Managing Source Documents & Monitor Reviews

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


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Research site users can use SiteVault to store and maintain source documents and make them available to sponsor or CRO monitors for review. The following flowchart illustrates the source document and monitor review workflow:

Source documents process summary

Managing Studies and Users

Note The steps in this section can only be completed by a Regulatory user.

Complete the following steps to manage studies and users:

  1. Create user profiles for any team members who will upload, manage, or require access to source documents in SiteVault. Ensure that you select the correct user type for each team member.
  2. Create a study.

Adding Study Participants

Complete the following steps to add study participants:

  1. Access the study, and expand the Study Participants section.
  2. Select Create.
  3. Enter the ID of the study participant and an optional note in the Create Participant dialog. Select Save to save and return to the study, or select Save + Create to save and add another study participant.
  4. Alternatively, you can add study participants on the Source Upload page by selecting Create Participant in the Participant column.

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 DDMONYYYY 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.

Click here to view a one-page tipsheet on preparing and uploading source files.

Uploading Source Documents

Note For users who have access to multiple vaults, ensure that you are logged in to SiteVault before uploading source documents. The SiteVault logo is displayed in the upper-left corner of SiteVault.

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, it is recommended that you upload the document as a new version of the existing document.

Complete the following steps to upload source documents:

  1. Navigate to Documents > Source Upload.
  2. Select Choose in the Upload Files section to select files to upload, or drag and drop the files into the blue box.
  3. Optionally, select the preview icon to the left of .PDF or image files to view a preview of the file. You also can select the remove icon to remove the file without uploading.
  4. Complete the following for each document (Tip: If applicable, you can use the header cell in each column to populate the same information for each of the files):
    1. Select a document type from the list in the Type column.
    2. Optionally, enter a description of the file in the Description column. Values can be defaulted based on each file’s naming convention.
    3. Select or create a study in the Study column.
    4. Select or create a participant in the Participant column.
    5. Optionally, enter a start and end date for the file. The 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.
    6. Select whether the document is a copy or original source document from the list in the Copy or Original 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).
    7. Select whether the document is redacted in the Has Redactions column.
    8. Select whether the document is protocol deviation (PD)- or adverse event (AE)-related in the PD or AE Related column.
  5. Select Save.

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. Once finalized, only Regulatory users are permitted to edit fields for the document.

Complete the following steps to finalize source documents:

  1. Navigate to Documents > Library, 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 Actions menu, select Finalize Source.
  4. Review the information in the Finalize Source dialog, enter any missing information, then select Start. The document is moved to an In Approval status.
  5. Select Complete in the upper-right corner of the Doc Info page:
    1. For a copy of a source document that has not been redacted, select the Verified as a Certified Copy, Set Status to Current in the Task: Certify Copy dialog, then select Complete. The document is moved to a Current status.
    2. For a copy of a source document that has been redacted, select the Copy Is Suitable for Monitoring, Set Status to Final option in the Task: Verify as a Redacted Copy dialog, then select Complete. The document is moved to a Final status.
    3. For an original source document, the document is automatically moved to a Final status.

Granting Monitor Access

Note The steps in this section can only be completed by a Regulatory user.

Complete the following steps to grant monitor access to a study:

  1. Add your monitor to your site as a user.
  2. Add the monitor to the study under the Monitor & Auditor Assignments section.

Resolving Monitor Review Feedback

Upon completion of review, monitors will assign a Resolve Review Issues task to your site if needed. The assigned site staff will receive an email that notifies them to review the feedback.

Complete the following steps to resolve monitor review feedback:

  1. Open the task by selecting the link in the email. Alternatively, open the All Tasks view in the Home tab or the Open Monitor Feedback view in the Documents > Library tab, and select the document from the list.
  2. Select Accept in the upper-right corner of the Doc Info page.
  3. Select the annotation to view the monitor feedback.
  4. Select Reply to leave a reply note, or select Resolve to resolve the annotation.
  5. Optional: You can tag the monitor in the reply or resolution by entering the at sign (@), entering a few letters of the monitor’s name, then selecting the monitor from the list.
  6. After you have determined how you will resolve the monitor’s feedback, select Complete in the upper-right corner of the Doc Info page.
  7. Select one of the following options in the Address Review Feedback dialog:
    1. Feedback Will Be Resolved Without Updating This Document: Select this option if you want to resolve the feedback without updating the document.
    2. New Document Version Will Be Created: Select this option if you want to update the document with a new version.
  8. The monitor will receive an email that notifies them of your selection.
  9. If you selected Feedback Will Be Resolved Without Updating This Document, then the document is automatically available for the monitor to rereview.
  10. If you selected New Document Version Will Be Created, complete the steps in the Updating Source Documents section.

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 Actions menu), and use the Make a Copy action or upload a new document to create the new version</a>.

Complete the following steps to update a finalized source document:

  1. From the document’s Actions menu, select Create Draft.
  2. Select one of the following options in the Create New Draft dialog:
  3. Copy File From Current Version [Version Number]: Select this option if you want to copy and edit the existing document.
  4. Upload a New File: Select this option if you want to upload a new version of the document.
  5. When you’re ready to resubmit the document for monitor review, finalize the source.

Viewing Source Documents by Participant


Using eSignatures
Managing Regulatory Documents & Monitor Reviews