1

Configure the approvals for the study

For more information, see the Administration Guide.

Configuration

General Configuration

Transaction Configuration

Oracle and the sponsor work together to identify:

• Each of the transactions that require approvals.
• The approver roles that should be assigned to each transaction.

2

Request the approval for a transaction

Example: The site user corrects an inaccurate birth date.

Subjects

Subject Transactions

When a user makes a change that requires approval, IRT sends:

• An email alert to approvers to let them know they should review the request.
• An email confirmation to the requester as a record of the request.

  A subject affected by a request for approval is locked () until the request is reviewed and either approved or rejected.

3

Review and then approve or reject the request

Approvals

Subject Approval

As an approver, you can check the Subject Approval page for a list of requests assigned to your role. On that page, you can view:

• The status of the request, such as whether other approvers have already approved or rejected the request.
• Details of the request, such as the change requested, dependences, and other change requests for the same subject.