1. Office of Human Research Protection Georgia Health Sciences University

2.  Quality Systems approach to ensuring all aspects of research conduct and compliance are addressed

3.  Old Audit ◦ Review of all records ◦ More of a monitoring visit ◦ Focused on finding errors  New Assessment ◦ Focused on PI oversight and involvement ◦ Looking for trends ◦ Focus on compliance and educating study staff

4.  Level 1 ◦ Management Controls ◦ Personnel Controls ◦ Facility Controls  Level 2 ◦ Investigational product control ◦ Safety controls ◦ Records, documents and revision controls  Level 3 ◦ Corrective and preventative action controls

5. FacilityControls Investigational Product Controls Records, Documents, & Revision Controls SafetyControls PersonnelControls Corrective & PreventiveActions ManagementControls

6. The PI is ultimately responsible for the conduct of the study and must take an active role in ensuring the study is conducted in compliance with all applicable regulations, policies, and laws. Responsibilities include, but are not limited to:  Appropriate delegation of study related tasks  Adequate supervision of the conduct of the research  PI should ensure there are standard operating procedures for all aspects of the study specific to the research site  The PI should provide management oversight and supervision

7. The PI must ensure:  Education, training, and expertise of investigative staff  Training measures taken when nonconformities are identified  Ongoing training efforts and study-specific training  Personnel involvement and impact on compliance

8.  External facility ◦ Outside laboratories  Internal facility ◦ Equipment ◦ Space

9. Systems to control Investigational products (IP) including the areas of:  Receiving  Storing and security measures/ access controls  Dispensing  Overall accountability  Use  Return  Reconciliation  Process for approving personnel

10.  Adverse event reporting  Medical oversight ◦ Physician involvement in (inclusion/exclusion) ◦ Appropriate or over delegation  Laboratory and specialty testing  Human research subject safety/ ethics ◦ IRB approval for all changes made to protocol  Protocol deviation management

11. The PI must ensure:  Data collection, including source documentation and integrity and investigator data management process  Regulatory documents are present and organized  Control to ensure security and confidentiality of the records  Delegation of Authority and training records (to verify record/data accuracy )  Documentation of training for research team

12.  Internal quality assurance and quality control  Monitoring process  Internal assessment capabilities

13.  May see more request for documentation of PI involvement ◦ Training records ◦ Meetings documentation ◦ E-mail correspondence  Audits will not review every subject record ◦ Research team will be responsible for finding additional issues and correcting based on instructions for the auditors

15. QUESTIONS