1. The QA/QI Process Human Research Subjects Protection Human Investigation Committee Tracy Rightmer, JD, CIP Compliance Manager

2. 2 HIC Human Research Subjects Protection Compliance Program Goals – Strengthen and Facilitate: –Safeguards for the rights and welfare of human research subjects –Responsible conduct of research involving human research subjects

3. 3 Current HIC Compliance Program Assurance of Compliance to the “Federal Policy” (Yale/DHHS) (Federal Wide Assurance or FWA) and to Ethical Principles (Belmont Report) Compliance after HIC approval

4. 4 Two Critical Program Processes Quality Assurance Quality Improvement

5. 5 Quality Assurance Assess Compliance (regulatory, policy, approved protocol, etc.) Resolve/correct problems and discrepancies Verify Compliance

6. 6 Quality Improvement Provide insight to where systems and processes are ineffective Collaborative with PI and study staff More creative and educative process Change or add processes/procedures/guidance, etc.

7. 7 QA/QI Stages Introduction/Scheduling PI/Investigator Interviews Staff Interview Review of Regulatory Binder (all vital study documents -- protocol, consents, HIC correspondence, sponsor correspondence, SAE/AE reports, Investigator’s Brochure, etc.) Review of Subject Study Records

8. 8 QA/QI Stages Draft Findings Report Release of Findings Report Tracking of Corrective Actions/Plans, if applicable Closure (

9. 9 What Does the Reviewer Want to See? Documentation that you are following your approved protocol Proper use of consent forms Following inclusion/exclusion criteria Following study procedures Experimental drug/device accountability Following Data and Safety Monitoring Plan (DSMP) Following AE collection, reporting, data review

10. 10 Can You Prepare Ahead of Time? Complete the self-assessment checklist Create a list of all participants in your study Review each consent form & make sure it’s the correct version & has been signed/dated properly by the subject If you find a problem with a consent, make a note in the study file and fix the problem as soon as possible (notify HIC) Make sure you have all HIC correspondence in the Regulatory File

11. 11 Authorities and References 45 CFR 46, Protection of Human Subjects 21 CFR 50, Protection of Human Subjects 21 CFR 56, Institutional Review Boards 21 CFR 11, Electronic Records 21 CFR 54, Financial Disclosure by Clinical Investigators Applicable DHHS Office of Human Research Protection policy, guidance, and directives (including OHRP Guidebook for Human Subject Protections ) Specific grant/contractual requirements (as applicable) FDA Information Sheets; policy statements and guidance documents OHRP, “Dear Colleague Letters ” and Determination Letters FDA International Conference on Harmonization, Guidance on General Considerations for Clinical Trials, 62 Federal Registers 66113 (December 17, 1997) International Conference on Harmonization, Good Clinical Practice Guidelines Published AAHRPP Accreditation Standards

12. 12 Authorities and References 21 CFR 312, Investigational New Drug Application 21 CFR 812, Investigational Device Exemptions The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects in Research, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research-, April 1979 Applicable National Institutes of Health policy, guidance, and directives

13. 13 Authorities and References HIC policy, procedures, and guidelines Yale University policy, procedures, and guidelines Connecticut State Statutes & Directives Yale University Federal Wide Assurance #FWA00002571 Specific grant/contractual requirements (as applicable)