GCP’S STANDARD PROGRAMME

While organizer may vary the order of the program (move presentation earlier or later) as the need arises but should however strive to maintain the logical order of certain sequence of the presentations (for example, Overview should come before detailed presentation of materials covered by the Overview).

Day 1
Time Topic Speakers
08.00am -08.30am Registration
08.30am -08.40am Welcome Address Head of CRC
08.40am -09.00am Clinical Research in Malaysia and Role of CRC Head of CRC
Session 1 : Introduction to GCP & Ethics of Clinical research
09.00am -09.30am Overview of ICH/GCP and Malaysian GCP Guideline(GCP Chapter 2) CRC, MREC or Investigator
09.30pm -10.00pm ICH/GCP and Malaysian GCP Guideline Compared CRC or Investigator
10.00am –10.20am Tea Break
10.20am -11.00am Overview of Ethics of Clinical Research, Ethical Principles & Requirements (Helsinki Declaration) CRC, MREC or Investigator
11.00am -11.30am Independent Ethics Committee (GCP Chapter 3) MREC
11.30am -01.00pm Informed Consent (GCP Section 4.8) CRC, MREC or Investigator
01.00pm –02.00pm Lunch Break
02.00pm -02.30pm Informed Consent (cont’d)
Group Exercise
CRC, MREC or Investigator
02.30pm -04.00pm Ethical Problems in Clinical Research
Group Exercise
CRC or Investigator
04.00pm –04.20pm Tea Break/Adjourn
04.20pm -05.00pm Clinical Trial Protocol & Investigators Brochure (GCP Chapter 6 & 7) CRC or Investigator
05.00pm Adjourn
Day 2
Time Topic Speakers
08.00am -08.30am Registration
Session 2 : Investigator’s responsibility
08.20am -10.00am Investigator’s responsibility (GCP Chapter 4)
• 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- Group Exercise – CRF Completion
CRC, MREC or Investigator
10.00am –10.20am Tea Break
10.20am -11.30am Investigator’s responsibility (GCP Chapter 4)(cont’d)
• 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 Group Exercise – IP Accountability
CRC, MREC or Investigator
Session 2 : Sponsor’s responsibility
11.30am -01.00pm Sponsor’s Responsibility (Section 5 &8 )
• 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)
• Information on IP, manufacturing, packaging & labelling IP, and Supplying and handling IP (5.12, 5.13, 5.14)
• Study monitoring (5.18)
• Audit & Inspection (5.19, 5.20)
• Premature termination (4.12, 5.21)
• Multicentre trial (5.23)
• Archiving (5.5)
CRC or Industry Sponsor
01.00pm –02.00pm Lunch Break
02.00pm -03.00pm Adverse event reporting & Safety surveillance (Section 4.11 & 5.17) CRC or Industry Sponsor
03.00pm -03.40pm Group Exercise : Role and Responsibilities of Investigator, IRB/IEC and Sponsor CRC or Industry Sponsor
03.40pm –04.00pm Tea Break
04.00pm -05.00pm Optional topic (see below)
05.00pm Adjourn
Day 3
Time Topic Speakers
08.00am -08.20am Registration
Session 3: Conducting research in Malaysia
08.20am -08.50am Optional topic (see below) CRC
08.50am -10.00am Oversight and Funding for clinical research in MOH: Role of NIH, MOH guidelines for clinical research, MREC and MOH Research Grant NIH
10.00am –10.20am Tea Break
10.20am -11.00am Optional topic (see below)(e.g : Clinical Trial Publication)
11.00am -11.50am Regulation of clinical Research in Malaysia NPCB
11.50am -12.00pm Evaluation / Break before exam
12.00pm -01.00pm GCP Certification Exam NPCB
01.00pm –02.00 pm Lunch Break/Adjourn
Topics below are optional if time permit :
Research Misconduct CRC/Investigator/MREC
Legal aspects of clinical research Invited lawyer
Good Clinical Laboratory Practice (GCLP) Invited Lab
Good Statistical Practice (GSP) Invited statistician
Good Clinical Data Management Practice (GCDMP) Invited Data Manager
Feasibility Study & Clinical Trial Agreement Invited Delivery Management Officer
Clinical Trial Publication Invited Medical Writer
Excellent investigative site: What it takes? (or Review – Study Time) Selected experienced sites

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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)