Setup for Monitoring and Management of Source Documents

We recommend that you complete the following steps before creating source documents for monitoring:

• User Accounts: A Site Administrator should create user accounts for any study team members who will upload, manage, or require access to source documents in SiteVault. Ensure that you select the correct system role for each user.
• Study: A Site Administrator should create a study.
• Study Participants: Add study participants to the study.
• Grant Monitor Access: A Site Administrator should create an External User account for the monitor and assign them to a study. This will enable your monitor to log in and view approved documents to complete their review.

Preparing Source Documents for Uploading

1. Scan informed consent forms (ICF) and logs separately from visit-related source documents.
2. You can combine visit-related source documents from multiple visits into a single scan. In such cases, scan in increments of no more than 30 pages to enable more effective monitor review.
3. Organize the scanned documents into participant-specific folders. This enables you to upload all documents for one participant at a time.
4. Optionally, name the scanned files by specifying a date (in YYYYMMDD or DDMMMYYYY format), a double underscore (__), and a description, for example, 20201221__Visits 3-5.pdf. This ensures that the documents are more identifiable when uploaded to SiteVault. The date that you include in the filename is automatically added to the End Date field, and the description is added to the Description field of the uploaded document.