1. Good Clinical Practices and Best Research Practices at MU Health Betty Wilson, CIP, MS Senior Compliance Manager MU IRB Lori Wilcox, EdD Director of Academic Compliance, Corporate Compliance

2. Overview Three previous presentations provide framework for Good Clinical/Best Practices in Research IRB Basics including CITI training Informed Consent including participant safety and protection Research Documentation including reliable and valid results

3. Overview, cont. Provides assurance for quality data GCP = Ethics + Quality Data Timeliness Communication Standard Operating Procedures (SOPs) MU Health Best Practice examples

4. Foundations for Ethical Conduct Nuremberg Code 1947 Voluntary, Informed Consent, Risk Minimization Declaration of Helsinki (1964) Adaptation, Well-Being, Respect, Protection Belmont Report 1964 Respect for Persons, Beneficence, Justice ICH-GCP & ISO US utilizes these guidelines, but has not adopted FDA endorsed in 1997, but not fully adopted Code of Federal Regulations Title 21 (21 CFR)

5. Focus on MU Health MU IRB follows Good Clinical Practices (GCP) from ICH guidelines to the extent they are required by the FDA regulations If your sponsor/study requires strict adherence to ICH guidelines, you will need to explore these in more detail CITI training has an optional module that discusses ICH guidelines

6. Foundations for Ethical Conduct, cont. Code of Federal Regulations Title 21 (21 CFR) 21 CFR 11 – Electronic Records and Signatures 21 CFR 50 – Protection of Human Subjects 21 CFR 54 – Financial Disclosure 21 CFR 56 – IRB 21 CFR 812 – Investigation Device Exemptions 21 CFR 814 – Pre-market Approval of Med. Devices

7. GCP in Practice What does it look like in day to day practice at MU?

8. Timeliness Check results in real time Enter data the same day as activity Complete information while subject present Schedule subject appointments in advance (next visit, all visits)

9. Reminders For the Subject Fasting draws Urine collection Unused drugs/diaries Research Team How to process samples Prompts in case report forms

10. Communication With team members With sponsor With IRB With Corporate Compliance With ancillary departments (radiology, pharmacy, pathology)

11. Checklists & Organization Know who is supposed to do what…and when! Organization from application through follow-up is essential

12. Standard Operating Procedures (SOPs) Outline required tasks Sign-off requirements Checklists completed Limit deviations Ask for samples or assistance from IRB, Corporate Compliance, Research Peers

13. Key Aspects Know sponsor’s requirements Double check results/entries Question items that look strange

14. Research Best Practices at MU Health Streamlined from Protocol through data reporting Research Billing Coverage Analysis Research pricing/discounts Data Dictionary Form & FSC 152 Enrollment logs weekly/monthly IRB aware of pertinent changes and adverse events

15. Research Best Practices at MU Health, cont. All areas – organization & continuous improvement MOI Grab & Go Binders Appointment change alert CRC Case Report Forms Fiscal/financial management & spreadsheets Oncology Progress Notes in EMR

16. Coming Soon EMR notes for Research Document Management Committee (DMC) Updated SOPs from SOM Clinical research training, Informed consent, Source documentation, AEs, Drug/device procurement & storage, Monitoring visits, Internal & external audits Ability to change FSC to 152 (research) Additions to eCompliance