Version No: 1.0 / Clinical Research Centre / Page 1 of 7
Date: <dd/mm/yyyy> / NMRR Registration for ISR / SOP-R-ISR-1-03

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May not be used, divulged, published or otherwise disclosed without the consent of

The Director, Clinical Research Centre

Standard Operating Procedure

National Medical Research Register (NMRR) Registration for Industry Sponsored Research (ISR)

Document number: / SOP-R-ISR-1-03
Date registered: / <dd/mm/yyyy>
Revision number: / 0
Date revised:
Version number: / 1
Date of version: / <dd/mm/yyyy>
Electronic hyperlink:
Number of pages: / 7
Control status: / CONTROLLED
Controlled copy number: / Master
Document author(s): / Reviewed and approved by
Signature:______
<Name>
Date: <dd/mm/yyyy> / Signature:______
<Name>
Date: <dd/mm/yyyy>

REVISION HISTORY

Rev # / Section / Revision Date / Reason for Revision / Signature of Head Of QA Unit

TABLE OF CONTENTS

#

/ /

Page #

/

REVISION HISTORY

/

1

TABLE OF CONTENTS /

2

/ PURPOSE /

3

/ SCOPE /

3

/ ABBREVIATIONS /

3

/ GLOSSARY /

3-4

/ RESPONSIBILITY /

4

/ REQUIRED AND RELATED DOCUMENTS /

4

/ PROCEDURE /

4-5

/ FLOWCHART /

6

/ REFERENCE /

7

/

APPENDIX

/

7

1. Purpose

This standard operating procedure (SOP) is for the registration of Industry Sponsored Research (ISR) in the Ministry of Health (MOH) National Medical Research Register (NMRR) prior to the conduct of proposed study. It is a directive of the Director-General of Health, MOH, that all research conducted in MOH facilities must be registered in the NMRR1,2.

NMRR is a web-based tool accessible at www.nmrr.gov.my and designed to enable the following:

  • On-line registration of research;
  • On-line application for ethical approval from the Medical Research & Ethics Committee (MREC)1,2;
  • On-line submission for review by NIH reviewers for research conducted by non-NIH investigator1,2;
  • On-line application for MOH-NIH Research Grant (MRG); ethical approval from MREC for research involving human subjects;
  • Online application for approval to publish research findings;
  • Preparation of reports on research conducted in MOH facilities; and
  • Tracking the progress of the registered research.

2. Scope

This SOP applies to all industry sponsored clinical research that involves MOH personnel or that is to be conducted in MOH facility.

3. ABBREVIATIONS

CP / Corresponding Person
CRC / Clinical Research Centre
CRO / Contract Research Organization
CV / Curriculum Vitae
DI / Director of Institute
GCP / Good Clinical Practice
HOD / Head of Department
IA-HOD-IA / Investigator's agreement-Head of Department-Institutional approval
ISR / Industry Sponsored Research
MOH / Ministry of Health
MREC / Medical Research and Ethics Committee
NIH / National Institutes of Health
NMRR / National Medical Research Registry
PI / Principal Investigator
SOP / Standard Operating Procedure

4. GLOSSARY

Term / Definition
Corresponding person / Individual who is registered as a NMRR user and who registers a research in NMRR. This is the person that NMRR will communicate with in all matters pertaining to the registered research.
Industry Sponsored Research / Industry Sponsored Research is research funded by a partner (a company, organisation or not-for-profit) without the need for a grant application or tender. The partner may define the objectives and is likely to have specific outcomes in mind and delivers value to the industry partner with payments linked to milestones.
Protocol / A document that describes the objective(s), design, methodology, statistical considerations, and organization of a research. The protocol also gives the background and rationale for the research; such information may be available from other supporting documents of the research.

5. RESPONSIBILITY

All investigators in the research team are responsible for registering for their own NMRR account. Principal Investigator (PI) is responsible for ensuring that all research documents are complete and correct before instructing registration of the research by the Corresponding Person (CP). The use of the term “Investigator” in item 7 of this SOP includes the person instructed by the investigator to register a research.

6. REQUIRED AND RELATED DOCUMENT

# / Document Title
/ WI-ISR-1-03-01 / : Work Instruction for National Medical Research Registry (NMRR) Registration of Industry Sponsored Research (ISR)
/ WS-ISR-1-03-01 / : Checklist of Required Information and Documents for National Medical Research Registry (NMRR) Registration of Industry Sponsored Research (ISR)

7. Procedure

Step # / Process / Responsibility
1. / Prepares the required document for registration by referring to WS-ISR-1-03-01. / Investigator
2. / Go to NMRR website at www.nmrr.gov.my:
a) If already has NMRR account, go to step 5;
OR
b) If does not have NMRR account, go to step 3. / Investigator
3. / Clicks CREATE A NEW ACCOUNT and input all required information and upload all essential documents and click SUBMIT (refer NMRR user guide3). / Investigator
4. / Receives NMRR email notification of creation of NMRR account creation and account password. / Investigator
5. / Logs into NMRR account, click “Industry Sponsored Research (ISR)” and complete the sections that appear (refer to WI-ISR-1-03-01). Click SUBMIT when all information have been inputted and uploaded. Person who keys in submission will be designated as “Corresponding Person (CP)” by NMRR system.
a) Complete mandatory sections 1 to 6.
Section 1: ENTER TITLE AND SELECT PURPOSE
OF SUBMISSION
Section 2: CRO
Section 3: SPONSORS
Section 4: INVESTIGATORS
Section 5: CORRESPONDING PERSON
Section 6: RESEARCH REGISTRATION
b) OPTIONAL: Complete section 7.3 if research involves human subject and thus require MREC.
Section 7.3: RESEARCH SUBMISSION FOR MREC
REVIEW & APPROVAL / Investigator
6. / Receives NMRR email acknowledging receipt of submission. / CP
7. / Receives NMRR notification:
a) If submission is complete, go to step 8;
OR
b) If a submission is incomplete, go to step 5 and submit information and/or documents requested by NMRR secretariat. / CP
8. / Receives NMRR ID. / CP

8. FLOWCHART

  1. REFERENCE

1) MOH DG Circular on NIH Guidelines for Conducting Research in The MOH Institutions and Facilities

(https://www.nmrr.gov.my/doc/001%20Surat%20Pekeliling%20KKM%20Bil%209_2007.pdf)

2) NIH Guidelines for Conducting Research in The MOH Institutions and Facilities (https://www.nmrr.gov.my/doc/01_NIH_Guidelines_for_Conducting_Research_in_MOH_v2_2_03March2008.pdf)

3) Instruction for Users Investigator or Researcher Registration

(https://www.nmrr.gov.my/doc/user_instruction_investigator_regsitration.pdf)

  1. APPENDIX

None