The IRB policy "Records" has been revised to reflect the following administrative clarifications:
- Additional information added about what is retained in the IRB Administrative Office files for protocols that receive full Board review, expedited review or exempt status);
- How information is currently maintained in the internal IRB Administrative Office clerical database;
- How information related to non-compliance allegations is maintained and;
- Clarification that investigators must maintain copies of all study records.
In addition, there were several non-substantial editorial revisions to the policy text.