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Article 58 requires that "the sponsor and investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial." This requirement defines a minimum retention period across the EU for all clinical trial master files, irrespective of whether the data subsequently supports a marketing ...
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
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FDA: Clinical trial endpoints for the approval of cancer drugs and biologics [17] provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications.
The International Clinical Trials Registry Platform (ICTRP) is a platform for the registration of clinical trials operated by the World Health Organization. [1]The ICTRP combines data from multiple cooperating clinical trials registries to generate a global view of clinical trials worldwide, with a search portal that allows access to the entire dataset.
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The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.
Clinical trials are used to gather statistical evidence about the effects of particular medical investigations or therapies. This category is for specific clinical trials and specific types of clinical trials. Use Category:Clinical research for articles which are about the field but not particularly about clinical trials themselves.