Trial master file

<p>In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today takes the form of an <a href="/facts/Electronic_trial_master_file/pRmKg9G7">electronic trial master file</a> (eTMF). The <a href="http://www.ich.org/">International Conference on Harmonization (ICH)</a> published a consolidated guidance for industry on <a href="/facts/Good_Clinical_Practice/8b9gcE2h">Good Clinical Practice</a> in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. This guidance document established the requirement across all ICH regions to establish trial master files containing essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.<a href="http://ec.europa.eu/health/files/eudralex/vol-10/3cc1aen_en.pdf">[2]</a> In some jurisdictions, for example the USA, there is no specific requirement for a trial master file. However, if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.<a href="http://ec.europa.eu/health/files/eudralex/vol-10/3cc1aen_en.pdf">[2]</a>
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Trial master file open-in-new

Trial master file