Managing Source Documents for Monitoring

Follow the step-by-step instructions below to learn how to create source documents and make them available for monitoring.

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Overview

Note Sites should decide based on their internal processes and agreements with sponsors or contract research organizations (CROs) what type of source documents and information to store and share in SiteVault. Click here to download the monitoring resource kit.

You can use SiteVault to store and maintain source documents and make them available to sponsor or CRO monitors for review. Source documents in SiteVault follow the Draft to Current - Source and Draft to Final - Source lifecycles.

See below for how to create and manage source documents. See the Managing Monitoring Reviews page for information on how to resolve monitor review feedback, and see the Basics of Managing Documents page for general information on working with documents in SiteVault.

The following flowchart illustrates the source document and monitor review workflow:

Setup for Monitoring and Management of Source Documents

We recommended that you meet the following prerequisites before you begin creating source documents for monitoring:

• User Profiles: If not already created, a Site Administrator user should create user profiles 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: If not already created, a Site Administrator user should create a study.
• Study Participants: Add study participants to the study.
• Grant Monitor Access: If not already granted, a Site Administrator user should create an External User profile 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

Complete the following steps to prepare 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.

Uploading Source Documents

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.

Complete the following steps to upload source documents:

1. Navigate to the Documents > eBinder tab.
2. Expand the Upload dropdown menu to select Bulk Upload Source Docs.
3. Select one of the upload methods below:
   • Browse your local folders.
     • Select the locally saved documents.
     • Select Open.
   • Drag and Drop
     • With the Bulk Source Upload dialog open, select the locally saved documents on your computer.
     • Use your cursor to drag the documents from the local folder into the Bulk Source Upload dialog.
4. 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.
5. 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 Source Upload tab to upload source documents:

• Select the hyperlinked filename to preview the file.
• 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 filename of the document, the date is automatically added to the End Date field of the uploaded document.
• For the Copy Certification Verdict column, 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).
• Hover over a row and select the remove icon () to remove the file without uploading.

Finalizing Source Documents

Finalizing a source file that has been uploaded to SiteVault signifies that the file is an official record in your investigator site file.

Complete the following steps to finalize source documents:

1. From the Document Library or Study eBinder, open the document that you want to finalize and review the information on the Doc Info page for accuracy.
2. If applicable, select Edit Fields to update information as needed.
3. From the All Actions menu, select Change Status to XXXX where “XXXX” is the document type’s final status.
4. Complete the Document Date field.
5. Additional Actions
   • If no further actions are required, select Save to complete the process.
   • If copy certification is required, select Perform Copy Certification.
   • Complete the copy certification.
   • Select Save to complete the process.

Updating Source Documents

Tip When creating a new draft version for corrected source documents, you can upload only the page(s) that require correction. Use the version comments and description to indicate the reason for the partial upload.

Note If you need to update a source document that was created before January 1, 2021, the Create Draft action is no longer available. Instead, update the document to a Superseded status (select Change State to Superseded from the Workflow Actions menu), and use the Make a Copy action or upload a new document to create the new version.

Complete the steps in the Creating New Draft Versions section of the Basics of Managing Documents page to update a finalized source document. Ensure that you finalize the document to make it ready for monitor review.

Viewing Source Documents by Participant

To view the source documents for a particular participant, navigate to the document library and use the filters to filter the library by the study and participant.

Resolving Monitor Annotations

See the Managing Monitoring Reviews page to learn how to resolve monitor review feedback.

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Basics of Managing Documents

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Related Help

• Managing Monitoring Reviews
• Monitor & External User Access