Tracking and Revising Team Assignment History

A typical clinical trial can span many months to years and often requires changes of study members. Rules and regulations require clinical organizations to keep records of study team assignments and to promote tight access controls so that only people 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. 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 team members who work on the protocol, region, or site. This view also provides details about the role 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 the member's role.
   Start Date	Select the start date and time for the team member. If you add a member 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	Select the end date and time for the team member. If you remove a member from the team of a protocol (either manually or through reverse of Position Rollup mechanism), then the end date is populated with the system date. The system date overrides the date that exists in the End Date field if the record is not read-only.
   Lock Record	Select this field to make the record read-only and to make the End Date field a required field.

   
   

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

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

When you click 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 Team History view for sites and the Team History view for regions as if they are manually added.

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 you remove a member 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 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.