We can get ourselves into trouble when we treat the management of the TMF as a separate and distinct activity from managing the trial itself. We often wind up with two sets of books—the Compliance TMF and the Real TMF.
We can get ourselves into trouble when we treat the management of the TMF as a separate and distinct activity from managing the trial itself. We often wind up with two sets of books—the Compliance TMF and the Real TMF—and spend more time trying to reconcile the two than we would in getting it right the first time. The key is to leverage technology to more fully integrate document generation, information sharing, and record keeping.
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