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

• CTMS and eTMF Integration Process Flow

• Process of Setting Up Integration Between CTMS and eTMF

• Enabling Integration Between CTMS and eTMF

• Configuring Email Recipients

• Configuring the LS Clinical Trip Report File Transfer Web Service

• Manually Generating Trip Report Files

Note: The feature described in this chapter is available in Siebel CRM 18.9 Update and later releases.

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:

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.

Process of Setting Up Integration Between CTMS and eTMF

To set up integration between CTMS and eTMF, perform the following tasks:

1. 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.

2. Configuring Email Recipients

3. Configuring the LS Clinical Trip Report File Transfer Web Service

4. (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.

Note: Siebel Clinical must be integrated with Oracle Business Intelligence Publisher (BI Publisher) to generate reports.

To enable CTMS integration with eTMF

1. Navigate to the Administration - Application screen, then the System Preferences view.

2. Set CL - Generate TripReport to Y to enable trip report generation after approval.

3. (Optional) The following business component calculated fields can be configured:

   BC Name	Field	Field
   Clinical Trip Report	TR File Name	TR File Type

   The default file naming convention for the trip report file is as follows:

   • TR File Name: Trip Report_<Id>_<site visit date>_<account>

   • TR File Type: PDF

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

1. Navigate to the Administration - Application screen, then the System Preferences view.

2. Configure the system preferences as shown in the following table.

   System Preference Name	Value	Description
   CL - TripReport Email Template	Trip Report Email Template	The trip report email template to use to send an email to the recipients defined in the CL - TripReport Email To List system preference (notifying them that an approved trip report file is ready to send to eTMF). The Trip Report Email Template is available and configured by default and, if required, customers can modify the template.
   CL - TripReport Email Profile	<Trip Report Email Profile>	The trip report email profile to use. The following step shows how to define the email profile.
   CL - TripReport Email To List	<Recipient List>	A semicolon-delimited list of email addresses to which an email is sent after Trip Report generation.

3. Define an email profile as follows:

   1. Navigate to the Administration Communication screen, then the Communication Drivers and Profile view.

   2. Query for Internet SMTP/POP3 Server and then create a new record, name it Trip Report Email Profile and set the parameters for the email profile as shown in the following table.

   Parameter Name	Value
   From Address	[e-mail]
   SMTP Server	<SMTP Server VM>
   SMTP Server Port	<SMTP Server Port>

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

1. Navigate to the Administration — Web Services screen, then the Inbound Web Services view.

2. Query for and select the LS Clinical Trip Report File Transfer Web service.

3. Configure one or more of the following input parameters in the LS Clinical Trip Report File Transfer Web service to pull a specific trip report or a group of trip reports from CTMS into the eTMF system.

   Note: The input parameters that you configure will act like a filter. Only trip reports that match all the criteria (configured input parameters) will be pulled. For example, if the Protocol parameter and no other parameter is set, then all trip reports for the specified protocol will be pulled.

   Field	Description
   Trip Report ID	The ID associated with the trip report.
   Visit Name	The name of the site visit.
   Visit Type	The type of site visit.
   Visit Start	Starting date of the site visit.
   Protocol	The protocol or study ID.
   Site	The site associated with the trip report file.
   Region	The geographical region to which the site belongs.
   Principal Investigator	The principal investigator for the site (contact associated with the site).
   Approved Date	The date the trip report was approved.

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.

To manually generate a trip report file

1. Navigate to the Site Visits screen, then the Clinical Site Visits List view.

2. Query for the approved site visit that you want (where the trip report file failed to generate).

3. Click Generate Report.

   A trip report file is generated with a status of Approved and it is automatically added to the Site Visit Attachment view