Guidance and guidelines
- International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) – an international ethical and scientific quality standard that stipulates the responsibilities of researchers, industry sponsors and ethics committees in the conduct of clinical trials.
- Malaysian Guideline for Good Clinical Practice (Malaysian GCP) (2018) – adapted from the ICH GCP to suit the Malaysian research environment.
- A guide to conducting clinical trials in Malaysia (2016) – a concise directory of all the authorities involved in regulating clinical trials in Malaysia. Also provides guidance on clinical trial agreements, trial budgeting and insurance / indemnity. (NOTE: Contact details and regulatory requirements could have changed since the publication of this document.)
Support organisations
- Clinical Research Malaysia (CRM) – a governmental organisation that facilitates industry-sponsored clinical trials under the Ministry of Health. Provides legal review and endorsement of Clinical Trial Agreements (CTA). Supports sponsors and researchers through investigator matching, budget management and other services.
- UMMC Clinical Investigation Centre (CIC) – organisation that supports both industry-sponsored trials (IST) and investigator-initiated trials (IIT) in UMMC. Provides comparable services to the CRM such as sponsor-investigator matching, legal review of CTA, financial advice, insurance for trial subjects, facilities support, etc. All clinical trials in UMMC have to be endorsed by the CIC.