Data Edits

Allow Data Edits
(selections on the left))

The information from a subject transaction can (Yes) or cannot (No) be edited for this study.

Allow Data Edits
(column heading on the right)

The types of subject transactions that can be edited.

Select each transaction that you want users to be able to edit, and deselect those that should not be editable.

Select the transaction type to open the Transaction Configurations page, where you can set up the permissions for each transaction.

Data Reallocation

Allow Data Reallocation

Identifies whether drugs can be reallocated in this study.

• Yes–Drugs can be reallocated when editing subject transactions.
• No–Drugs cannot be reallocated when editing subject transactions. All other options for drug reallocation are disabled.

Acknowledge

The level of acknowledgment required for drug reallocation:

• All Reallocation Transactions–All transactions require acknowledgment.
• No Reallocation Transactions–Drug reallocations can be edited without acknowledgment.
• Incorrect Trial Supply Transaction (Used for Open Label Trials only)–The drug type of the drug units identified by IRT is different from the drug type of the drug units provided to the subject.

Acknowledger(s)

A list of the unblinded roles that can acknowledge a drug reallocation. All active roles from the Manage Permissions page are listed.

Important: The role(s) you select to acknowledge a drug reallocation must be unblinded.

Default role: UNBLINDED Clinical Supplies Manager (or equivalent role for the study)

Alerts Frequency

Approvals Alerts Frequency

When an approval or acknowledgment is requested, IRT sends the first alert immediately. This option sets the number of days between later reminders.

This setting is not for specific alerts. All alerts are sent at this frequency.

Must be an integer.

Range: 0 -99.