Update: Minor Revision to Milestones Worksheet

It was recently noted by one of our very observant users that the Milestones worksheet included eight artifacts for which milestones were not suggested! Once we were made aware of this gap, the milestones team very rapidly reviewed these eight artifacts and assigned milestones. The revised worksheet (v1.1) has now been approved by the Steering Committee and is available to download from the Resources page.

Many eTMF systems now included milestone assignments for each artifact so you should find this tool helpful to check your system configuration. In addition, the worksheet can be extremely helpful to assist with manual QC and completeness checks of paper TMFs. We have seen a great example where a sponsor has created trial, country and site level checklists for each milestone, based on the TMF Reference Model worksheet. These provide an invaluable tool to study team members who need to know which documents to check for at each filing level and at each milestone.

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Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry