Office of Clinical Research

• Legal Services
• About OCR Legal Services

About OCR Legal Services

The OCR Legal 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.  OCR Legal 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 OCR Legal 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 OCR Legal 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.

OCR Legal Parallel Review:

• Parallel Review initiates OCR Legal’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. 

Contact Us:

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):

OCR Legal
Office of Clinical Research
Perelman School of Medicine
322 Anatomy-Chemistry Bldg.
3620 Hamilton Walk
Philadelphia, PA 19104-6061
Phone: (215) 746-8913
Email: OCRLegalServices@pennmedicine.upenn.edu

All non-monetary or material transfer agreements should be submitted via the Research Inventory System (RIS): http://bit.ly/sJezea (Pennkey required)