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European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements." [1] Historically, TMFs have been paper-based content sets stored in physical file cabinets, central file rooms, or shelved in binders. The size and complexity ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
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.
The standards upon which this certification program is based have been set forth by this organization to promote recognition and continuing excellence in the ethical conduct of clinical trials. SOCRA provides training, continuing education, and a certification program.
Each submission message constitutes one "sequence". A cumulative eCTD consists of one or more sequences. While a single sequence may be viewed with web browser and the ICH stylesheet provided, viewing a cumulative eCTD requires specialized eCTD viewers. The top part of the directory structure is as follows:
The uptick in activity was largely driven by the services sector. The services component of S&P's report showed the index registered 57 this month, up from 55 in October and the highest level in ...
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
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