The details to be covered by each topic specified in the curriculum are described below:

1. Overview of ICH/GCP and Malaysian GCP Guideline

New drug development & Phases of clinical trials
GCP in that context, its history & development
Principles of GCP (13 basic principles)
Malaysian GCP: history & development
How Malaysian GCP differs from ICH GCP?

2. Overview of ethics of clinical research

Why concern with ethics? Historical origin of ethical concerns & Helsinki Declaration
Three fundamental ethical principles( Respect for person, beneficence & non-maleficence, justice)
Seven requirements that make clinical research ethical
Malaysian GCP: history & development
Two key procedures for protecting human research subjects (IEC/IRB review and approval, Informed consent by subject)

3. Independent Ethics Committee

Definition & requirements for IEC review
Functions of IEC/IRB in human subject protection
Composition, function & operations of IRB/IEC
Waiver from IEC review

4. Informed Consent

Definition & requirements for Informed consent
Valid informed consent, process & procedures
Elements of patient information
Concept of assent
Some special situations (Legally incompetent, Illiterate or subjects who are unable to read, Non-therapeutic trial, Emergency situation, Vulnerable subjects)
Waiver of informed consent

5. Ethical problems in clinical research & Research misconduct

The dual hat problem: Physician as investigator
Randomization & Blinding
Use of placebo
Preliminary data & emerging trends in the course of clinical research
Definition of misconduct
Conflict of interest
Publication ethics
Clinical trial registration

6. Clinical Trial Protocol & Investigators brochure

Definition of Protocol and requirements for protocol
Checklist for GCP compliant protocol
Definition of Investigators brochure
Typical contents of Investigators brochure

7. Investigators responsibility

Qualifications & CTA (4.1)
Adequate resources (4.2)
Medical care of trial subjects (4.3)
Communications with IRB/IEC (4.4)
Study Initiation
Patient Recruitment
Compliance with protocol (4.5)
Randomization & Unblinding (4.7)
Case Report Form Completion and Source Documents
Records, Reports & Essential Documents (4.9, 4.10, 4.13 & Chapter 8 )
Investigational Product (IP) Accountability at site (4.6)
Role of a Site Coordinator

8. Excellent investigative site: What it takes?

Excellence, what does it mean?
Role of institution (hospital)
Role of the research team
Good recruitment practices & patient recruitment strategy
Role of sponsor

9. Sponsors responsibility

QA and QC (5.1)
Trial Management, data handling , record keeping (5.5) & access (5.15)
Selection of Investigator / Site (5.6)
Allocation of responsibilities (5.7)
Compensation to subjects, investigators & Financing (5.8. 5.9)
Notification to regulatory & submission to IRB/IEC (5.10, 5.11)
Study monitoring (5.18)
Audit & Inspection (5.19, 5.20)
Premature termination (4.12, 5.21)
Multicentre trial (5.23)
Archiving (5.5)

10. Adverse event reporting & Safety surveillance

Adverse Event Monitoring & Reporting
Safety surveillance in Clinical Trial
Exercise: Safety reporting vignette

11. ICH/GCP and Malaysian GCP Guideline compared

Summary of similarities & differences between ICH/GCP and Malaysian GCP Guideline

12. Clinical Research in Malaysia and role of CRC

New drug development & contract clinical research
Growth of CRO industry & clinical trial activities in Malaysia
Malaysians competitive strengths
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

DG circular on NIH guideline for conducting research in MOH
Requirements for institutional & ethics approvals, research registration, contractual issues (CTA) and study budgets, insurance

14. Regulation of clinical research in Malaysia

Laws regulating drugs & drug trials
GMP for investigational product


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'A theory is something nobody believes, except the person who made it. An experiment is something everybody believes, except the person who made it.'

Albert Einstein
Nobel Prize Laureate (Physics)