysis Data management and analysis Drafting of study report Drafting of study report Preparation for inspection Preparation for inspection Archives of source documents Archives of source documents

11. A S Nanivadekar Regulator’s checklist Periodic review of current regulations from scientific and ethical angles Periodic review of current regulations from scientific and ethical angles Advance consultation to sponsors on protocols Advance consultation to sponsors on protocols Efficacy and safety criteria Efficacy and safety criteria Comparator product Comparator product Advisory panels for review of applications and decision making Advisory panels for review of applications and decision making Inspection of investigational centers Inspection of investigational centers

12. A S Nanivadekar Ethics Committee’s checklist - 1 Need for trial Need for trial Scientific aspects of protocol with ethical implications Scientific aspects of protocol with ethical implications Participants Participants Number Number Healthy volunteers or patients Healthy volunteers or patients Vulnerable persons Vulnerable persons

13. A S Nanivadekar Ethics Committee’s checklist - 2 Treatment Treatment Withdrawal of current treatment Withdrawal of current treatment Assignment of placebo Assignment of placebo Dosage and route Dosage and route Assessment of response Assessment of response Nature and frequency Nature and frequency Invasive or non-invasive Invasive or non-invasive Total blood drawn Total blood drawn

14. A S Nanivadekar Ethics Committee’s checklist - 3 Ethical aspects of protocol Ethical aspects of protocol Information and consent form Information and consent form Content and language Content and language Risks and benefits Risks and benefits Compensation or other payments Compensation or other payments Insurance for study-related injury Insurance for study-related injury Treatment after study Treatment after study Regulatory approval Regulatory approval

15. A S Nanivadekar Resourcefulness

16. A S Nanivadekar Thank you!