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 firstname.lastname@example.org
OCR Legal Services
The Penn Medicine Clinical Research Legal group is responsible for negotiating corporate-sponsored clinical trial and related enabling agreements (CDA, NDA, DUA and MTAs). The legal group works closely with other Penn offices, including the Penn Center for Innovation, the Office of Research Services, the IRB and the Office of General Counsel. For questions please contact OCRLegalServices@pennmedicine.upenn.edu
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 email@example.com
OCR Regulatory Services
The Penn Medicine Clinical Research Regulatory unit provides subject matter 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 IDE’s, supports high risk first in human trials sponsored by Penn faculty, trains, and qualifies faculty sponsors, performs IND and IDE exemption determinations, and provides intensive guidance and support to faculty translating research from Penn labs into the clinical development. Visit the Regulatory unit's page for more information on services offered. Please contact us with question at firstname.lastname@example.org
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 email@example.com