Key Things to Know About Research

1. Key Things to Know About Research Presented by: Emmelyn Kim, MA, MPH, CPH Office of Research Compliance (ORC)

2. ORC’s Mission • To provide comprehensive regulatory guidance to the research community to ensure the responsible conduct of research. • Our focus is on compliance through education and collaboration with the investigative community.

3. ORC Functions • Education and guidance for research teams • Regulatory support/advice post IRB approval • Site initiation visits • Consults for investigator initiated studies • Alert line to receive concerns: (516) 562-2019 • HIPAA Privacy & Conflict of Interest Issues • Auditing & monitoring studies for quality assurance (QA) & quality improvement (QI) • Routine GCP audits • For Cause audits • Pre-reviews prior to external audits (Federal agencies (FDA), sponsor)

4. You enter the realm of research? What Happens When…

5. GCP State Institution Regulatory Environment of Research Federal Investigator

6. Regulatory Environment of Research Examples • Federal • US Dept. of Health and Human Services (DHHS) • Office for Human Research Protections (OHRP) • US Food and Drug Administration (FDA) • Other regs: Health Insurance Portability & Accountability Act (HIPAA) • State • New York State (legal age, LAR, ICF req’s) • New York State Dept. of Health (controlled sub., labs) • Local • Site Facility Rules • Institutional – Health System Research Policies • Institutional Review Board (IRB) Policies

7. Then There is GCP… • GCP = Good Clinical Practice • Established by International Conference on Harmonization (ICH) • Created to establish a common standard for clinical research practice • An international ethical and scientific quality standard for designing, conducting, recording, and reporting human subject research. • E6 Guideline for GCP is found online: www.fda.gov/cedr/guidance

8. What’s the Purpose of GCP? • To ensure the protection of the safety, rights, and welfare of research subjects • To ensure the quality and integrity of research data collected

9. Good Clinical Practice (GCP) • Required for all clinical research studies that involve testing of investigational drugs, biologics, or devices • Recommended for all clinical research studies • Adoptedas the model for all studies within the Health System We remind PIs that they are ultimately responsible for the implementation and conduct of the research at their given site

10. What are Investigator Obligations? NSLIJHS IRB Researcher Registration Form: • Conduct research as approved by the IRB • Obtaining informed consent from subjects if required • Comply with Federal, State, & Institutional regulations • Complete human subject protection education - CITI • Cooperate with the IRB • Conform to Good Clinical Practice (GCP) Guidelines • Acknowledge potential routine or for-cause audits may occur

11. What Are Some Specific Obligations? Includes, but not limited to: • Conducting or supervising the investigation • Adhering to the protocol • Maintaining critical documents, source documents, and complete case report forms (CRFs), reg binder docs • Obtaining consent of subjects with the IRB approved consent form as appropriate • Notifying IRB with changes or updates • Documenting & reporting study or subject issues (SAEs, PV, UPs, etc.) • Administering investigational product and maintaining records • Cooperating with int/ext monitors & regulatory agencies

12. Researchers May Feel Like This…

13. We Have Something That Can Help

14. The Regulatory Binder Promote increased adherence to GCP by • Improving organization of regulatory documents • Providing guidance & tips • Providing tools & templates Easy to create your own! • Entire regulatory binder available online • Including tabs, templates, & tools Hard copy provided with IRB approval or by request

15. Regulatory Binder Materials Available online at: www.nslijhs.com/irb

16. Now You’re Organized What’s next?

17. Being Prepared for an Audit Potential Reviewers • External: OHRP, FDA, Sponsor • Internal: ORC • Routine GCP Reviews • For-cause Audits • Routine Financial/Grants Management Reviews: • Billing, Time & Effort

18. Goals of ORC Audits • Collaboration • Identify and resolve issues and problems together • Education • Consider the possibility of an “honest error” • Use mistakes as teaching tools • Opportunity for questions to be answered • Direction • Tools to get organized • Resources and how-to’s • Tips to improve process and quality • Development of corrective action plans

19. What We Look for During GCP Audits • Organization • Regulatory Binder Elements Including… • Staff delegation/signature log • Screening/enrollment log • CVs/licenses/COIs/required education • Lab permits/CV of director/normal ranges • Informed consent forms, protocols • IRB submissions & approval documents • SAEs/PVs/UPs

20. We Also Look at… • Investigational Product Accountability • Shipping & storage logs/forms • Sample Procurement/Tracking/Shipping records/logs • Case Report Forms (CRFs) – used to collect data for later analysis • Source documents – where data collected is first recorded (e.g. MRs, labs, reports) • Standard Operating Procedures (SOPs) • Subject files (inpatient & outpatient) • 10% Case Reviews

21. The Bigger Picture • The benefits of GCP reviews are to • Help improve the integrity of your study • Ensure compliance with various regulations • Ensure the well-being of the research subjects • Share the results with your team, re-evaluate processes & identify areas for continuous improvement • Education is a key element of study quality • Be aware & proactive • Regulations and policies evolve or surface

22. Tips for the Consent Form & Process • Place most recently IRB approved stamped consent form in plastic sleeve • Review consent once all parties sign for errors or omissions • File completed consent forms • Documentation is key! • Health System policy to document informed consent in medical record • The enrollment note

23. Sample Enrollment Notes Note: Anyone who signs a consent form is considered enrolled.

24. Remember… Informed consent is not just a form, but a continual process At each study visit or encounter document: • How the subject is doing on the study • Your clinical recommendation for continuation or discontinuation • The subject’s willingness to continue

25. What to Do With Signed Consents? Note: This is recommended, but can also depend on sponsor or site requirements.

26. What Increases Your Non-Compliance Risk? • When the line between clinical care and research are blurred • Not having the proper resources: staff, time, education, support • Lack of communication • Inadequate consent process • Not allocating time for documentation • Absence of internal monitoring

27. Final Key Tips • Obtain research education training for all study personnel - ensure everyone understands & agrees to their roles & responsibilities • Have a key documentation person - coordinator • Ensure needed resources…funds, space, study personnel, time to conduct research • Meet regularly with entire research team to discuss progress of study • Trust, but Verify! Assess all study aspects • Dedicate time to self-audit on a regular basis

28. Why Compliance Matters in the End What matters is not perfection, but understanding the downstream effects…. • Avoid actions by external regulators (FDA, OHRP, ORI, etc.) • Can affect publication of papers • May impact future research opportunities • Avoid future headaches…usable data, litigation • Building a body of knowledge from high quality research done ethically and responsibly • Contributing to the improvement of the health of populations  That’s what matters in the end!

29. Resources • ORC Web Site http://www.nslij.com/researchcompliance • Health System Research Policies Go to Healthport  click on Policies tab  either: Look under your facility and click on Research Policies  OR look under FIMR and click on Health System Research Policies • HIPAA & Researchhttp://privacyruleandresearch.nih.gov • FDA Regulations & Good Clinical Practice www.fda.gov • ICH E6 GCP: Guidance: www.fda.gov/fda.gov.cder/guidance/959fnl.pdf

30. It takes less time to do a thing right, than it does to explain why you did it wrong. -Henry Wadsworth Longfellow

31. Thank You Contact the ORC for any questions: Emmelyn Kim Manager • Email: ekim@nshs.edu • Phone: (516) 562-0339 Cyndi Hahn Administrator • Email: chahn@nshs.edu • Phone: (516) 562-2018