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

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
MREC, the MOH 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
CTIL & CTX
GMP for investigational product

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QUOTE OF THE WEEK

'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)