Overview of Integration Between CTMS and eTMF

An electronic trial master file (eTMF) is a content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for clinical trials that may be required for compliance with government regulatory agencies.

CRAs typically create 2-3 trip reports per week, per customer. After site visit approval, any approved trip reports are then moved from CTMS to an eTMF system. With the introduction of this new feature (CTMS integration with eTMF), the approved trip reports can automatically be sent from CTMS to eTMF. This avoids the inefficiency of having to manually move the trip reports.

To facilitate the automatic movement of approved trip report files from CTMS to an eTMF system, CTMS provides the LS Clinical Trip Report File Transfer Web service (an inbound SOAP Web service), which is used as follows:

• The eTMF system calls the LS Clinical Trip Report File Transfer Web service to pull the trip report file into the eTMF system.

  The eTMF system can pull one or more trip report files from CTMS and can schedule this to happen periodically. You can configure any combination of the following parameters to pull trip report files: Trip report ID, Visit Name, Visit Type, Visit Start, Protocol, Site, Region, Principal Investigator, Approved Date.

• The eTMF system uses the same LS Clinical Trip Report File Transfer Web service to send or return the trip report file received date and URL link (to where the trip report file is stored) from eTMF back to CTMS.

• CTMS uses the trip report file URL link to open and review the trip report file as required.