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The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare,made to enable information system interoperability and to improve medical research and related areas of healthcare.
Examples of data that would lead to a query: a male patient being on female birth control medication or having had an abortion, or a 15-year-old participant having had hip replacement surgery. Each query has to be resolved by the individual attention of a member of each local research team, as well as an individual in the study administration.
A data clarification form (DCF) [1] or data query form is a questionnaire specifically used in clinical research. The DCF is the primary data clarification tool from the trial sponsor or contract research organization (CRO) towards the investigator to clarify discrepancies and ask the investigator for clarification. The DCF is part of the data ...
Article 57 of the Regulation requires that the TMF "shall at all times contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated", confirming that the trial master file should be maintained contemporaneously.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
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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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