Who can complete this task?
  • Clinical Basics: CTMS Vault Admin, Clinical Basics: Study Manager, Clinical Basics: Monitor

A communication log is a comprehensive record of all interactions between the sponsor and the site that occurred during a study. You may contact the site, for example, to coordinate logistics for an upcoming monitoring visit. And the site may contact you with, for example, questions about the protocol procedures.

It is important to record all emails, phone calls, text messages, etc. to maintain compliance with regulatory requirements and Good Clinical Practice.

There are two ways you can record site communications:

  • Email them to your Vault
  • Record them manually

Email Communications to Your Vault

To email communications to your Vault:

  1. Send an email to: studycommunications@urldomain.veevavault.com, replacing urldomain with the URL domain of your Vault. (Find your URL domain in the URL you used to access Veeva Clinical Basics.)

    Web address bar

  2. Navigate to Study Management > Site Communications and click the ingested email link.

    Clicking email link

  3. Click Edit.

    Clicking edit

  4. Add the communication details and click Save.

    Entering email details and clicking Save

  5. If the ingested email had an attachment, you can find it in the Document Inbox (TMF Workspace > Library > Document Inbox).

    Document inbox

Record Site Communications Manually

To record a site communication manually:

  1. Navigate to Study Management > Site Communications and click Create.

    Clicking Create from Site Communications

  2. Select Site Communication as the Log Type and click Continue.

  3. Complete the details of the communication and click Save.

    Entering communication details and clicking Save