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Contracts

Contracts. Penn State Research. Penn State Hershey Research. Dan Notterman, MD Vice Dean for Research Sheila Vrana, PhD Associate Dean for Research. Contracts Team x4196. Barb Suchanec. Lou Porter. Robinn Moyer. Paul Primrose. Stacey Cleary. Who’s my person?. Where do I start?.

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Contracts

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  1. Contracts

  2. Penn State Research

  3. Penn State Hershey Research • Dan Notterman, MD • Vice Dean for Research • Sheila Vrana, PhD • Associate Dean for Research

  4. Contracts Team x4196 Barb Suchanec Lou Porter Robinn Moyer Paul Primrose Stacey Cleary

  5. Who’s my person?

  6. Where do I start? • CDA – Jill Wagner, Tech Development • Before you can see Sponsor information, you agree to keep it confidential

  7. Internal Submission • ePIAF • Internal form for approval • Originally developed for grant applications • Database for reporting • Declare conflicts

  8. Into the queue • ePIAF generates an OSP# • Email to CTO and ORA • Schedule budget feasibility meeting

  9. Sponsor Government, Industry, Foundation, Department Principal Investigator / Department Agreement Execution/ Award $ Office of Research Affairs Clinical Trials Office HSPO/IRB Office of Technology Development Clinical Research Center Marketing & Communications Other Biosafety Conflict of Interest COM Controller’s Office PFS/Finance Public Health Sciences Research Quality Assurance Risk Management

  10. The Contract • Establish the rules before the game. • Players • Positions • Protection • Payment • Problems

  11. The Players • Penn State and the Medical Center • The Investigator • The Sponsor • Maybe a CRO

  12. What does Sponsor want? • Test a new drug or device • Test a new use of an approved drug/device • Control cost • Enroll fast • Own and control the data • Publications • Intellectual Property

  13. What do We Want? • Help our patients • Participate in research • Publish • Use research data internally • Teach our students • Maybe generate a little margin

  14. Set the rules • Everyone follows the laws as they apply to their role • Everyone protects the patient • Everyone gets to publish • Everyone agrees to share

  15. What’s in the Contract • Relationship of the Parties • Clearly state that neither party is an agent or employee • Independent contractors • Notices • To assure that both parties trust that communications are received • Where to send • What is acceptable

  16. What’s in the Contract • Term/Termination • Effective Date and Expiration • Sets period for budget/fund in IBIS • Early termination • Breach • Safety • Sponsor said so • Change in PI • Effective of termination

  17. What’s in the Contract • Use of Name • Approval of the other party • Except reporting • Biosketches / grant applications • Assignment • Sponsor assigns to CRO • Survival Clauses

  18. Articles in the Contract • Order of precedence • Contract vs Protocol • Governing Law • Pennsylvania or silent • Payment / Invoicing Addresses

  19. Publication • Usually multi-center publication first • ICMJE and Clinicaltrials.gov both require study results to be public • Allow sponsor review for confidential info / patent

  20. Confidentiality • Mark things confidential • Protect confidential things • Set a term, but within rules for publication

  21. Intellectual Property • If something new develops, who owns it • Agree to disclose new developments • Applies to PI and all study staff

  22. Indemnity • “the act of making another “whole” by covering or guaranteeing any costs are incurred contractually in a trial • Legal process and fees • Expenses required to care for study subject

  23. Indemnity • Subject injury • Sponsor’s use of data • Product liability • Unless… • Negligent • Don’t follow protocol/instructions • Natural progression of disease

  24. Subject Injury • Sponsor reimburses charges related to injury • Institution arranges treatment • Contract provision matches consent form

  25. AAHRPP • Voluntary program • Protect the participants • Data / Safety Monitoring Board • On-site monitoring • Guest Account Access Form • Share adverse event info, during and 2 years after study

  26. The Stars Align! • Final contract language and budget • CTO does final congruence • Contract Person assembles papers • PI signs first • Vinnie Falvo signs for COM • Kevin Haley signs for HMC

  27. FULLY EXECUTED AGREEMENT! • Statement of Award • Establishes fixed dates for IBIS • Awards a specific dollar amount

  28. Wildcards • Master Agreements • Amendments • Export Control • Extension Requests

  29. Federal Flow-through • FDP templates • Sort of like a Master Agreement • Annual project period

  30. Be involved! • ROAR • RQA Lunch Lectures • IRB workshops • Tech Development Workshops • ACES

  31. Questions?

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