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People involved in subject approvals
The approval process involves these people:
- Requester
The requester is a site user who asks for approval for a change to subject information during a transaction. Some of these requests might occur automatically based on selections made during a visit (example: a request for an out-of-age subject to enroll in the study might be made automatically based on the subject's date of birth). However, a requester makes most requests deliberately (example: a visit rollover to change the subject's status when the subject is screen failed in error).
- Approver
The approver is assigned the IRT role that approves or rejects requests to change subject information. Different roles can be assigned to different types of approval requests. A role is assigned the responsibility to approve these requests through the Configuration menu.
A change to subject information might require no approval, one level of approval, or two levels of approval. For more information, see Levels of approval.
- Subject
A subject is a participant enrolled in the study who, after screening, is provided drug units identified by IRT. A site user might need to correct information that was logged for the subject during a visit, and therefore requests approval for this change. If a change to subject information requires approval, the subject is locked (
) until the request is reviewed.
