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The process of correcting subject information
The information you collect about a subject must be accurate. If an error does occur, you can correct it by following the processes your sponsor has set up in IRT.
You can correct subject information through these methods:
- Edit the subject visit data to correct subject information that was entered incorrectly.
- Flagging a subject who no longer meets study requirements.
- Re-allocate incorrect drug units that were given to the subject but were not identified by IRT.
- Roll back an entire visit to a visit's previous state to delete a transaction against the wrong subject or re-do a visit with incorrect information that might affect outcome.
These changes might need to be approved through the approval system built into IRT. The sponsor decides on the manner this system is set up at your site, such as the fields that can be edited and which transactions require approvals.
The subject's record is locked (
) until the approver makes a decision, and you cannot give the drug units to the subject until approval is received.
IRT records all edits to subject information in the audit log, and these changes are included in the final report for the study.
