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Version No: 1.0 / Clinical Research Centre / Page 1 of 11
Ver.Date:<dd/mm/yyyy> / Contract and Grant Administration / SOP-R-ISR-1-01

Property of CRC

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

The Director, Clinical Research Centre

Standard Operating Procedure

Contract and Grant Administration

Document number: / SOP-R-ISR-1-01
Date registered: / <dd/mm/yyyy>
Revision number: / 0
Date revised:
Version number: / 1
Date of version: / <dd/mm/yyyy>
Electronic hyperlink:
Number of pages: / 11
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

#

/ /

Page #

REVISION HISTORY

TABLE OF CONTENTS /

/ PURPOSE /

/ SCOPE /

/ ABBREVIATIONS /

/ GLOSSARY /

/ RESPONSIBILITY /

/ REQUIRED AND RELATED DOCUMENTS /

/ PROCEDURE /

4-5

/ FLOWCHART /

/ REFERENCE /

/ APPENDIX 1 Letter of Intent for Payment Instruction (CRM)
APPENDIX 2 Payment Instruction Form (CRM) /

8-11

1. Purpose

This standard operating procedure (SOP) describes the procedures to receive and manage research contract and grant from industry. The procedures in this SOP are specific for industry sponsored research (ISR) and are continuity from Study Feasibility Assessment SOP.

2. Scope

This SOP applies to all ISR that involves MOH personnel and/or that is to be conducted in MOH facility.

3. ABBREVIATIONS

CRC / Clinical Research Centre
CRM / Clinical Research Malaysia
CRO / Contract Research Organisation
CTA / Clinical Trial Agreement
DI / Director of Institution
HOD / Head of Department
ISR / Industry Sponsored Research
LOI / Letter of Intent
MOH / Ministry of Health
MREC / Medical Research & Ethics Committee
NMRR / National Medical Research Registry
PI / Principal Investigator
PIF / Payment Instruction Form
SOP / Standard Operating Procedure
TP / Template
WI / Work Instruction

4. Glossary

Term / Definition
Contract / A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract1-2.
Contract Research Organisation / A person or an organisation (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions1-2.

5. Responsibility

Principal investigator (PI) is responsible for the execution and administering of contract; and is ultimately responsible for the performance and supervision of a clinical trial. The PI may delegate some tasks to co-investigators or staff, but remains responsible at all times for the conduct of all individuals involved in the research.

CRM’s legal advisor is responsible to check the content of clinical trial agreement (CTA) and other relevant supporting documents before recommending PI to submit contract to head of department (HOD) and Director of Institution (DI) for approval

The HOD of PI is responsible for verifying the content of CTA and other relevant supporting documents before forwarding them to DI for approval. It is the responsibility of DI to decide whether the CTA and other relevant supporting documents are acceptable for approval.

Sponsor or clinical research organization (CRO) may assist PI to register project in National Medical Research Registry (NMRR) to obtain ethical approval from Medical Research & Ethics Committee (MREC).

6. REQUIRED and related DOCUMENTs

# / Document title
/ SOP-R-ISR-1-03: NMRR Registration for ISR
/ TP-ISR-1-01-01: CTA Template (CRC)
/ WI-ISR-1-01-01: Work Instruction for Contract and Grant Administration

7. PROCEDURE

Step # / Process / Responsibility
/ Receives agreement and other relevant document(s) from sponsor/CRO. Refers WI-ISR-1-01-01 for guidance to manage contract and grant. / PI
/ Checks the content of agreement and other relevant document(s) by referring to TP-ISR-1-01-01. / PI/CRM’s legal advisor
/ Forwards agreement and other relevant document(s) to HOD for content’s verification. / PI
/ Verifies contents of submitted agreement and other relevant document(s):
a) If no concern, forwards to DI and proceeds to next step;
OR
b) If have concern but the concern can be resolved, informs PI to discuss with sponsor/CRO and makes necessary revision and resubmits to HOD;
OR
c) If have concern but the concern cannot be resolved, rejects the agreement and informs PI the procedure ends. / HOD
/ Examines contents of submitted agreement and other relevant document(s) and decides:
a) If no concern, signs the agreement and reverts back to PI and proceed to next step;
OR
b) If have concern, informs PI through HOD to discuss with sponsor/CRO and makes necessary revision and resubmits to HOD;
OR
c) If have concern but the concern cannot be resolved, rejects the agreement and informs PI the procedure ends through HOD. / DI
/ Reverts back the signed agreement and other relevant document(s) to sponsor/CRO. / PI
/ Registers project in NMRR to obtain ethical approval from MREC by referring to SOP-R-ISR-1-03. / Sponsor/CRO/PI
/ Makes arrangement with Clinical Research Malaysia (CRM) to receive fund from sponsor/CRO. / PI
/ Receives fund from sponsor/CRO through CRM and initiates study. / PI

8. FLOWCHART

9. REFERENCES

1) Guideline For Good Clinical Practice E6 (R1)

(

2) Malaysian Guideline For Good Clinical Practice (3rd Edition)

(http://www.crc.gov.my/pdf/GCP2_11.pdf)

3) Letter from Director General of Health to Sponsor on Management Fees for Industry