Summary

This article covers the steps necessary in order to create an EDC site from a CTMS site.

Table of Contents

Once a study has been linked to a study in Trial Manger, either through the creation of or manual linking, a site can be created in the Trial Manager based on the information from the CTMS. Users must have the permission to add sites in Trial Manager to be able to create and link sites in CTMS.

To create or link to a site in Trial Manager, a user must be either:

  • An unrestricted user with read/write permission to create/link study sites or;
  • A restricted user with read/write permission to create/link study sites

User type and permissions sets are managed by each CTMS environment’s CTMS Administrator.

Note: A linked site will display patients for the site only, children site patients will not appear in CTMS.


 

Create a Site in Trial Manager

  1. Select “Create Site in Trial Manager”, on the Study Site Form the Actions menu.
  2. The Create Site in Trial Manager Confirmation screen appears with a dropdown that contains the existing sites in Trial Manager.
  3. Select the parent site for the site in Trial Manager.
  4. Select Confirm.

 

Linking EDC Site from CTMS Site

When an existing Trial Manager site needs to be linked to a site, the Linking EDC Site utility can be run to link the EDC and CTMS sites. When a site is linked the Study Site Name in the CTMS will update the Trial Manager Site Name if the names are different.

  1. Select “Link to EDC Trial”, on the study site form from the Actions menu.
  2. The Link to EDC Site screen will appear with a dropdown of all sites in the study Trial Manager that has not been linked to a site.
  3. Select the site to link to in Trial Manager.
  4. Select Link.

Unlinking EDC Site from CTMS Site

When a CTMS site has been linked in error to a Trial Manager site, the site can be unlinked by running the Unlinking utility.

Note: When unlinking a site, all patients (and their data) are deleted, including manually entered data.


To unlink a Site:


  1. Go to the Study Site Form.
  2. Select “Remove Link to EDC Site” from the actions menu.
  3. A screen will appear, prompting you to confirm.
  4. Select Confirm to confirm unlinking.

 

Trial Manager Site Linked Data

When a site is created in Trial Manager (or a link to a site occurs) the following fields for the site in Trial Manager are populated with the data from CTMS Study Site Form:

  • Street Address Line 1
  • Street Address Line 2
  • Suite/Office/Floor
  • City
  • State/Province
  • Postal Code
  • Country
  • Phone Number
  • Fax Number

When the CTMS Site Form is updated the data is automatically updated in Trial Manager.

 

Go to EDC

When a site has been linked to a site in Trial Manager, the Actions menu at the Study Site form level will contain a “Go to EDC” action, which takes the user to the EDC site.

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