Quality Assurance Unit

VISION
To be a Catalyst for the Conduct of Quality and Ethical Clinical Research.

MISSION
Initiate and Coordinate Implementation of Quality Systems towards the Enhancement of Clinical Research at the Ministry of Health Malaysia.

OBJECTIVES

1. Research
   

   1.1	Plan and conduct studies on quality aspects of Clinical Research.

2. Service
   

   2.1	Improve the quality of clinical research through development, dissemination, implementation, and training on use of research standard operating procedures (SOPs).
   2.2	Audit quality of Clinical Research activities such as conduct of research, training and human resource development, and dissemination of research results.

3. Consultation
   

   1.1	Provide advice in the development and implementation of quality systems for Clinical Research.

4. Training
   Provide training in the following:

   4.1	Implementation and use of research SOPs.
   4.2	Registration of research proposals in the National Medical Research Registry.
   4.3	Development of research SOPs.
   4.4	Implementation of quality systems for Clinical Research.

Organization Chart (QA)

Research (QA)

1. COMPLETED RESEARCH
   

   1.1	Retrospective study of approval time by Medical Research & Ethics Committee (MREC) for Postgraduate Masters Proposal (PMP) In 2012. This project was initiated to investigate the cumulative approval time (CAT) and completion time of each phase of approval of PMP approved in the National Medical Research Register (NMRR) in 2012.
   1.2	Overview of potential risks and benefits assessment models. This study was initiated to review currently available models for the assessment of risks and benefits of clinical research that involves human subjects.
   1.3	Pilot study for new framework for research approval in MOH. This study was initiated to establish new framework to review research proposal with minimal risk at hospital level to shorten research approval time in MOH.

2. ON-GOING RESEARCH
   

   2.1

   A retrospective Good Clinical Practise (GCP) compliance analysis of protocols and informed consent forms of postgraduate Masters of Medicine (MMed) research projects in the Ministry of Health (ID:NMRR-13-9-14686). This project was initiated to study the GCP compliance of protocols and informed consent forms of postgraduate medical research projects approved in the National Medical Research Register (NMRR) in 2012.

   2.2

   Retrospective study of approval time by Medical Research & Ethics Committee (MREC) for Postgraduate Masters Proposal (PMP) In 2013. This project was initiated to investigate the cumulative approval time (CAT) and completion time of each phase of approval of PMP approved in the National Medical Research Register (NMRR) in 2013 to evaluate whether improvement made in NMRR resulted in PMP approval time.

Services (QA)

1. The Quality Assurance Unit provides the following consultations to assist MOH investigators/researchers in their clinical research:
   

   1.1	Preparation and implementation of clinical research standard operating procedures (SOP).
   1.2	Preparation of research protocol and informed consent form.
   1.3	Application for ethics approval for research involving human subjects.

2. The Unit provide trainings on:
   

   2.1	CRC Research Management ISO Standards.
   2.2	NMRR User and Research Registration.
   2.3	Scientific and ethical review of research protocols and informed consent forms.
   2.4	Various aspects of Malaysian Good Clinical Practice Guidelines.

3. The Unit is the Secretariat of the Scientific Review Board of the National Clinical Research Centre (NCRC) and is responsible for the management of review and approval of protocols of research conducted by staff of NCRC.

Address:
QUALITY ASSURANCE UNIT
Clinical Research Centre
Level 3, MMA Building
Jalan Pahang
53000 Kuala Lumpur, Malaysia.
Tel: 603-40439300/40439400/40447001/40438001
Fax: 603-40439500
Email: contact@crc.gov.my