CONTENT OF GCP
The details to be covered by each topic specified in the curriculum are described below:
1. Overview of ICH/GCP and Malaysian GCP Guideline
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New drug development & Phases of clinical trials |
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GCP in that context, its history & development |
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Principles of GCP (13 basic principles) |
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Malaysian GCP: history & development |
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How Malaysian GCP differs from ICH GCP? |
2. Overview of ethics of clinical research
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Why concern with ethics? Historical origin of ethical concerns & Helsinki Declaration |
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Three fundamental ethical principles( Respect for person, beneficence & non-maleficence, justice) |
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Seven requirements that make clinical research ethical |
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Malaysian GCP: history & development |
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Two key procedures for protecting human research subjects (IEC/IRB review and approval, Informed consent by subject) |
3. Independent Ethics Committee
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Definition & requirements for IEC review |
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Functions of IEC/IRB in human subject protection |
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Composition, function & operations of IRB/IEC |
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MREC, the MOH IEC |
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Waiver from IEC review |
4. Informed Consent
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Definition & requirements for Informed consent |
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Valid informed consent, process & procedures |
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Elements of patient information |
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Concept of assent |
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Some special situations (Legally incompetent, Illiterate or subjects who are unable to read, Non-therapeutic trial, Emergency situation, Vulnerable subjects) |
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Waiver of informed consent |
5. Ethical problems in clinical research & Research misconduct
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The dual hat problem: Physician as investigator |
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Randomization & Blinding |
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Use of placebo |
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Preliminary data & emerging trends in the course of clinical research |
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Definition of misconduct |
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Conflict of interest |
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Publication ethics |
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Clinical trial registration |
6. Clinical Trial Protocol & Investigators brochure
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Definition of Protocol and requirements for protocol |
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Checklist for GCP compliant protocol |
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Definition of Investigators brochure |
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Typical contents of Investigators brochure |
7. Investigators responsibility
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Qualifications & CTA (4.1) |
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Adequate resources (4.2) |
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Medical care of trial subjects (4.3) |
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Communications with IRB/IEC (4.4) |
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Study Initiation |
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Patient Recruitment |
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Compliance with protocol (4.5) |
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Randomization & Unblinding (4.7) |
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Case Report Form Completion and Source Documents |
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Records, Reports & Essential Documents (4.9, 4.10, 4.13 & Chapter 8 ) |
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Investigational Product (IP) Accountability at site (4.6) |
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Role of a Site Coordinator |
8. Excellent investigative site: What it takes?
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Excellence, what does it mean? |
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Role of institution (hospital) |
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Role of the research team |
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Good recruitment practices & patient recruitment strategy |
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Role of sponsor |
9. Sponsors responsibility
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QA and QC (5.1) |
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Trial Management, data handling , record keeping (5.5) & access (5.15) |
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Selection of Investigator / Site (5.6) |
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Allocation of responsibilities (5.7) |
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Compensation to subjects, investigators & Financing (5.8. 5.9) |
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Notification to regulatory & submission to IRB/IEC (5.10, 5.11) |
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Study monitoring (5.18) |
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Audit & Inspection (5.19, 5.20) |
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Premature termination (4.12, 5.21) |
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Multicentre trial (5.23) |
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Archiving (5.5) |
10. Adverse event reporting & Safety surveillance
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Adverse Event Monitoring & Reporting |
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Safety surveillance in Clinical Trial |
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Exercise: Safety reporting vignette |
11. ICH/GCP and Malaysian GCP Guideline compared
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Summary of similarities & differences between ICH/GCP and Malaysian GCP Guideline |
12. Clinical Research in Malaysia and role of CRC
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New drug development & contract clinical research |
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Growth of CRO industry & clinical trial activities in Malaysia |
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Malaysians competitive strengths |
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CRC and its role in promoting clinical research (both contract & academic) |
13. Oversight and Funding for clinical research in MOH: Role of NIH, MOH guidelines for clinical research, MREC and MOH Research Grant
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DG circular on NIH guideline for conducting research in MOH |
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Requirements for institutional & ethics approvals, research registration, contractual issues (CTA) and study budgets, insurance |
14. Regulation of clinical research in Malaysia
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Laws regulating drugs & drug trials |
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CTIL & CTX |
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GMP for investigational product |