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The following list several of NCCR’s significant contributions:
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Established the guidelines for accreditation of clinical research centres |
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Developed and published the Malaysian Good Clinical Practice Guidelines |
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Developed the curriculum and requirement for conducting GCP training courses |
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Initiated and carried out a series of national GCP training course for trainer/clinical researcher |
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Established the procedure for the accreditation of clinical facilities to conduct GCP compliant studies |
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Undertook preliminary inspection visits to major hospitals/clinical facilities and advised on steps that needed to be carried out to attain compliance |
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Initiated and carried out introductory courses in Good Laboratory Practices |
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Developed the guidelines for the conduct of Bio-equivalence evaluation for the generic pharmaceuticals |
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Undertook a review of current practices for ethical approval in Malaysia and established mechanism to harmonize approval standard and procedures |
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Developed a series of guidelines for the conduct of clinical studies for herbal products. |
Guidelines
» Good Clinical Practice (GCP)
» Guideline on the Use of Human Biological Tissues for Research
» Guidelines for Ethical Review of Clinical Research or Research involving human subjects
» Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption, Edition 6.4
» Guidelines for GCP Inspection
» Malaysian Guideline for Safety Reporting of Investigational Products 1st Edition
» Malaysian Guideline for Independent Ethics Committee Registration and Inspection 1st Edition
» Malaysian Guideline for Bioequivalence Inspection, 1st Edition
For your convenience, we have the following guidelines featured as well:
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