Page 81 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

F. INVESTIGATOR’S BROCHURE (IB)
21 Investigator’s Brochure The content/format of IB should follow section
7.5 (Appendix 2) page 71 Malaysian Guideline for
(The IB is a requirement for herbal GCP 3rd edition

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test item(s) going for c clinical trials)
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TITLE PAGE (Example)
TITLE OF STUDY
Sponsor’s Name:
Product:
Research Number:
Name(s) Chemical, Generic (if approved)
Trade Name(s) (if legally permissible and desired
by the sponsor)
Manufacturer:

INVESTIGATOR'S BROCHURE
Edition Number:
Release Date:
Replaces Previous Edition Number:
Date:

CONTENTS OF INVESTIGATOR'S BROCHURE
(Example)
CONFIDENTIALITY STATEMENT (optional)
SIGNATURE PAGE (optional)
TABLE OF CONTENTS
SUMMARY (preferably not exceeding two pages)
1.0 INTRODUCTION
1.1 References
2.0 PHYSICAL, CHEMICAL, AND PHARMACEUTICAL
PROPERTIES AND FORMULATION
2.1 Introduction
2.2 Product description (eg: (invented) name of
medicinal product, strength, pharmaceutical
form)
2.3 Manufacturing of Product (eg: GMP
certificate)
2.4 Quality Control Tests (eg: In-Process Quality
Control (IPQC), Finished Product Quality Control
(FPQC))
2.5 Quality Assurance
2.6 Stability (eg: Container closure system,
storage condition, proposed shelf-life)
2.7 Attachments (may include certificate of
analysis)
NRDHM HERBAL TEST ITEM FOR STUDIES Ver3.1 Mar2015 5

NIH Guidelines for Conducting Research in MOH, 2021 65