Good Clinical Practice (GCP)- An introduction

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 • IRB/IEC • Investigators responsibilities • Sponsors responsibilities • Trial protocol • Investigator’s brochure • 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) • Responsibilities • Composition, Functions and Operations • Procedures • 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 • 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) • 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

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 • Table of Contents • Summary • Introduction • Physical, Chemical, and Pharmaceutical Properties and Formulation • Nonclinical Studies • Effects in Humans • Summary of Data and Guidance for the Investigator

9. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICALTRIAL • 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!