Summary

This article covers the necessary actions required to use CTMS and EDC together by linking a trial manager study to a CTMS study.

Table of Contents

When using CTMS and EDC for the same study, the Trial Manager and CTMS must be linked for the data to populate from the EDC into CTMS. When starting a new study, the Trial Manager study and site can be created from within CTMS. For studies and site that exist already in the Trial Manager, the study and site can be manually linked from within CTMS.

Users must have the Configurator role for Trial Manager to be able to create and link studies or to link sites. Users must have the permission to add sites in Trial Manager to be able to create sites.

Creating Trial Manager from CTMS

Once a study is added to the CTMS Study Manager, the study information can be populated in Trial Manager for EDC trial design to begin.

Note: A study can only be created in Trial Manager on the production server, on approve servers an existing study (from production) must be linked.


Create a study in Trial Manger

  1. In CTMS access the Study Form for the created study.
  2. Select Create Study in Trial Manager in the Actions menu.
  3. The Create Study in Trial Manager Confirmation will appear.
  4. If Trial Manager sub-clients appear, the Trial Manager dropdown will contain the name of each sub-client. Select the location the study shall appear in the Trial Manager and select confirm.
  5. The user will be directed to the Trial Manager Setup form for the study created.
Note: The Role Set in Trial Manager is created with all roles defined on the Edit Study form.


Linking Trial Manager Study to CTMS Study

When an existing Trial Manager trial should be linked to a CTMS study, the Linking Trial Manager Study utility can be utilized.

Note: A user must have access to the study on the approve servers to link to the study.


  1. In CTMS access the Study Form for the created study.
  2. Select Link to Trial Manager from the Actions menu.
  3. The Link to Trial Manager screen will appear with all Trial Manager studies that do not have a link to a CTMS study.
  4. Select the study to link and select Link.
  5. The user will be directed to the Trial Manager Setup form the linked study.
Note: Once a study that is in progress has been linked the sites must be linked, as patient records cannot be manually added when a study is linked.


Trial Manager Study Linked Data

When a trial is created in Trial Manager or linked, the following fields in Trial Manager are populated with the data from the CTMS Study Form:

  • Protocol
  • CTMS Protocol
  • Product Type
  • Product Name
  • Phase
  • Therapeutic Area
  • Indications to be Studied

Updates to the CTMS Edit Form automatically update in Trial Manager as well.

Go to Trial Manager

When a trial has been linked with a Trial Manager, the Actions Menu on the Edit Study form will contain the Go to Trial Manager option for direct access to the connected trial manager record for the study.

Unlinking Trial Manager Study to CTMS Study

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

Note: When unlinking a study, all patients for all sites are deleted, including manually entered data.


  1. Go to the Study Form for the created study.
  2. Select “Unlink Study in Trial Manager” from the Actions menu.
  3. A screen will appear confirming the unlinking action.
  4. Select Confirm to confirm unlinking.


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