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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