GOOD CLINICAL PRACTICE WORKSHOP 1/2018
Assalāmu 'Alaikum Warahmatullāhi Wabarakātuh
Dear All IIUM Community,
We are pleased to invite you to participate in the Good Clinical Practice (GCP) Workshop 1/2018 as detailed below:
Date: 10th – 12th March 2018 (Saturday - Monday)
Time: 8.00 a.m. - 5.00 p.m.
Venue: Multipurpose Hall, Kulliyyah of Medicine, IIUM
Early Bird Fee (Before 28th February 2018):
RM500.00 : IIUM Postgraduate Student
RM800.00 : IIUM Staff
Non-IIUM : RM1000.00
RM700.00 : IIUM Postgraduate Student
RM1,000.00 : IIUM Staff
RM1,200.00 : Non IIUM Staff
RM100.00 : IIUM Postgraduate Student/IIUM Staff/ Non IIUM
The workshop aims that any clinical research you embark on is conducted in accordance with international ethical and scientific standards.
Certificate of Achievement will be issued by the National Committee for Clinical Research, Ministry of Health Malaysia to participants who attend all sessions and pass the GCP examination after the workshop ends. The GCP examination will be conducted by the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia.
Please RSVP by 5th March 2018 (Monday) as seats are limited to 50 participants only and 10 participants for repeat examination. Registration will be strictly on first come first serve basis.
Kindly fill in the online registration form via https://goo.gl/forms/QJW0T8UAO3si8N7J2
You may contact us if you require additional information or further clarification regarding this matter i.e. Br. A’imullah at 09-570 4733 (email@example.com) or Sr. Atika at 09-570 4406 (firstname.lastname@example.org).
We look forward to meet you in the workshop.
Thank you and Wassalāmu cAlaikum Warahmatullāhi Wabarakātuh
ASSOC. PROF. DATO’ DR. MOHD BASRI BIN MAT NOR
Head, Research and Innovation cum
Chairman, GCP Workshop 1/2018
Kulliyyah of Medicine, IIUM
Good Clinical Practice (GCP)
GCP is a set of rules and regulation that is provided by ICH, an international body that regulates clinical trials involving human subjects. It is a standard for the design, conduct, performance, monitoring, auditing, recording, analysing and reporting of clinical trials that provides assurance that the; Data and reported results are credible and accurate, and
Rights, integrity and confidentiality of trials subjects are protected.
In clinical trials, the protection of the subject is paramount especially when untested therapy is used. There must also be assurance about the conduct of clinical trials in terms of elimination of cheating, fraud or accidental error. Problems of poor study design must be avoided. Adherence to GCP is vital otherwise, subjects participating in the trials may be put at risk or the clinical trial data submitted may be rejected by health authorities and the scientific committee, if found to be unreliable. Also, the research credibility of the researcher and the research institution may be damaged.
Malaysia adopted GCP in 1999, and since then doctors are required to undergo training on GCP leading to certification prior to participation in clinical trials. This course is specifically designed to meet this requirement.
1. To understand the principles underlying GCP and its specific rules of conduct.
2. To provide experience in the key skills required through simulation in classroom settings.
3. To provide some of the resources required to design and to conduct GCP trial.
4. To achieve an overall understanding on how to conduct GCP compliant clinical trial.
Who Should Participate?
Clinicians, nurses and allied health professionals involved with research, research associates and study coordinators, Biomedical and research scientists, statisticians and database managers, experienced research personnel who are interested in updating their knowledge regarding GCP.
Syllabus for NCCR Approved GCP Course 2017
1. Principles of GCP and Malaysian GCP Guidelines
2. Clinical Research in Malaysia
3. Informed Consent/Patient Information Sheed (Process & Documentation)
4. IRB/IEC: Composition, Functions and Operations (IREC & MREC)
5. Role of Investigator
6. Study Design, Clinical Trials Protocol and Amendments
7. Supply and Handling of Investigational Products/Drug Accountability and Archiving
8. Clinical Trial: Investigator Brochure and Essential Document
9. Sponsor/Study Monitor Roles
10. Adverse Event Reporting, Documentation and Safety Surveillance
11. Good Clinical Data Management Practice and Good Statistical Practice
12. Clinical Trial Publication
13. GCP Inspection
14. Regulatory Aspects of Clinical Trial in Malaysia