eTrial Master File

The Trial Master File (TMF) contains those essential documents that individually and collectively permit the evaluation of how the trial was conducted and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice (GCP) and with all applicable regulatory requirements. All sponsors and investigators, as well as those conducting trials in academic research, are required to maintain documentation for each clinical trial.

KnowledgeNET enables the production of a regulatory compliant eTMF in accordance with 21 CFR Part 11. KnowledgeNET eTMF provides support in implementing an electronic centralized method of storing and archiving the TMF documents. KnowledgeNET also enables generation of a single electronic copy of the TMF which significantly reduces the need to print, replicate, distribute, consolidate and store multiple copies of the same documentation at different places.

KnowledgeNET for eTMF is equipped with customizable Trial Master File Templates which can be managed site wise, which can capture searchable document enabling instant access to all the stake holders and document owners of the Trial Management.

Also, KnowledgeNET facilitates remote management of documents, which saves administrative time and increases accuracy and security of records handling.

Salient Features:

• Site wise eTMF document management
• Paper and electronic archiving
• Reporting module based on access and content
• Results output as a single PDF
• User-friendly interface
• Document commenting
• Central repository of all the documents