Milestones / Events Published for TMF Reference Model Artifacts

We are pleased to announce the publication of the final deliverables from the Milestones Sub-group, led by Kathleen Kirby.

The purpose of this document is to define the latest point in time when an artifact is to be submitted / filed within the TMF. Of course, there is a regulatory expectation that artifacts are filed contemporaneously so our guide simply identifies the latest filing time that we think is reasonable. In addition, as this is a guide, each Sponsor should modify the Milestone/Event list according to their practices. The intention of Milestones/Events is to ensure maintenance of the TMF on an ongoing basis.

Many artifacts will require updating throughout the trial. We have assigned the first Milestone/Event where the artifact would typically first appear in the TMF. At the time Milestones/Events were incorporated into the TMF Reference Model, only one Milestone/Event was assigned to each artifact for each level. Future plans include adding in additional Milestones/Events at each level.

It should be noted that if the Sponsor wants FEWER Study Milestones / Events to track to (for example, to align with a Clinical Trial Management System), they can roll up into a later Study Milestone / Event as these are listed broadly in chronological sequence. Conversely, if the Sponsors wants MORE Study Milestones / Events to track to, they can create their own OR utilize the sub activities identified.

If artifacts are filed and then updated, the updated artifacts are to be filed contemporaneously with collection (in real time).

For further information, including a short list of Frequently Asked Questions and a copy of the TMF Reference Model that includes the milestones and events (see Excel columns U-Z), please refer to the Resources web page.

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Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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