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

1. The QA/QI ProcessHuman Research Subjects ProtectionHuman Investigation CommitteeTracy Rightmer, JD, CIPCompliance Manager

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. 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. Two Critical Program Processes • Quality Assurance • Quality Improvement

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

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

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. 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. 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 GeneralConsiderations for Clinical Trials, 62 Federal Registers 66113 (December 17, 1997) • International Conference on Harmonization, Good Clinical Practice Guidelines • Published AAHRPP Accreditation Standards

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. 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)