Make sure everything you enter is accurate.

You are responsible for making sure all subject information logged during a visit is accurate.

This information includes:

• Subject demographic information. Always verify this information against the source record when you enter the subject information.
• Additional study-specific data required by the protocol (example: disease scores such as PASI scores or Mayo scores).

  Although you can edit subject information after saving it, changes to subject information might require approval. While you are waiting on a decision, the subject is locked in IRT. As a result, you cannot log visits or dispense drugs to the subject.

  So, be sure to double check the data before you click Continue or Submit to save information during a subject transaction.

Verify the subject's identity against the demographics in IRT.

When you meet with the subject for the initial screening visit, you log important demographics that help you to identify the subject in all other visits in the visit schedule.

The information you log varies with the set-up of the study and the regulations of your geographic area, but might include details such as birth date, gender, initials, and transaction date.

Give the subject the specific drug units identified by IRT.

Check the drug units you take from inventory against the transaction record to make sure you are dispensing exactly those drug units.

The main function of IRT is to keep track of the drug units ordered and provided to subjects at a site.

It is critical for subject safety that you give the subject the exact drug units identified by IRT.

Since IRT manages drug inventory based on site transactions, the drugs you dispense also affect how efficiently IRT operates.

Be aware that some transactions require approval.

Certain transactions, such as corrections to subject information, might need to be approved. Check with the field monitor for details on the approval process for your site.

If you request a change to subject information that requires approval, the subject is likely to be locked until a decision is made. If that happens, you cannot log additional subject information or give drugs to the subject.

Be sure to leave sufficient time before the next visit so the approver has time to respond to a request for approval.

You are notified of every transaction, so expect to receive email from IRT.

After each transaction, IRT sends you an email notification as a record of the event.

You receive emails in situations like these:

• After each visit.
• After special transactions, such as screen failures, early termination, or transfers to another site.
• When you correct subject information.
• When you request approval for a change to subject information.
• When a request is approved or rejected.