Cybermed Update August 2002
- If we knew what it was we were doing, it would not be called research, would it?
Albert Einstein (1879 - 1955)
CLINICAL TRIAL INFORMATION IN MALAYSIA
This article is highlighting sites in Malaysia where one can get information pertaining to clinical trials. It will cover clinical trial sites, information on clinical trial import license, IRB's, etc. Malaysia has in place GCP guidelines and in many of the institutions SOP's are available for the proper conduct of clinical trials.
Lets start from the beginning.....
National Pharmaceutical Control Bureau, MOH (NPCB)( http://www.bpfk.gov.my/ )
One of the best and most comprehensive site for information pertaining to registration of drugs, cosmetics, herbal preparation, etc as well as permit to import license. Documents are available in pdf as well as word document to download and use for submission. Other information found at this site includes MADREC (Malaysian Adverse Drug Reaction Advisory Committee), information on registered products, change of labeling information and much, much more. Permit to import license and IRB submission to various institutions can be submitted in parallel but permit will only be issued after approval from IRB. You can download from this site among others...
- Application forms in Bahasa Malaysia
Institute of Medical Research, MOH ( http://www.imr.gov.my/ )
Unfortunately this site was down for maintenance at the time of writing this article. Information on when the standing committee for research and ethics meet, documents for submission, composition of the committee, grant application, etc is available at this site.
Clinical Research Center, Ministry of Heath ( http://www.crc.gov.my/index.htm )
CRC is the clinical research arm of the Ministry of Health Malaysia. They conduct clinical trial, health outcomes, clinical economics, epidemiology research, and clinical practice evaluation studies. CRC is located in the Kuala Lumpur Hospital. They support the following registries: National Renal Registry, National Cancer Registry, National Cataract Surgery Registry, National Trauma Registry and the National Neonatal Registry. In addition they conduct Good Clinical Practice workshops and training courses for clinical researchers. A must visit site!
Clinical Investigation Centre, University of Malaya ( http://www.ummc.edu.my/fom/cic/ )
Probably the first center to be setup and to have a website. The site was down for awhile but has recently been resuscitated. Ethics commitee composition and application forms available. Date of Medical ethics commitee meeting not available.
Clinical Trial Unit, University Sains Malaysia ( http://www.usm.my/p&p/ )
I must say that this site although very recently setup has been fairly informative.
University Kebangsaan Malaysia ( http://research.ukm.my/ )
Unlike the previous sites, no direct link to a clinical trial unit although one is available. Home page should have an english version available for overseas companies looking at the site to do research.
International Medical University ( http://www.imu.edu.my )
Another site that does clinical trials but no web page with a direct link to this information.
In general, all sites should have application forms for submission to their local ethics/IRB available as well as flow charts for downloading at their web site along with scheduled dates of these meetings. They should take a look at other centers around the world and see how best they can update their information.
With that I let your "mouse" or your "keyboard" do the "talking".
Till next month, "Happy Surfing".
Cyberdoc ( email@example.com )
The links to URL mentioned above are valid at the time of writing (9 September 2002).
Last updated 15th January 2006.
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