1. Good Clinical Practice (GCP)- An introduction Dr Noor Ibrahim Mohamed Sakian

2. Contents Background What is GCP? History – International Committee on Harmonisation (ICH) of GCP Principles of ICH GCP GCP rules of conduct o IRB/IEC o Investigators responsibilities o Sponsors responsibilities o Trial protocol o Investigator’s brochure o Essential documents

3. Background Academicians, clinicians involvement in clinical trials/research increasingly common In Malaysia all clinical investigators required to undergo (AND pass) Good Clinical Practice (GCP) course To ensure that investigator/s can conduct GCP compliant studies See slides.

4. IRB/IEC Institutional Review Board (IRB)/Independent Ethics Committee (IEC) o Responsibilities o Composition, Functions and Operations o Procedures o Records

5. Investigator Investigator's Qualifications and Agreements Adequate Resources Medical Care of Trial Subjects Communication with IRB/IEC Compliance with Protocol Investigational Product(s) Randomization Procedures and Unblinding Informed Consent of Trial Subjects Records and Reports Progress Reports Safety Reporting Premature Termination or Suspension of a Trial Final Report(s) by Investigator

6. Sponsor Manufacturing, Packaging, Labelling, and Coding Investigational Product(s) Supplying and Handling Investigational Product(s) Record Access Safety Information Adverse Drug Reaction Reporting Monitoring Audit Noncompliance Premature Termination of a Trial Clinical Trial/Study Reports Multicentre Trials Quality Assurance and Quality Control Contract Research Organization (CRO) Medical Expertise Trial Design Trial Management, Data Handling, and Record Keeping Investigator Selection Allocation of Responsibilities Compensation to Subjects and Investigators Financing Notification/Submission to Regulatory Authority/ies Confirmation of Review by IRB/IEC Information on Investigational Product(s)

7. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) Background Information Trial Objectives and Purpose Trial Design Selection and Withdrawal of Subjects Treatment of Subjects Assessment of Efficacy Assessment of Safety Statistics Direct Access to Source Data/Documents Quality Control and Quality Assurance Procedures Ethics Data Handling and Record Keeping Financing and Insurance Publication Policy

8. INVESTIGATOR’S BROCHURE Title Page Confidentiality Statement Contents of the Investigator’s Brochure o Table of Contents o Summary o Introduction o Physical, Chemical, and Pharmaceutical Properties and Formulation o Nonclinical Studies o Effects in Humans o Summary of Data and Guidance for the Investigator

9. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL Introduction Before the Clinical Phase of the Trial Commences During the Clinical Conduct of the Trial After Completion or Termination of the Trial

10. Conclusion Compliance to GCP guidelines is essential when generating clinical trial data for submission to regulatory authorities The principles established may also be applied to other clinical investigations that may have an impact on safety and well-being of human subjects Shukran!