The TMF Auditor role is a purpose built user type for limited access to the eTMF and reports areas. The role is designed for the responsibilities of an eTMF auditor.... allowing review of files and metadata posted to the TMF, as well as as the audit trail for TMF changes.
The TMF Auditor has access to:
- Only the specific studies that are authorized, unless the user is setup to automatically assign all studies.
- The Documents / eTMF as a view-only user
- This includes all folders and documents, unless some folders have limited permissions based on the "Folder Permissions" feature.
- This includes Document Details and file Preview, but no Download capability.
- The 04. Documents / eTMF reports category in the CTMS / eTMF Reports view.
- This reports category includes a document listing, folder listing and document history (i.e. audit trail).
Since the TMF Auditor does not have download capability for files posted to the TMF, please note that some file types may not be reviewable by the auditor user. Here are some examples:
- PDF files are generally available for Preview
- Office files (e.g. Word, Excel, Powerpoint) can typically be available for Preview via a generated PDF preview
- Office files which are password protected are encrypted and will not be available for preview
- Text files and image files can typically be available for Preview via a generated PDF preview
- Other files type, such as zip files, video, audio, etc. are not available for preview
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