Clinical Trial Guidelines
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WMA Declaration of Helsinki 2008- CIOMS 2002. International Ethical Guidelines for Biomedical Research Involving Human Subjects
- WHO 2000. Operational Guidelines for Ethics Committees That Review Biomedical Research
- ICH E9 : Statistical Principles for Clinical Trials
- ICH E3 : Structure & Content of Clinical Study Report
- ICH 2C (Addendum) :Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drug
- ICH 2C : Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs E2C
- ICH 2B(M) : Maintenance of the ICH Guideline on Clinical Safety Data Management
- ICH E2B : Data Elements for Transmission of Individual Case Safety Reports.
- ICH E2A : Clinical Safety Data Management: Definitions & Standards for Expedited Reporting E2A
- International Committee of Medical Journal Editors (ICJME), October 2004
- The Belmont Report 1979
- Nuremberg Code 1947
- WHO GCP
- ICH GCP 1996
- Borang Permohonan Kelulusan Menerbitkan Hasil Penyelidikan / Kajian
- Surat Pekeliling Ketua Pengarah Kesihatan Malaysia Bil.9/2007 (English version)
- Surat Pekeliling Ketua Pengarah Kesihatan Malaysia Bil.9/2007 (Malay version)
