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GCP’S STANDARD PROGRAMME
GCP’s Revised Course Syllabus [Updated 2018]
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 (full day 8.00am – 5.00pm) |
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| Time | Topic | Speakers |
| 08.00am-08.30am | Registration | |
| 08.30am-08.40am | Welcome Address | Head of CRC |
| 08.40am-09.00am | Overview of Clinical Research in Malaysia | 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-01.30pm | Informed Consent (GCP Section 4.8) Group Exercise |
CRC, MREC or Investigator |
| 01.30pm-02.30pm | Lunch Break | |
| 02.30pm-04.00pm | Ethical Problems in Clinical Research & Research Misconduct Group Exercise |
CRC or Investigator |
| 04.00pm-04.20pm | Tea Break | |
| 04.20pm-05.00pm | Clinical Trial Protocol, Investigators Brochure & Essential Documents (GCP Chapter 6 & 7) | CRC or Investigator |
| 05.00pm | Adjourn | |
| Day 2 (full day 8.00am – 5.00pm) |
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| 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 • Study Design • 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) / Drug Accountability at Site (4.6) – Supply and Handling • Role of a Site Coordinator – Group Exercise (IP Accountability) • CTP and Amendments |
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) • AE Monitoring / Reporting |
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 (half day morning 8.00am – 12.00pm) |
||
| Time | Topic | Speakers |
| 08.00am-08.20am | Registration | |
| Session 3: Conducting research in Malaysia | ||
| 08.20am- 9.10am | Regulatory Aspects of Clinical Research Trials in Malaysia | NPRA |
| 9.10am-10.00am | GCP Inspection | NPRA |
| 10.00am-10.20am | Tea Break | |
| 10.20am-11.00am | Evaluation / Revision Before GCP Exam | – |
| 11.00am-12.00pm | GCP Certification Exam | NPRA |
| 01.00pm-02.00 pm | Lunch Break and 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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'A theory is something nobody believes, except the person who made it. An experiment is something everybody believes, except the person who made it.'
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Albert Einstein
Nobel Prize Laureate (Physics)