Penn Medicine Clinical Research

Office of Clinical Research

The Office of Clinical Research is organized into five support functions. Working together they facilitate research across Penn Medicine. The five support functions include finance, legal, operations regulatory and compliance. Brief descriptions along with contact information is provided below.

If you are not sure which group to direct your question to, send your inquiry to the General OCR Inbox.

OCR Financial Services

The Penn Medicine Clinical Research Finance team can support teams with the following (i) assisting with creating a Medicare Coverage Analysis (MCA) and a Prospective Reimbursement Analysis (PRA) (ii) helping teams develop and negotiate budgets, (iii) ensuring consistency across all clinical trial documents (MCA, Budget, CTA, ICF), (iv) creating the Penn Chart record so enrollment may commence, (v) auditing charges to ensure proper reimbursement, and (vi) closing out the study at completion. For more information and support contact the team at  psom-ocrfin@pobox.upenn.edu

Penn Medicine’s Office of Clinical Research Legal Services group (OCR Legal) is responsible for negotiating non-Abramson Cancer Center (ACC) clinical research agreements and related enabling agreements (e.g. CDA, NDA, DUA and MTAs) with industry partners for research involving human subjects who are required to give current informed consent and that requires IRB oversight. OCR Legal works closely with other Penn offices, including the Penn Center for Innovation (PCI), the Office of Research Services (ORS), the IRB and the Office of General Counsel. For questions, please contact OCRLegalServices@pennmedicine.upenn.edu. For more information about research-related contract negotiation at Penn please visit: Contract Negotiation.

OCR Operation Services

The Penn Medicine Clinical Research Operations unit creates workflows for research systems; PennCRMS, PennVault(s), REDCap, iConnect, DocuSign and PennChart. The unit provides Case Report Form (CRF) development for faculty led IITs as well as comprehensive monitoring for faculty held IND/IDE studies. They provide subject matter expertise to research teams on best practices for data stewardship, protection, and HIPAA. Additionally, they manage and report on required trainings. For questions for this team please contact psom-ocrops@pobox.upenn.edu

OCR Regulatory Services

The Penn Medicine Clinical Research Regulatory unit provides regulatory expertise to faculty conducting (i) investigator initiated clinical trials, (ii) non-clinical IND enabling studies, and (iii) manufacturing of investigational products. In addition, the team manages Penn held INDs and IDEs, supports high-risk first-in-human trials sponsored by Penn faculty, trains and qualifies faculty sponsors, reviews IND and IDE exemption requests, and provides intensive guidance and support to faculty translating research from Penn labs into clinical development.

OCR Regulatory provides both free and fee-for-service support.

For an overall description of services offered by OCR Regulatory, please visit this page.

For more information on fee-for-service support offered, visit Regulatory fee-for-service page.

Please contact OCR Regulatory with for additional information via email at psom-ind-ide@pobox.upenn.edu.

OCR Compliance Services

Provides resources, guidance and training to promote compliance with federal and local regulations and adherence to the highest professional and ethical standards. This is accomplished via providing CT.gov support, support teams preparing for external audits and FDA inspections, conducting annual compliance reviews, and team trainings. For our assistance and guidance please contact us at psom-ocrcompliance@pobox.upenn.edu