About the Clinical Trial Contracting Unit
The Clinical Trial Contracting Unit is responsible for negotiating and concluding corporate-sponsored clinical trial and related enabling agreements. The contract professionals work collaboratively with key sponsor, CRO and internal stakeholders, including departmental business administrators responsible for negotiating the budget and payment schedule portion of the agreement. CTCU also collaborates with other Penn offices, including the Penn Center for Innovation concerning intellectual property related matters, the Office of Research Services, the IRB and the Office of General Counsel, as necessary.
Key functions of the CTCU include:
- Negotiation, execution and conclusion of clinical trial and related enabling agreements;
- Serving as a liaison with sponsors, CROs and faculty/staff to help ensure effective decision-making regarding contractual issues;
- Collaborating with OCR colleagues and others on initiatives to enhance the clinical research experience for subjects, faculty, staff and sponsors.
Representative Categories of Agreements CTCU Negotiates:
- Corporate Sponsored Clinical Trial Agreements – including Master CTAs with Sponsors and CROs.
- Amendments to Corporate Sponsored Clinical Trial Agreements.
- Work Orders/Project Agreements off Master Corporate Sponsored Clinical Trial Agreements.
- Sub-awards to Corporate Sponsored Clinical Trial Agreements.
- Protocol related Confidential Disclosure Agreements.
- Data Use Agreements as necessary components to Corporate Sponsored CTAs.
- Material Transfer Agreements as necessary components to Corporate Sponsored CTAs.
- Laboratory Research Agreements associated with clinical trials (Penn Core Labs)
- Agreements for protocol development;
- Reservation of rights letters in connection with submission of applications for grants for clinical trials to for-profit companies.
CTCU Parallel Review:
- Parallel Review initiates CTCU’s review and negotiation of the clinical trial agreement simultaneously with the budget negotiations.
- Parallel Review generally is more efficient and serves to minimize protocol activation delays.
- Complete and submit the Parallel Review of Corporate Contracts form when creating the PennERA account.
Please use the mailbox below only for requests related to corporate-funded clinical trial agreements (e.g., requests for parallel review of agreements or requests date extension):
- Clinical Trial Contacting Unit
Office of Clinical Research
Perelman School of Medicine
322 Anatomy-Chemistry Bldg.
3620 Hamilton Walk
Philadelphia, PA 19104-6061
Phone: (215) 746-8913
All non-monetary or material transfer agreements should be submitted via the Research Inventory System (RIS): http://bit.ly/sJezea (Pennkey required)
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