Clinical Trial Agreements
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Wednesday, March 20th @ noon
South Campus
Diefendorf Hall - Room 207
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This session will provide an overview of understanding clinical trial agreements and specifically offer insight on the reason contracts cannot be executed by the investigator or research site.
Key objectives:
- Why do we contract?
- What contracts generally arise in clinical research (e.g. NDA, CTA, DUA, BAA)?
- Which is more important: IRB or Contract Approval?
- What legal risks?
- HIPAA compliance
- MMSEA compliance
- Sunshine Act Compliance
- Non-profit tax exemption
- Export control
- What business risks?
- How the site gets paid
- How the data produced by the study is treated and who owns?
- How inventions that occur during the study are treated and who owns?
- How can each party use the other’s name/press releases
- Subject injury coverage
- What in the agreement do I need to know/understand?
- How do we manage confidential information?
- What permissions do I need before publishing research papers and/or press releases?
- Do the subject injury language and informed consent match?
- How long do the records have to be stored?
- When does the study team need to notify the sponsor about any activity in the study?
Presented by Conor Flynn, BS, JD, Industry Contracts, Clinical Research Office
Time will be allotted for questions and answers
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Open Research Office sessions bring together researchers and administrative personnel to address topics vital to launching, sustaining and completing a successful clinical or behavioral research project, including but not limited to:
- contracts and agreements
- budgets
- accounts receivable
- IRB submissions and regulatory compliance
- protocol development and regulatory guidance
- Central Study Registration, OnCore and Click support
- issues specific to your clinical or behavioral study
Bring your questions and specific concerns for on-the-spot, expert advice, guidance and instruction at any stage of your project. We're also seeking suggestions for future presentation topics.
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Open Research Office sessions bring representatives from the following UB administrative units out of their offices to consult with faculty researchers and research staff on their home turf:
Sessions are scheduled each month, rotating among four convenient locations:
- Downtown Buffalo Niagara Medical Campus
- Erie County Medical Center Campus
- South Campus/VAWNY Healthcare System
- North Campus
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Upcoming Session:
April 17, 2019 @ noon
North Campus - Baldy 107
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Upcoming Session:
May 22, 2019 @ noon
CTRC - Room 5002
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Upcoming Session:
June 21, 2019 @ noon
ECMC - Room C (3rd floor)
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