1. Cancer Clinical Trials Office Clinical Trials & Research Training Oct2014

2. BASIC CLINICAL TRIAL INFORMATION Cancer Clinical Trials Office Guidelines from Regulatory Agencies (ICH/GCP, FDA, IRB) Difference between clinical care and research Documentation present Protocol & Study Procedures Informed Consent Disbarment & Cases

3. Cancer Clinical Trials Office GCP (Good Clinical Practice) 21 CFR Part 11 – Electronic Records & Signatures 21 CFR Part 50 – Protection of Human Subject 21 CFR Part 54 – Financial Disclosure by Investigator 21 CFR Part 56 – Institutional Review Boards (IRBs) 21 CFR Part 312 – IND/IDE Application ICH (International Conference on Harmonization) E6 – Good Clinical Practice E2A – Clinical Safety Data Management E8 – General Consideration for Clinical Trials REGULATORY GUIDANCE

4. Cancer Clinical Trials Office FDA (Food & Drug Administration) IND Application & Process IDE Application & Process Form FDA 1572 (drug studies only) IRB (Institutional Review Board) Approve Protocol & supporting documentation Reviews & approves patient consents & materials Ongoing oversight for duration of the study REGULATORY GUIDANCE

5. Cancer Clinical Trials Office ROLES & RESPONSIBILITIES Oversees requirements for all new drug & devices in US Regulatory guidelines & forms FDA Federal, Pharmaceutical, etc Oversight of clinical trials & study specific requirements Sponsor SB Medicine Oversight of patients Performs the clinical trial per protocol Institution

6. Cancer Clinical Trials Office Clinical Care Medicare guidelines Adhering to standard of care guidelines Documenting standard notes based on visits Research ICH/GCP guidelines Adhering to protocol requirements Documenting additional details & information DIFFERENCES

7. Cancer Clinical Trials Office FORM FDA 1572

8. Cancer Clinical Trials Office INVESTIGATOR RESPONSIBILITY

9. Cancer Clinical Trials Office DOCUMENTATION If it’s not documented, it didn’t happen! Documentation is vital! Appropriate documentation (pathology report, chemotherapy orders, operation report, etc.) Every process, procedure & test performed for a patient that is taking part in the study needs to be present in the file Any medical records used to determine eligibility needs to be present in the file

10. Cancer Clinical Trials Office DOCUMENTATION

11. Cancer Clinical Trials Office PROTOCOL & STUDY PROCEDURES Identify all tests and procedures required Review and adhere to timelines Ensure completion and documentation of all items required Medical staff (MD, PA, NP, etc.) document medical evaluations Research staff (CRC, DM, etc.) document process and collect the records and information

12. Cancer Clinical Trials Office PROTOCOL & STUDY PROCEDURES

13. Cancer Clinical Trials Office NON-COMPLIANCE Non-compliance can result in failure to participate in research Loss of license for misconduct adversely affecting the safety of patients Continued failure to comply can result in disbarment http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/ucm 2005408.htm

14. Cancer Clinical Trials Office DISBARMENT CASES “Prominent Michigan Cancer Doctor Pleads Guilty: ‘I knew That It Was Medically Unnecessary’” Diagnosed and treated healthy patients for cancer Manipulating data in data and papers at Duke University Published in medical journals & patients treated on studies “proven” to work but rather were falsified to confirm researchers theory

15. Come to the Cancer Clinical Trials when you have a study, let us do all the work! Scheduling Regulatory preparations, oversight and compliance Quality assurance Financial management Study coordinator and data management SOLUTIONS

16. Cancer Clinical Trials Office Questions? THANK YOU