To upload documents to active filing levels and milestones, navigate to the study Dashboard. All active filing levels and milestones and their associated artifacts are displayed on this screen.
The Allow upload to inactive milestones setting will allow users to upload documents to inactive milestones. If this is enabled, it will be possible to upload documents to any milestone at any time.
There are three ways to upload documents to required artifacts :
- Main upload button: Click Upload, then choose whether to upload from the device or from the Collaborate file system. Select the document, then choose an artifact to which the document(s) should be associated with; or select Unclassified, allowing the document to be assigned an artifact later:
- To the specific artifact: Under List of Artifacts, when scrolling through the list to select the artifact to upload document(s)to, the system will display an Upload button next to the artifact name. Click the button and upload document(s) from the device or file system directly into that artifact.
- From the Collaborate File System:
- Select one or more documents in a single Collaborate folder
- Choose the Upload to eTMF action in order to upload the latest version of the selected document(s) to eTMF.
- Choose the study, filing level, and artifact.
- Select whether to retain the latest version of the source document in the Collaborate environment or delete it.
Document selections must be made from one Collaborate folder at a time (users cannot upload documents from multiple Collaborate folders to eTMF in one single action).
Track document completeness
As documents are uploaded throughout the study, the document filing completion status is tracked in the Completeness Report section of the Dashboard.
Clicking Export Full Report opens a pop-up with a link to the folder in the Collaborate environment where the report will be saved.
Exported reports are stored in a __Reports__ folder within eTMF, organized into subfolders by user. Access is role-based:
- Power Users with an eTMF role and administrators can view all user subfolders.
- All other users can only access their own subfolder.
Exported report files follow this consistent naming convention: “etmf_completeness_report_<studyCode>_<yy-MM-dd_HH-mm-ss>.csv”
Once the report has been generated, the requesting user will receive an email notification. The email received will depend on the outcome:
- Your eTMF Completeness Report is ready: The requesting user receives this email when the report has been successfully generated and includes a direct link to their user folder under the __Reports__ parent folder in Collaborate.
- Your eTMF Completeness Report could not be generated: The requesting user receives this email when the report failed to generate and includes an error ID for troubleshooting support.
View source information for TMF documents originating in Collaborate
View the source information for documents added to eTMF from Collaborate with the Source file field on Document Details.