GOOD CLINICAL PRACTICE (GCP) WORKSHOP

CLINICAL RESEARCH MALAYSIA (CRM)

VENUE : DEWAN SEMINAR,
HOSPITAL SULTAN HAJI AHMAD SHAH, TEMERLOH
DATE : 12TH - 14TH APRIL 2014

Day 1 : 12TH APRIL 2014

TIME TOPIC
7.45 am - 8.20 am Registration & Breakfast
8.20 am - 8.30 am Welcome Address
Ice Breaking Session

8.30 am - 9.00 am Clinical Research in Malaysia and role of

Clinical Research Malaysia (CRM)

SESSION 1 : INTRODUCTION TO GCP & ETHICS OF CLINICAL RESEARCH

9.00 am - 9.30 am Overview of ICH/GCP and Malaysian GCP Guideline (GCP Chapter 2)

9.30 am 10.00 am ICH/GCP and Malaysian GCP Guideline compared

10.00 am 10.15 am Tea Break

10.15 am 11.00 am Overview of ethics of clinical research, ethical principles & requirements
(Helsinki Declaration)

11.00 am - 12.00 pm Independent Ethics Committee

(GCP Chapter 3)

12.00pm 1.00 pm Clinical Trial Protocol & Investigators brochure

(GCP Chapter 6 & 7)

1.00 pm - 2.00 pm Lunch Break

2.00 pm 4.00 pm Informed Consent
(GCP Section 4.8)

Group Exercise
Informed consent

4.00pm 5.00pm Feasibility study

5.00pm Tea and adjourn

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 Day 2 : 13TH APRIL 2014
TIME TOPIC
7.45 am - 8.20 am Registration & Breakfast
SESSION 2 : INVESTIGATORS RESPONSIBILITY

8.20 am 10.20 am Investigators 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
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

10.20 am 10.40 am Tea Break

10.40 am - 11.30 am Group Exercise
1. IP Accountability
2. CRF Completion
SESSION 3 : SPONSORS RESPONSIBILITY

11.30 am 1.00 pm Sponsors 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)

1.00 pm - 2.00 pm Lunch Break

2.00 pm 3.20 pm Group Exercise
Adverse event (AE) reporting & Safety Surveillance (Section 4.11 & 5.17)

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 (Contd) Day 2: 13TH APRIL 2014
TIME TOPIC
3.20 pm 3.40 pm Group Exercise
Role and Responsibilities of Investigator, IRB/IEC and Sponsor

3.40 pm 4.00 pm Tea Break

SESSION 4 : CONDUCTING RESEARCH IN MALAYSIA

4.00 pm 5.20 pm Oversight and Funding for clinical research in MOH

Role of NIH
MOH guidelines for clinical research
MREC
MOH Research Grant

5.20 pm Adjourn

Day 3 : 14TH APRIL 2014

TIME TOPIC

8.00 am - 8.30 am Registration & Breakfast

SESSION 4: CONDUCTING RESEARCH IN MALAYSIA

8.30 am 10.00 am Regulation of Clinical Research in Malaysia

10.00 am 10.30 am Tea Break

10.30 am 11.30 pm Revision

11.30 pm 12.30 pm GCP CERTIFICATION EXAM

12.30 pm Lunch & Adjourn