Malaysia Decentralised Clinical Trial (DCT) Guidance Document

Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling
Malaysia has released its first Decentralised Clinical Trial guidance document, which provides detailed guidance on implementing decentralised elements in clinical trials. The document was developed through collaboration between various stakeholders and can be used regardless of any health crisis. It is favourable to the industry and it is applicable now.
The document outlines how companies can incorporate DCT into their research while setting key parameters, rules and expectations.

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