Professional Documents
Culture Documents
PAYMENT
Payment must be submitted before 1ST APRIL 2019 and kindly notify the CRC HSNZ committee by email
Method of payment (please √):
Cash
Bank Transfer
SIGNATURE : _________________________________________
OVERVIEW
Good Clinical Practice (GCP) is a set of rules and
regulations that is provided by International
Conference on Harmonisation (ICH), an
international body that regulates clinical trials
MALAYSIAN GUIDELINE FOR GOOD CLINICAL
involving human subjects. It is a standard for the
PRACTICE
design, conduct, performance monitoring,
You may download the copy of the GCP
auditing, recording, analyses and reporting of WORKSHOP CONTENTS handbook (3rd edition) from
clinical trials that provide assurance that the Overview of ICH/GCP and Malaysian GCP www.crc.gov.my/guidelines/ and read
data and reported results are credible and Overview of ethics of clinical research beforehand.
accurate; and the rights, integrity and Ethics and regulations of clinical trials
confidentiality of trial subjects are protected. Role of IRB/IEC
Informed consent
OBJECTIVES OF THE WORKSHOP Clinical Trial Protocol & Investigator’s
1. To understand the principles underlying GCP Brochure
and its specific rules of conduct.
Safety monitoring and reporting
2. To provide experience in the key skills
Investigator’s responsibility (Study initiation,
required through simulation in a classroom WHO SHOULD PARTICIPATE
patient recruitment, CRF completion and
setting.
source documents, drug accountability, role Clinical physicians in Ministry of Health
3. To provide some of the resources required to
of site coordinator, essential documents, Any clinicians that involved with clinical trial
design and conduct GCP trial. Clinical Research Associate
archiving at site)
4. To achieve an overall understanding on how Clinical trial pharmacist
Working with Sponsor (selection of
to conduct GCP compliant clinical studies. Postgraduate students
investigator/site, agreement including
finance, compensation for trial related Clinical trial statistician
injury, archiving central lab, audit and
inspection
Oversight and funding for clinical research in
MOH
Malaysia adopted GCP in 1999. Since then Regulation of clinical research in Malaysia
doctors are required to undergo training on GCP
leading to certification prior to participation in
clinical trials. This workshop is specifically
designed to meet this requirement.