Transaction

Transaction

The type of transaction.

When you select the transaction, the configuration settings for that type of transaction appear.

Roll-back settings

Allow Roll-back

When selected, rollbacks can be performed for this study.

You cannot roll back a screening visit.

Re-use Randomization number

When this field is selected, the randomization number assigned during the visit can be reassigned. As a result, gaps in randomization numbers are reduced.

This field appears only if the study is configured for forced randomization.

Roll-back drug status

Indicates the status of the drug was not affected during the visit.

This option is available for these transactions: randomization, scheduled visit, drug replacement, and dose change.

Roll-Back First Approver(s)

A list of the roles that can approve a rollback. All active roles from the Manage Permissions page are listed.

The first-level role approves the request first. After this role acts on the request, the second-level approver is notified. For more information, see Levels of approval in the User Guide.

You can select multiple roles for each transaction.

Roll-Back Second Approver(s)

A list of the roles that can approve a rollback. All active roles from the Manage Permissions page are listed.

This approver has the final say on requests approved by the first-level approver. For more information, see Levels of approval in the User Guide.

You can select multiple roles for each transaction.

Data Edit Settings

Field Description

A list of all fields that editable for this transaction.

READ-ONLY

Allow Edit

When this checkbox is selected, this field is editable in this study.

Approval Required

The level of approval required.

Default: Level 1

Dependencies

The number of functions that are dependent on this field.

The number is linked to a window that shows a list of transactions. You can select a transaction as a dependency if the data affects a result in that transaction.

Example: The field is a weight field that determines dose or strata, which affects the randomization visit. You select Randomization as a dependency.

Example: Gender could affect randomization if males are given one dose and females another.

Default: 0

Data Edit First Approver(s)

A list of the roles that can approve an edit to subject information. All active roles from the Manage Permissions page are listed.

The first-level role approves the request first. After this role acts on the request, the second-level approver is notified. For more information, see Levels of approval in the User Guide.

You can select multiple roles for each transaction.

Data Edit Second Approver(s)

A list of the roles that can approve an edit to subject information. All active roles from the Manage Permissions page are listed.

This approver has the final say on requests approved by the first-level approver. For more information, see Levels of approval in the User Guide.

You can select multiple roles for each transaction.

Submit

Saves the transaction and sends the message to the appropriate function in IRT.