1. IU-CLINICAL TRIALS OFFICE A. Marisa King, MBA, MA, LMHC Clinical Research Contract Officer 1IU-CTO RCEP 19OCT15

2. IU-Clinical Trials Office (IU-CTO) Review and negotiate contracts on behalf of Indiana University Protect IU’s and the investigator's rights for all industry-sponsored clinical trials Ensure provisions are consistent with laws/regulations and IU policies (i.e., publication, intellectual property, indemnification) Define rights and obligations in mutually agreeable terms 2 IU-CTO RCEP 19OCT15

3. Common IU-CTO Contracts Confidentiality Disclosure Agreements Clinical Trial Agreements (including Subcontract Agreements and Compassionate Care Agreements) Amendments Master Agreements 3 IU-CTO RCEP 19OCT15

4. Laws & Regulations 21 CFR § 312 Subpart D–Drug studies 21 CFR § 812 Subparts C and E–Device studies 21 CFR § 54 Food and Drug Administration of the United States Department of Health and Human Services ICH Harmonized Tripartite Guideline for Good Clinical Practices Declaration of Helsinki World Medical Association Recommendations Applicable Health Insurance Portability and Accountability Act of 1996 rules and regulations 4 IU-CTO RCEP 19OCT15

5. Contract Parties Trustees of Indiana University – Legal name for IU – Actual party for any research conducted by and/or behalf of IU Outside company – Pharmaceutical/ device/ biotech/ CRO company that provides study support **Principle Investigator – Employee of IU who is responsible for the conduct of the study 5 IU-CTO RCEP 19OCT15

6. Confidentiality Disclosure Agreement Defines the terms and conditions to assure that the parties will maintain confidentiality of study- related information (i.e., data, methods and procedures) Ensures restricted use of information **May also be called: Nondisclosure Agreement, Mutual Confidentiality Agreement, etc. 6 IU-CTO RCEP 19OCT15

7. Clinical Trial Agreement Defines the scope of work required by the protocol and allocates risks/responsibilities Terms – Confidentiality – Indemnification – Intellectual property – Reporting requirements – Budget * May also be called: Clinical Services Agreement, Clinical Research Agreement, etc. 7 IU-CTO RCEP 19OCT15

8. Types of CTAs Company-developed – Pharmaceutical/device/biotech company is the “sponsor” – Protocol is developed by the company – IU is asked to conduct the study as one of many sites conducting the same study – Study is supported through the provision of funds/drugs/devices provided by the company Investigator-Initiated – IU is the “sponsor” – Protocol is written by the PI – Company may provide funds/drug/device to support the study 8 IU-CTO RCEP 19OCT15

9. Subcontract Agreements Negotiated after fully executed clinical trial agreement between IU and a company Agreement between IU and another entity to conduct certain services Budget is negotiated and managed through PI’s department 9 IU-CTO RCEP 19OCT15

10. Compassionate Care Agreements Emergency use provision [21 CFR 56.104(c)] Restricted access to experimental treatments Single patient with a serious or immediately life- threatening disease No SOC treatment available or SOC has not been helpful Not eligible for clinical trials No other options and may benefit from the experimental treatment Company agrees to provide treatment 10 IU-CTO RCEP 19OCT15

11. Amendments Contract modifications that introduce or cancel specifications or terms of the existing, underlying contract, while leaving intact the contract’s overall purpose and effect Most amendments address budget changes Must be in writing and submitted for review and negotiation to the IU-CTO through the routing system 11 IU-CTO RCEP 19OCT15

12. Master Agreements Umbrella agreement between a company and IU in which both parties agree upon a set of contractual terms and conditions for future clinical trials Each subsequent clinical trial is contracted with a study- specific agreement Study-specific agreements incorporate the terms of the Master Agreement and any unique conditions for that particular study, i.e., protocol title, PI name and budget Advantages: – Alleviates the need to negotiate the contractual terms for individual clinical trials – Increases efficiency and significantly expedites contractual process – Additional language may be inserted to study-specific agreement, if needed 12 IU-CTO RCEP 19OCT15

13. Clinical Trial Process Map *Target=90 days **Map key on slide 19 13 IU-CTO RCEP 19OCT15

14. Kuali Coeus (KC) Routing Must be routed by PI’s department – Clinical trial agreements – Amendments – Study-specific agreements Send to IU-CTO mailbox – Confidentiality agreements – Master agreements ** Subcontract agreements IU-CTO to draft PI Department: -Subcontract contact information -Statement of Work -Budget -Any other attachments/considerations 14 IU-CTO RCEP 19OCT15

15. KC Routing (cont.) CTA template (as provided by the company)* Protocol and ICF Budgets Emails Company contact information (name, email, address, #) Special considerations *Acceptable for Company to request CTO to draft contract 15 IU-CTO RCEP 19OCT15

16. Contact Information IU-CTOIndiana University Clinical Trials Office 550 University Boulevard AOC 5012 Indianapolis, IN 46202 Phone: 317-278-2546 Email: cto@iu.educto@iu.edu OnCoreIndiana University Clinical Trials Office 550 University Boulevard AOC 5014 Indianapolis, IN 46202 Email: oncore@iupui.eduoncore@iupui.edu 16 IU-CTO RCEP 19OCT15

17. IU-CTO Team Kenneth Carlson Director Phone: 317-278-2548 Email: khcarlso@iu.edukhcarlso@iu.edu Caren Geppert, JD Associate Director Phone: 317-274-2012 Email: geppertc@iu.edugeppertc@iu.edu A. Marisa King, MBA, MA, LMHC Clinical Research Contract Officer Phone: 317-274-5519 Email: mk26@iu.edumk26@iu.edu Kristy Brown, BS, CCRP Clinical Research Contract Specialist Phone: 317-278-9125 Email: armourk@iu.eduarmourk@iu.edu Daniel Littlepage Contract Coordinator Phone: 317-278-2546 Email: dlittlep@iu.edudlittlep@iu.edu 17IU-CTO RCEP 19OCT15

18. IU-CTO Team (cont.) Lindsay Mann OnCore Enterprise Manager Phone: 317-278-6638 Email: limann@iupui.edulimann@iupui.edu Christina Beard OnCore Application Coordinator Phone: 317-274-7906 Email: cmbeard@iupui.educmbeard@iupui.edu 18 IU-CTO RCEP 19OCT15

19. **Clinical Trial Process Map Key Denotes pop-up window with information and links (IU-CTO website) Dashed lineConstant communication between IU and Sponsor Solid line/HorizontalFinal decision has been made and next step in process is initiated Yellow lineIU department has decided to conduct study; Beginning of study initiation Solid line/VerticalDivides stages of the IU clinical trial process STAGE 1CDA PROCESS STAGE 2IU Investigator & Study Team study participation determination STAGE 3CTA PROCESS STAGE 4Final study preparations prior to FPV 19 IU-CTO RCEP 19OCT15