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Subject data edits
If information about the subject is entered incorrectly during a visit, you might be able to change that information. However, you can only change data in individual fields the sponsor has identified as editable.
Edits to subject data might require approval. 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.
When editing subject information, you do the following:
- Verify the subjects' identity against the basic demographic information gathered during screening.
- Correct the inaccurate information.
- Provide a reason for the change.
- If approval is needed, provide the date by which you need the approval (for example, the day before the subject's next visit).
When you complete the edit, IRT sends you an email confirmation as a record of the information you changed.
