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

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 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.

To manually create protocol assignment team history

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

   Field	Comments
   Role	Select the value that best describes each individual's role.
   Start Date	If a team member is added from the Team of a Protocol (either manually or by using the Position Rollup mechanism), the start date defaults to the system date, and the end date is blank.
   End Date	If a team member is removed from the Team of a Protocol (either manually or through reverse of Position Rollup mechanism), 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.