Page 71 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

EXPLANATORY NOTES ON ADMINISTRATIVE REQUIREMENTS OF DOCUMENTS
SUBMITTED FOR POST APPROVAL APPLICATIONS

No. Document Explanatory notes
Investigator’s documents
1. Curriculum Vitae Required whenever any changes to study team/investigators
are submitted for consideration.
A summary of the investigator’s education, professional
history, and job qualifications or other documentation
evidencing the investigator’s qualifications.
2. GCP certificate Required whenever any changes to the study team/
investigators of an interventional study are submitted.
The certificate indicates successful participation in a
Malaysian GCP workshop. The certificate is issued upon
passing the workshop exit exam.
3. Declaration of Conflict of Interest by Required whenever any changes to study team/investigators
Principal Investigator are submitted for consideration..
Document to be completed by the Corresponding Principal
Investigator on behalf of the study team to declare any
conflict of interest.

Research documents
4. Cover letter Required for amendments, protocol deviations, serious adverse
events, closure, interim reports, AOR submissions to MREC.
A letter accompanying a submission to explain the purpose of
the submission and list of documents submitted.

5. Study Protocol/Proposal Required whenever any changes to the document are
submitted to MREC for consideration.
A document that describes the background and rationale
for the study, objective(s), design, methodology, statistical
considerations, and organization of a research.
For studies fulfilling criteria for application of waiver of
informed consent, kindly state this clearly in the protocol and
provide justification.
6. Investigator’s brochure Required whenever any changes to the document are
submitted to MREC for consideration.
A compilation of the clinical and non-clinical data on the
investigational product(s) which is relevant to the study of the
investigational product(s)/device(s) in human subjects (ICH
GCP 1.36)
7. Information Sheet & Informed Consent Required whenever any changes to the document are submitted
Form to MREC for consideration.
Document containing research information intended for subjects
and to document subject’s consent to participate in the research.
Compulsory to have in English and Bahasa Malaysia languages,
unless otherwise specified in study proposal/protocol.
Optional for other languages (Simplified Chinese/Tamil and etc)

NIH Guidelines for Conducting Research in MOH, 2021 55