Use of the DIA TMF Reference Model by CROs

Here’s a quick plug for a great article about the use of the DIA TMF Reference Model by CROs. The Reference Model is a standardized model for the structure and content of the essential documents that comprise the trial master file for all clinical trials that was developed by a working group within the Drug Information Association (DIA). Take-up by the industry has been very rapid but especially so by contract research organizations (CROs) who see the model as a means of reducing differences – and therefore cost – between the filing practices employed for their clients’ documentation.

Click HERE to access the article.

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About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in e-records, Records management practice, TMF. Bookmark the permalink.

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