Penn Medicine Clinical Research

Compliance Services

The mission of the OCR Compliance is to facilitate compliant research that generates high-quality data from which scientific conclusions may be drawn, while simultaneously protecting human subjects from harm. The primary way this is accomplished is through the compliance review program. OCR compliance reviews seek to identify areas of quality variance and noncompliance so that we can partner with research Investigators and their teams to achieve compliance through training and communication. OCR  compliance is committed to supporting clinical research efforts across Penn Medicine and fostering effective research compliance.

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OCR accomplishes this through its support to two key constituencies:

  • Penn’s Investigators
  • Penn’s Clinical Research professional staff

OCR compliance’s focus is on:

  • Raising awareness of the importance of conducting research in compliance with regulations and institutional policies
  • Directing the community to policies and resources that describe what is required
  • Communicating the importance of asking questions and identifying concerns related to regulatory compliance
  • Providing support for compliance with new regulations

Most study teams will not be contacted for a compliance review by our office. If you are interested in the compliance review process you can review SOP 200 via the link on this page. Any teams that have a concern about the conduct of their particular study are encouraged to contact our office and request a compliance review. Requests will be accommodated whenever feasible based on the current audit schedule. In addition to providing reviews on request, OCR Compliance Services provides trainings to study teams on request.

Most teams will interact with OCR Compliance Services when they submit Principle Investigator Compliance Assessment (PICA) at the time of their continuing review submission with the IRB.

For more information on the OCR Compliance you can email: psom-ocrcompliance@pobox.upenn.edu

The following guidance is designed to help the clinical research team navigate the ClinicalTrials.gov (i.e., the Protocol Registration and Results System or PRS system) registration process. If you have any further questions about the process of submitting information to ClinicalTrials.gov, PRS has published a detailed PRS Users Guide found at https://prsinfo.clinicaltrials.gov/prs-users-guide.html or contact OCR at ocrctgov@pobox.upenn.edu.

•  Standard Operating Procedures (SOPs) for Clinical Research

•  Add button to PRS account redcap survey

•Add FAQs button that will take visitors to old CT.gov page on OCR website