Page 65 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

Initial Submission prior to the study commencement
During this planning stage the following documents should be generated and
should be on file of investigators

Document Purpose
1. INVESTIGATOR’S BROCHURE To document that investigator is informed in a timely manner
UPDATES (where applicable) of relevant information as it becomes available
2. ANY REVISION TO: To document revisions of these trial related documents that
- protocol/amendment(s) and CRF take effect during trial/research
- informed consent form
- any other written information
provided to subjects
- advertisement for subject
recruitment (if used)
3. DATED, DOCUMENTED To document that the amendment(s) and/or revision(s) have
APPROVAL/FAVOURABLE been subject to IRB/IEC review and were given approv-al/
OPINION OF INSTITUTIONAL favourable opinion. To identify the version number and date of
REVIEW BOARD (IRB) / the document(s)
INDEPENDENT ETHICS
COMMITTEE (IEC) OF THE
FOLLOWING (where applicable) :
- protocol amendment(s)
- revision(s) of:
- informed consent form
- any other written information to be
provided to the subject
- advertisement for subject
recruitment (if used)
- any other documents given
approval/favorable opinion
4. REGULATORY To update whenever changes to investigators have been
AUTHORITY(IES) approved via amendment.
AUTHORIZATIONS/
APPROVALS/
NOTIFICATIONS
WHERE REQUIRED FOR:
- protocol amendment(s) and other
documents
5. CURRICULUM VITAE FOR To document instructions needed to ensure proper storage,
NEW INVESTIGATOR(S) packaging, dispensing and disposition of investigational
AND/OR SUBINVESTIGA-TOR(S) products and trial-related materials
6. UPDATES TO NORMAL To document normal values and ranges that are revised
VALUE(S)/RANGE(S) FOR during the trial
MEDICAL/LABORATORY/ TECHNICAL
PROCEDURE(S)/TEST(S) INCLUDED
IN THE PROTOCOL

7 UPDATES OF MEDICAL/ To document that tests remain adequate throughout the trial
LABORATORY/TECHNICAL period
PROCEDURES/TESTS
(where required)
8. DOCUMENTATION OF To document shipment dates, batch numbers and method
INVESTIGATIONAL PRODUCT(S) of shipment of investigational product(s) and trial- related
AND TRIAL RELATED MATERIALS materials. Allows tracking of product batch, review of shipping
SHIPMENT conditions, and accountability

NIH Guidelines for Conducting Research in MOH, 2021 49