Important! If you have access to multiple vaults, ensure that you are logged in to Veeva SiteVault before uploading source documents. The SiteVault logo is displayed in the upper-left corner. Moreover, ensure that the correct site is selected in the vault selector.
Note If you attempt to create a new Adverse Event Log, IP Accountability Log, or Protocol Deviations Log document for a study participant and an existing document already exists for that study participant, SiteVault displays an error message. Instead of creating a new document, we recommend that you upload the document as a new version instead.
- Navigate to Documents > Study eBinder.
- Expand the Upload dropdown menu to select Bulk Upload Source Docs.
- Select one of the following upload methods:
- Browse your local folders.
- Select the documents to upload.
- Select Open.
- Drag and Drop
- With the Bulk Source Upload window open, select the documents to upload.
- Use your cursor to drag the documents from the local folder into the Bulk Source Upload dialog.
- Browse your local folders.
- Complete the required and any additional optional fields as needed. Note: You can apply the same content to all fields in a column by populating the header row field. Individual fields can be adjusted at the row level, as needed.
- Select Save to complete the process.
If you need to edit a field on a document after saving, open the document and select Edit Fields (
) in the Document Information panel. Once finalized, only Site Administrator users can edit the fields on source documents.
When you’re finished creating source documents, ensure that you finalize all documents to make them ready for monitor review.
Source Upload Tips
See the following tips and tricks for using the Upload Source Documents wizard in the Study eBinder:
- Documents with a hyperlinked filename (formatted as an image or PDF) will generate a preview when clicked.
- Use the header cell of a column to enter the same information for every file.
- The Upload As column allows you to upload files directly to the steady state.
- If needed, you can create a new participant for a file during the upload process. Select the Participant field on the row of the file and select +Create.
- The start and end dates should reflect when the data was captured. Values can be defaulted based on each file’s naming convention. If a date was included in the document’s filename, the date is automatically added to the End Date field of the uploaded document.
- Copy Certification Verdict: A document is considered a copy of source if it has been downloaded from an electronic source or electronic health record (EHR) system or if it has been scanned before being uploaded to SiteVault. A document is considered an original source document if this is the file where the data was originally captured (for example, if a .DOCX file was completed during the visit). SiteVault’s Copy Certification process should be completed on documents considered a copy of a source.
- Hover over a row and select the remove icon (
) to remove the file without uploading.
SiteVault
