Subject Visit Details page
From this page, you can correct an error in the subject information that is entered during a visit.
Changes to subject information could require approval. If the field is marked with an asterisk (*), changes to the field must be approved. A subject affected by a request for approval is locked (
) until the request is reviewed and either approved or rejected.
Note: You cannot edit subject data through the phone interface.
Fields in the Edit Subject Data section
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
|
Edit Subject Data
|
Field Description
|
The name of the field that was corrected.
If the field is marked with an asterisk (*), the field requires approval for editing. A subject affected by a request for approval is locked () until the request is reviewed and either approved or rejected.
|
READ-ONLY
|
Dependencies
|
Other transactions that are affected by the transaction where the data was corrected.
This field is informational only.
|
READ-ONLY
|
Current Value
|
The value of the field that was logged during the visit.
|
READ-ONLY
|
New Value
|
The corrected values of the fields.
|
|
Reason for Change
|
The reason for changing the data. Provide a reason for each field in the New Value column.
|
REQUIRED.
Maximum length: 4000 characters
|
Fields in the Drug Reallocation section
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
|
Reallocate
|
When selected, identifies the drug unit to reallocate.
|
|
Trial Supply Allocated
|
The unique identifier or lot/expiration date for the drug units allocated to the subject by IRT.
|
READ-ONLY
|
Trial Supply Dispensed
|
The identifier or lot/expiration date of the drug unit that was provided to the subject during the visit.
|
|
Is the Allocated Trial Supply still at the site?
|
The drug unit is at the site (Yes) or not at the site (No).
|
|
Reason for Reallocation
|
The reason the drug units must be reallocated.
Include the current location of the allocated drug units, if you know the location.
|
Maximum characters: 255
|
Fields in the Additional Request Data section
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
|
Comments to Approver
|
Detail about the request.
|
REQUIRED. (for rollback)
Maximum characters: 4000
|
Need by Date
|
The date by which the request must be approved.
|
REQUIRED. (for rollback)
|
Rollback Visit
|
Rolls back the visit data to a previous version of the visit.
|
|
Submit
|
Confirms each step of the visit as you verify details or provide the appropriate information.
|
|
