Quality Systems Compliance Assessment

1. Quality Systems Compliance Assessment Office of Human Research Protection Georgia Health Sciences University

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

3. OLD AUDIT vs.QUALITY SYSTEMS ASSESSMENT • 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. Compliance Assessment • 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. Quality System Corrective & Preventive Actions Facility Controls Personnel Controls Management Controls Safety Controls Investigational ProductControls Records, Documents, & Revision Controls

6. Level 1:MANAGEMENT Quality Controls 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. Level 1:PERSONNEL Quality Controls 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. Level 1:FACILITY Quality Controls • External facility • Outside laboratories • Internal facility • Equipment • Space

9. Level 2:INVESTIGATIONAL PRODUCT Quality Controls 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. Level 2:SAFETY Quality Controls • 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. Level 2:RECORDS, DOCUMENTS & REVISIONSQuality Control 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. Level 3:CORRECTIVE & PREVENTIVE ACTIONS • Internal quality assurance and quality control • Monitoring process • Internal assessment capabilities

13. How this will effect you • 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