Managing Regulatory Documents & Monitor Reviews


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Managing Studies and Users

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

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.
  3. To the study, assign the study team, partners, and products.

Uploading Regulatory Documents

See Managing Documents for more information.

Approving Regulatory Documents

Depending on the document type, initiate the approval workflow by using one of the methods here.


Managing Source Documents & Monitor Reviews
Training Workflows