Home About CRC Resources FAQs on CRC
Frequently Asked Questions on CRC Print

 

What does CRC generally do?

The Clinical Research Centre (CRC) is the clinical research arm of the Ministry of Health (MOH) and is responsible for conducting clinical trials, clinical epidemiology and economic research, and for managing complex medical databases. Under the purview of the National Institutes of Health (NIH), the CRC promotes, supports and conducts quality and ethical research to improve patient outcome. With a network of 17 centres around the country, the CRC acts as a One-Stop-Centre by providing a single point of contact to access all MOH hospitals and clinics nationwide.

 

Where are the 17 centres of the CRC?

Click here for the 17 centres of the CRC

Where is the main office of CRC located?

Click here for CRC Headquarters

How many units does CRC have now?

CRC has the three following units:
1. Clinical Epidemiology Unit (CEU)
2.
Clinical Trial Unit (CTU)
3.
Quality Assurance Unit (QA)

What kind of research is CRC involved in?

CRC conducts clinical trials, clinical epidemiology and economic research, and manage complex medical databases

Does CRC collaborate with the private sector?

Yes, especially on Clinical Trial

Does CRC conduct research for the researchers?

Yes it does, especially clinical research

Who do I send my resume to?

Send in your complete CV to This e-mail address is being protected from spambots. You need JavaScript enabled to view it and This e-mail address is being protected from spambots. You need JavaScript enabled to view it or you may contact anyone from the Human Resource Unit at Clinical Research Centre (CRC) main office.

What courses and workshops are conducted by CRC?

CRC offers Good Clinical Practice (GCP) workshops, Research Methodology and Biostatistics courses and medical writing training.
Click here for more CRC training and workshops

 

What is the latest news on CRC?

Click here for CRC updates and news on clinical research

 

How long does it take to do a clinical trial?

It depends on the drug, methodology and clinical trial phase. CRC conducts Phase II, III and IV trials

What is the cost of clinical trials conducted by CRC?

Please contact Pharmaceutical Research Unit at 03-40439300 or 0340439400 for further information and details on cost

How many clinical trials are conducted by CRC?

More than 400 trials were conducted between 2006 and Nov 2008

Does CRC have any guidelines on clinical trials in Malaysia?

The following are the Clinical Trials Guidelines used in Malaysia:

  1. Malaysian Guidelines for GCP

  2. ICH GCP 1996

  3. WHO GCP

  4. Declaration of Helsinki, 2000

  5. Nuremberg Code 1947

  6. The Belmont Report 1979

  7. International Committee of Medical Journal Editors (ICJME), October 2004

  8. ICH E2A

  9. ICH E2B

  10. ICH 2B(M)

  11. ICH 2C

  12. ICH 2C (Addendum)

  13. ICH E3

  14. ICH E9

Click here for more clinical research resources

Does CRC conduct research consultation?

Yes, CRC conducts an In-House weekly Research Consultative Clinics every Wednesday from 2:30 until 3:30 for the first session and from 3:30 until 4:30 for the second session

What type of consultancies does CRC offer the researchers?

CRC can assist researchers with the following:

  1. Literature review and critical appraisal

  2. Article search

  3. Study design planning

  4. Sample size planning

  5. Proposal/protocol development

  6. Grant submission

  7. Project Management planning

  8. Data Management

  9. Statistical analysis

  10. Other related services

 

Are there any CROs in Malaysia?

Yes there are - MySMO, MDS Pharma Services, Apex International, Protech Pharmaservices Corporation (PPC), Info Kinetics, ClinResearch Sdn Bhd, Quintiles (M) Sdn Bhd, Progenix Research Sdn Bhd, Apex Malaysia Sdn Bhd etc

 

Who do I contact for enquiries?

Contact details for enquiries:
General Line: 603-26980310/603-26924249/603-26911486
Fax: 26911682
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FAQs on MySMO

What is the difference between CRC and MySMO?

MySMO undertakes site management organisation operations on behalf of CRC


Is MySMO a Private company?

Yes, it is


What are the requirements to start a stem-cell clinical trial in Malaysia?

Contact Ms Iris Tan, Business Development Manager for MySMO, for further details. Please note that stem-cell clinical trials must go through phase 1

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FAQs on NMRR

What is NMRR all about?

National Medical Research Register (NMRR) is a web-based tool designed to support the implementation of the National Institute of Health (NIH) guideline on the conduct of research in the Ministry of Health Malaysia (MOH)

Why NMRR?

NMRR facilitates and promotes a one stop agency for Clinical and Non Clinical Research by MOH. In addition, NMRR enables Management to document the level of research activity in the MOH and to track progress of the research approved, supported or funded by MOH. All registered research, especially clinical trials, will be published in the Directory of Medical Research, Malaysia and the Directory of Clinical Investigator & Medical Researchers, Malaysia

Why Register in NMRR?

Under the new NIH Guidelines, MOH requires its research to be registered in NMRR. Also, registration is required for publication of research results generated from the MOH.

In addition, with NMRR, the public is aware and have access to clinical trials and other medical research

Do I have to register in NMRR if I am conducting a clinical trial?

Yes, especially if the research is a Ministry of Health (MOH) research

Does the investigator or sponsor need to register with NMRR?

Investigators have to register with NMRR not a sponsor

How do I contact the NMRR secretariat and MREC secretary?

