Documents filed at Study Level or Country Level

[Leah Hiebert]

Hi, everyone – my team is working on adding clarifying details to our Documents Map (based on TMF Ref Model v3) that helps Users understand which documents should be filed at the Study Level vs. at the Country Level. We’d appreciate your feedback and insight on how to make it easier for our Users to determine where to file such documents.

We’ve thought about adding guidance details to the TMF Level column headers on the Map…adding a comment in the applicable cell on an Excel spreadsheet…adding guidance details to an additional ‘company-specific’ column, etc.

[Jaclyn Verrow]

We provide the clarification in the Filing Guidance within our Index to ensure users know which level to file certain documents. For example, Central IRB documents are filed at Country Level, Local IRB documents are filed at Site Level.

[Janna Gonzalez]

Hi Jaclyn,

Where do I file Study level IRB Initial Approval letter?

thank you,
Janna

[Author]

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