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GOOD CLINICAL PRACTICE (GCP)
By Dato’ Dr Ismail Merican The Ministry of Health (MOH) together with the WHO Special Programme for Research and Training in Tropical diseases (WHO-TDR) recently organised a hands-on 7-day workshop on Good Clinical Practice (GCP). The workshop was officiated by Y. Bhg. Tan Sri Dato ' Dr Abu Bakar Suleiman, the Director-General of Health. At the ceremony, Tan Sri Dr Abu Bakar also launched the Malaysian Guidelines for Good Clinical Practice (GCP) and Guidelines for Application to Conduct Drug-Related Clinical Trials in Malaysia. Both books are available for all those interested in doing clinical research in Malaysia and tunding agencies, sponsors or pharmaceutical companies who wish to conduct drug-related clinical trials in any of the research institutions in this country. There have been a number of concerns regarding timelines and procedures related to clinical research and the Steering Committee on Clinical Trials in Malaysia hopes that the availability of these 2 useful documents will help to facilitate clinical research in the country.It is important for all clinicians to be aware of GCP before embarking on any clinical research.
What is GCP?
Good Clinical practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected.GCP ensures that subjects are properly protected in clinical studies. Such studies should be based on good science, are well designed and properly analysed and adhere to procedures that are properly undertaken and documented. Adherence to GCP is vital otherwise, subjects participating in the trials may be put at risk or the clinical trial data submitted may be rejected by health authorities and the scientific committee, if found to be unreliable. Also, the research
By Dato’ Dr Ismail Merican The Ministry of Health (MOH) together with the WHO Special Programme for Research and Training in Tropical diseases (WHO-TDR) recently organised a hands-on 7-day workshop on Good Clinical Practice (GCP). The workshop was officiated by Y. Bhg. Tan Sri Dato ' Dr Abu Bakar Suleiman, the Director-General of Health. At the ceremony, Tan Sri Dr Abu Bakar also launched the Malaysian Guidelines for Good Clinical Practice (GCP) and Guidelines for Application to Conduct Drug-Related Clinical Trials in Malaysia. Both books are available for all those interested in doing clinical research in Malaysia and tunding agencies, sponsors or pharmaceutical companies who wish to conduct drug-related clinical trials in any of the research institutions in this country. There have been a number of concerns regarding timelines and procedures related to clinical research and the Steering Committee on Clinical Trials in Malaysia hopes that the availability of these 2 useful documents will help to facilitate clinical research in the country.It is important for all clinicians to be aware of GCP before embarking on any clinical research.
What is GCP?
Good Clinical practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected.GCP ensures that subjects are properly protected in clinical studies. Such studies should be based on good science, are well designed and properly analysed and adhere to procedures that are properly undertaken and documented. Adherence to GCP is vital otherwise, subjects participating in the trials may be put at risk or the clinical trial data submitted may be rejected by health authorities and the scientific committee, if found to be unreliable. Also, the research
Links: to the compliance programs for each inspection type and contact information for each Center’s BIMO program are also accessible from this site.Office of Good Clinical PracticeSee the Office of Good Clinical Practice’s (OGCP’s) mission statement on the OGCP 's Web page. In June 2009, FDA redesigned its web site. As a result, some links (URLs) embedded within Guidance documents, Rules, and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document’s title. For additional assistance, go to Contact FDA. We apologize for any inconvenience this redesign might have caused. | | * Bottom of Form