CTMS and eTMF Integration Process Flow

The overall process flow involved in the integration between CTMS and eTMF is as follows:

1. After a site visit is approved, a trip report file is automatically generated with a status of Approved.

   For this initial step to happen, integration must be enabled between CTMS and eTMF as shown in Enabling Integration Between CTMS and eTMF.

   If for some reason, a trip report file is not generated automatically once a site visit is approved, then an email is sent to the concerned CRA notifying them of the situation. In this instance, the CRA must contact their administrator to see if this is due to a network or other issue and once confirmed, the CRA can manually generate the trip report file by clicking Generate Report. For more information, see Manually Generating Trip Report Files.

2. The approved trip report file is automatically added to the Site Visit Attachment view and an email is sent to the key CRA and eTMF recipients notifying them that an approved trip report file is ready to be sent to eTMF.

   You set up the email recipients as shown in Configuring Email Recipients.

3. The approved trip report file is then pulled from CTMS into eTMF using the LS Clinical Trip Report File Transfer Web service.

   For information on setting up this Web service, see Configuring the LS Clinical Trip Report File Transfer Web Service.

4. eTMF uses the same LS Clinical Trip Report File Transfer Web service to return the following information to CTMS:

   • Received date. The date the trip report file was received by eTMF.

   • URL link. The URL link to the trip report file in eTMF.

   CTMS stores this returned information in the Site Visit Attachment view of that trip report.

   New versions of a trip report, once approved, are sent to eTMF in the same way.