21 June 2017
Traditionally, data management related documentation is stored in Data Management Master File.
Nowadays, regulatory authorities recommend implementing standard approach to every step of a clinical trial process. This is to ensure smooth cooperation between all participants and reduce costs.
Professionals worldwide unite into non-profit associations, such as CDISC or DIA. They develop the industry standards that service providers would follow and accept as best practice.
Data Management 365 is a provider of clinical DM services. We work with pharma and CRO customers who bear overall responsibility for the conduct of a clinical trial, while we remain focused on our specific area.
So, we thought it would be a good idea to send DM archive to our customer as a bit they could easily build into the Trial Master File at the end of the study.
We decided to take the DIA’s current TMF Reference Model as guidance and implemented an eTMF solution provided by Flex Databases. The eTMF structure is study specific, with appropriate template version control, naming conventions and indexing.
We encourage our clients that we share the same eTMF, thus allowing for easier review and controlled access to documents.
However, even if our client maintains the TMF in a different system but uses the same standard file structure as we do, it is quite a simple exercise to incorporate the DM-related part seamlessly into the master file, at any stage.
We strongly believe that sound practices help ensure good quality of the service we provide and we do our best for customers’ satisfaction.