Page 63 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

APPENDIX 3: ESSENTIAL DOCUMENTS IN FILES OF RESEARCHER/INSTITUTION

Initial Submission prior to the study commencement
During this planning stage the following documents should be generated and should
be on file of investigators/institution before the trial/research formally starts:

Document Purpose

1. INVESTIGATOR’S BROCHURE To document that relevant and current scientific information
(where applicable) about the investigational product has been provided to the
investigator
3. SIGNED PROTOCOL AND To document investigator and sponsor agreement to the
AMENDMENTS, IF ANY, AND protocol/amendment(s) and CRF
SAMPLE CASE REPORT FORM
(CRF)
4. INFORMED CONSENT FORM To document the informed consent
(including all application
translation)
5. ANY OTHER WRITTEN To document that subjects will be given appropriate written
INFORMATION information (content and wording) to support their ability to
give fully informed consent
6. ADVERTISEMENT FOR To document that recruitment measures are appropriate and
SUBJECT RECRUITMENT (if used) not coercive
7. FINANCIAL ASPECTS OF THE To document the financial agreement between the
STUDY (where applicable) investigator/institution and the sponsor for the trial
8. INSURANCE STATEMENT To document that compensation to subject(s) for trial-related
(where required) injury will be available

9. SIGNED AGREEMENT To document agreements
BETWEEN INVOLVED
PARTIES (where applicable)
10. DATED, DOCUMENTED To document that the trial has been subject to IRB/IEC review
APPROVAL/ FAVOURABLE and given approval/ favourable opinion. To identify the version
OPINION OF INSTITUTIONAL number and date of the document(s)
REVIEW BOARD (IRB)/
INDEPENDENT ETHICS
COMMITTEE (IEC) (where applicable)
11. REGULATORY AUTHORITY(IES) To document appropriate authorization/approval/notification
AUTHORIZATION/ APPROVAL/ by the regulatory authority(ies) has been obtained prior
NOTIFICATION OF PROTOCOL to initiation of the trial in compliance with the applicable
(where required) regulatory requirement(s)
12. CURRICULUM VITAE AND/ To document qualifications and eligibility to conduct
OR OTHER RELEVANT trial and/or provide medical supervision of subjects
DOCUMENTS EVIDENCING
QUALIFICATIONS OF
INVESTIGATOR(S) AND
SUBINVESTIGATOR(S)

NIH Guidelines for Conducting Research in MOH, 2021 47