15Setting Up Integration Between CTMS and eTMF
Setting Up Integration Between CTMS and eTMF
This chapter describes how to integrate CTMS with an electronic trial master file (eTMF) system. It includes the following topics:
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.
CTMS and eTMF Integration Process Flow
The overall process flow involved in the integration between CTMS and eTMS is as follows:
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.
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.
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.
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.
Process of Setting Up Integration Between CTMS and eTMF
To set up integration between CTMS and eTMF, perform the following tasks:
Enabling Integration Between CTMS and eTMF
Integrating Siebel Clinical with Oracle Business Intelligence Publisher (BI Publisher) to generate reports is a prerequisite to this step.
Configuring the LS Clinical Trip Report File Transfer Web Service
(Optional) Manually Generating Trip Report Files
Enabling Integration Between CTMS and eTMF
CTMS integration with eTMF is disabled by default in Siebel Clinical. The following procedure shows how to enable CTMS integration with eTMF so that trip report files, upon site visit approval, will automatically be sent from CTMS to eTMF.
This task is a step in Process of Setting Up Integration Between CTMS and eTMF.
To enable CTMS integration with eTMF
Configuring Email Recipients
When an approved trip report file is automatically added to the Site Visit Attachment view, an email is sent to key CRA and eTMF recipients notifying them that an approved trip report file is ready to send to the eTMF system. The following procedure shows you how to configure the email recipients.
This task is a step in Process of Setting Up Integration Between CTMS and eTMF.
To configure email recipients
Configuring the LS Clinical Trip Report File Transfer Web Service
The eTMF system calls the LS Clinical Trip Report File Transfer Web service (an inbound SOAP Web service provided by CTMS) to pull the trip report file into the system and in turn send the trip report received date and URL link from eTMF back to CTMS.
To pull a specific trip report or a group of trip reports from CTMS into the eTMF system, then configure one or more of the input parameters, as listed in the following procedure, in the LS Clinical Trip Report File Transfer Web service.
This task is a step in Process of Setting Up Integration Between CTMS and eTMF.
To configure the LS Clinical Trip Report File Transfer Web service
Manually Generating Trip Report Files
If for some reason a trip report file is not generated automatically once a site visit is approved (this is usually due to BI Publisher not working), then a notification is sent to the concerned team members notifying them of the situation and the Generate Report button on the Site Visits screen is activated.
You configure the team members to notify (upon failure to generate a trip report file once a site visit is approved) in the BC user property BIP Error Notification List. The values you can assign to BIP Error Notification List are Approver, Reviewer, Primary, and Team. The default value is Primary and a maximum of two values can be configured. For example: Approver, Reviewer.
This task is a step in Process of Setting Up Integration Between CTMS and eTMF.