Subject Approvals page

On the Subject Approvals page, you can view, approve, or reject all requests for approvals that have been assigned to your role. These requests can be completed or waiting for review.

Each request includes details of the transaction, such as the change requested, requests for approval that have already been completed for this subject, and requests for this subject that are pending approval.

You must have appropriate permissions to access or act on the requests on this page. You only see the requests that are assigned to your role.

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

Fields on this page

This table describes the default fields for this page. Your study might require different fields, and those fields could have different names.

Field	Description	Notes
Approvals
Show Completed Requests	If selected, a list of requests available to your role and approval status are displayed.
Status	Indicates the level of approval required. First-level approval Second-level approval	READ-ONLY
Subject Number	The unique identifier assigned to the subject, which is typically assigned during the randomization visit.	READ-ONLY
Site	The unique identifier assigned to the site to which the subject is assigned.	READ-ONLY
Site Name
Investigator Last Name	The last name of the Principal Investigator.	READ-ONLY
Transaction Name	A brief description of the transaction for which approval is requested. The request types are: Data Changes: The request is to change visit information, such as subject demographics. Roll-Backs: The information gathered during a visit is restored to a previous visit. Reallocation: The drug units allocated by IRT but not given to the subject are returned to the system so the drug units can be dispensed during another visit. Out of Age Range: A subject does not meet the age requirements of the study. Out of Window: The visit is rescheduled to a date earlier or later than the scheduled date.	READ-ONLY
Request Date	The date the approval was requested, displayed in local time format.	READ-ONLY
Need by Date	The latest date by which you must decide whether to approve or reject the request.	READ-ONLY
Latest Activity	The latest activity on the approval. Requested: The request has been made but not yet reviewed. 1 Level of Approval: The first approver has approved the request. Approved: The request was approved. Rejected: The request was rejected.	READ-ONLY
Details
Other details of the transaction from which the request was made.	The details depend on the type of transaction, but typically include: Brief transaction name. Name of person requesting the approval. Date of the request. Other details of the transaction, such as factors affecting drug units (temperature, status).	READ-ONLY
Comments	Your comments about the request. Example: You reject a request for an out-of-age approval. Your comment says the subject should be screen failed.	REQUIRED. Maximum length: 4000 characters
Approve	Approves the request. The data changes in the subject transaction are saved.
Reject	Rejects the request. The data changes in the subject transaction are discarded.
Other Subject Approvals
Previous approvals for this subject	A summary of previous approval requests, such as: A description of the request The date of the request The status of the request (approved or rejected ). Each item in this list is linked to the original request, unless you do not have permissions to view the request.	READ-ONLY
Pending Approvals for this Subject	A summary of requests in progress, such as: A description of the request. The date of the request. The level of approval ( or ) required for the request. Each item in this list is linked to the original request, unless you do not have permissions to view the request.	READ-ONLY