Siebel Clinical Trial Management System Guide > Setting Up Clinical Trials >

Tracking and Revising Team Assignment History

A typical clinical trial can span many months to years and often requires changes of study members. Clinical organizations are required by rules and regulation to keep records of study team assignments, and to promote tight access controls so that only those who are assigned roles and responsibilities for a trial have the proper access to trial data.

When a person is no longer part of the clinical trial team, all access rights to the trial data cease as well. When necessary, the study manager can also manually create a tracking record independent of the team assignment. Similar functionality applies to region team and site team assignment. The Team History view allows you to administer and track who has worked on the protocol, region, or site. It also provides details about what the role was as well as the start and end dates.

This task is a step in Process of Managing Clinical Trials.

To revise team assignment history

1. Navigate to the Administration - Clinical screen, then the Protocol List view.
2. In the Protocol list, drill down on the protocol number field of the protocol for which you want to create a new team assignment history.
3. Navigate to the Team History view.
4. In the History list, create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Role	Select the value that best describes each individual's role.
   Start Date	If a member is added from the team of a protocol (either manually or by using the Position Rollup mechanism), then the start date is populated with the system date, and the end date is blank.
   End Date	If a member is removed from the team of a protocol (either manually or through reverse of Position Rollup mechanism), then the end date of the team member's record is auto-populated with the system date. The system date overrides whatever date exists in the End Date field if the record is not set to read-only.
   Lock Record	When checked, the record becomes read-only, and the End Date field becomes a required field.

About Automatically Assigning Team Members to a Protocol Using the Position Rolldown Button

When a team member is added to a protocol, click the Position Rolldown button to allow the member to be added to all regions and all sites under the protocol. You can add a member to the team only once.

When you use the Position Rolldown button to add a member to the team of a protocol, a record is created, where applicable, in each of the Team History views for all regions and all sites belonging to the protocol. The Position Rolldown mechanism automates the addition of team members to the Site Team History and Region Team History views as if they had been assigned manually.

About Removing Team Members From the Team of a Protocol

When you remove a team member from the protocol, the team member is removed from either the protocol, or from all protocols, regions and sites belonging to the protocol.

When a member is removed from the team of a protocol (either manually or through Position Rollup or Position Rolldown), the End Date field of the team member's record, if present, is updated with the system date. However, if the record is already read-only, then the initial value in the End Date field is not updated. The Position Rolldown mechanism automates the update of the End Date field of the assignment records as if they are manually removed from the team of the sites and regions.

NOTE:  A prompt appears asking whether to remove the member from only the protocol or from all protocols, regions, and sites belonging to the protocol.