NMRR Secretariat :+( 603)-2698 0310
NMRR IT Admin: + (603)-4044 0615
MREC Ethics Approval Secretary: + (603)-2287 4032
Monday to Friday from 8:30am – 5:00pm
Log on to www.nmrr.gov.my< for more information

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FAQs on pharmaceutical research

What is PRU in CRC?

The PRU was re-fashioned from its forerunner; the Clinical Trial Unit in CRC, with a broadened scope of research interests and capabilities. This was in response to increasing demands from clinicians and managers from both public and private sectors for reliable data on the use, availability and access to medicines and medical devices in the country; their associated costs, and clinical and cost-effectiveness of these therapeutics in real-world healthcare setting in Malaysia

Who does PRU collaborate with?

The PRU collaborates with clinicians, pharmacists, managers and industry on a variety of projects to increase understanding of existing problems related to use, safety and cost of medicines and medical devices

What are the clinical trial services provide by PRU?

PRU offer comprehensive clinical trial services in support of Phase II and III studies, which provide the basis for regulatory approval of new pharmaceuticals and medical devices. PRU also supports phase IV studies to explore new indications, to enable early clinical experience, to evaluate treatment effectiveness in everyday clinical setting and post- marketing pharmacovigilance

How do I contact the PRU?

Pharmaceutical Research Centre
Level 3, MMA House,
Jalan Pahang,
53000 Kuala Lumpur
Malaysia
Phone: +603-40439400
Fax: +603-40439500
Website: www.crc.gov.my

Click here for more information on pharmaceutical research

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FAQs on patient registries and clinical epidemiology

How do we set up a new registry and apply for grant?

All registries are set up by the Ministry of Health (MOH) and there are no individual grants for registry

What are Patient Registries?

Patient Registries and Clinical Database is an organized system that uses observational study methods to collect uniform data (clinical and others) to evaluate specified outcomes for a population defined by a particular disease or therapy, and that serves one or more predetermined scientific, clinical, or policy purposes

What is the function of the Clinical Epidemiology in CRC?

The Clinical Epidemiology (CEU) in CRC was established in response to the increasing demand from clinicians, health managers and policy makers for pertinent information that only clinical epidemiology research could provide

What is the objective of Patient Registry and Clinical Databases?

There are four common objectives:

  1. To describe the natural history of the target disease; to describe the characteristics of patients, their management, and patient survival and quality of life outcomes with and/or without treatment.

  2. To determine clinical and cost effectiveness of treatments for the target disease in real world clinical practices in Malaysia

  3. To monitor safety and harm of products and services used in the treatment of target disease

  4. To evaluate the access to and quality of treatment services for target disease

 

What is the latest report on each registry and how often is the information updated?

The latest softcopy report is always uploaded to the website and it is can be freely downloaded. Click here for these reports.

The hardcopies are reserved for the stakeholders of CRC and the Network of CRC


How do I contact the CEU?

Clinical Epidemiology Unit,
Clinical Research Centre
1st Floor, MMA House 124,
Jalan Pahang,
53000 Kuala Lumpur
Tel: +603-4044 3060 / +603-404430700
Fax: +603-40443080
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it


Click here for more information on clinical epidemiology
Click here for more information on patient registries


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 

FAQs on Medical Devices

What is NMDS?

The National Medical Device Survey (NMDS) is a service initiated and supported by the Ministry of Health (MOH) to collect information on the supply procurement and utilization of Medical Device in Malaysia

What is NMDS design to?

The NMDS are designed to:

  1. Quantify the current trends of the availability and utilization of medical devices at various level of our health care system, whether national, regional, local or institutional

  2. Establish collaborate efforts to better understand Medical device use in its clinical environment

  3. Support the implementation of Malaysia’s proposed regulatory system for medical devices

  4. Provide a setting for applied clinical and epidemiological research on medical devices issues

 

If I am interested in research involving medical devices, how do I go about it and who do I contact?

Please contact Dr Ariza Zakaria at 603-40439300 / 603-40439400 for more information

What is NMUS?

The National Medicines Use Survey (NMUS) is a service initiated and supported by the Ministry of Health (MOH) to collect information on the supply, procurement, prescription, dispensing and use of drugs in Malaysia

What are the benefits of participating in NMUS?

Apart from doing your bit for your community, here are some other benefits of being a participant:

  1. Invitation to all functions organized by the NMUS

  2. Invitation to scientific meetings on the quality use of medicines organized by NMUS with registration fees waived

  3. Acknowledgement in all NMUS publications

  4. Free copy of all NMUS publications

  5. Free access to all reports and other information published by NMUS in its website

  6. Free listing in the “The Malaysian Medical & Health Directory” or “Medicines Information Project” where applicable.

  7. Free listing in the NMUS’s web site

  8. Opportunity to participate in further research on drug utilizations to investigate the hypotheses generated by NMUS data

  9. Tap into a network of like-minded people from diverse professional disciplines and backgrounds

 

What is MSM?

MSM is Medical Statistics of Medicine under National Medicine Use Survey project conducted by Clinical Research Centre (CRC)

Is the MSM 2005 for sale

No, but it can be downloaded for free at this link
http://www.crc.gov.my/nmus/documents/msmreport_2007.pdf

How do I contact the NMUS?

National Medicine Used Survey c/o Pharmaceutical Research Unit
Tel: +603-40439300 / +603-40439400
Fax: +063-40439500
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Website: http://www.crc.gov.my/nmus

 
Last Update 21 July 2010

Site Log (click here for latest site updates)