Page 90 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

APPENDIX 9: Essential Documents Required for First-In-Human (FIH) / First Dose in Human
Trials Submission

No Document Explanatory notes
Investigator’s documents
1. IA-HOD-IA form Required for all FIH research submitted to MREC.
Investigator’s agreement, head of department’s and
institutional approval, to be completed for all Principal
Investigators (including Coordinating PI and PI at site)
2. Curriculum Vitae Required for all FIH research submitted to MREC.
A summary of the investigator’s education, professional
history, and job qualifications or other documentation
evidencing the investigator’s qualifications
3. GCP certificate Required for all FIH Interventional Study
The certificate indicating successful participation in a
Malaysian GCP workshop. The certificate is issued upon
passing the workshop exit exam.

4. Declaration of Conflict Required for all FIH research submitted to MREC.
of Interest by Principal Document to be completed by the Corresponding Principal
Investigator Investigator on behalf of the study team to declare any conflict
of interest.
5. Advanced Cardiovascular Life Support Required for all FIH research submitted to MREC.
(ACLS) Certificate The certificate indicates investigators are trained in this
advanced course which highlights the importance of high-
performance team dynamics and communication, systems of
care, recognition and intervention of cardiopulmonary arrest,
immediate post-cardiac arrest, acute dysrhythmia, stroke, and
acute coronary syndromes (ACS).
Research documents
6. Covering letter Required for all FIH research submitted to MREC.
A letter accompanying a submission to explain the purpose of
the submission and list of documents submitted.
7. Study Protocol Required for all FIH research submitted to MREC.
A document that describes the objective(s), design,
methodology, statistical considerations, and organization of a
research. The protocol usually also gives the background and
the rationale for the study, but these could be provided in
other protocol referenced documents.
8. Investigator’s brochure Required for all FIH research submitted to MREC.
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) in human subjects (ICH GCP 1.36)
9. Investigational Medicinal Product Required for all FIH studies submitted to MREC
Dossier (IMPD) or Chemistry, Document containing Investigational Medicinal Product
Manufacturing and Control (CMC) data Dossier (IMPD) or Chemistry, Manufacturing and Control
(CMC) data.
10. Non-Investigational Medicinal Product Required if applicable
(NIMP) dossiers Dossier on the NIMP agents used in the study (eg: challenge
agents)

74 NIH Guidelines for Conducting Research in MOH, 2021