The Clinical Research SOP Collaboration Group (CRCG) has recently updated several SOPs to enhance clarity and support compliance across the research enterprise.
- UUSOP-02: FDA has been updated to clarify appropriate methods for providing study record copies to FDA inspectors.
- UUSOP-06 Supplement A now specifies that Biomedical Engineering is responsible for maintaining calibration records for applicable equipment.
- UUSOP-13: Fee Schedule and UUSOP-13A Supplement have been updated to reflect fees for the upcoming fiscal year.
💡 Helpful SOP Reminders:
Looking for guidance on common research compliance activities? These SOPs provide valuable resources:
- UUSOP-05: Delegation of Authority outlines who should be included on the Delegation of Authority (DOA) Log and provides instructions for completing it correctly.
- UUSOP-06: Study Records Management describes expectations for organizing and maintaining study records and can help teams prepare for monitoring visits.
- UUSOP-08: Obtaining Written Informed Consent provides guidance on obtaining, documenting, and re-consenting research participants when required.
📌 Visit the Clinical Research SOP Library to review the latest versions and ensure your study procedures align with current requirements.