Principal Investigator's Compliance Assessment

PICA Form Version 1.0 - Current as of 23-Jan-2024

An annual clinical research Compliance Assessment is required to be completed for all greater than minimal risk active studies being conducted under the University of Pennsylvania's Human Research Protection Program that do not have a sponsor appointed study monitor.

The Compliance Assessment should be completed annually - within 90 days of the IRB approval expiration date. Please do not upload the Compliance Assessment into HS-ERA. Submit the completed form to OCR Compliance by completing the form below.

• Document any finding and comment on any question for which the answer requires clarification
• If the study has been audited/monitored during the 90 days prior to IRB approval expiration date, some of the questions might be answered by referring to the information provided by the audit/monitoring
• File all the documentation regarding the compliance assessment in the Monitoring section of the Regulatory Binder to demonstrate ongoing assessment of the research conduct.

A list of all questions included in the following survery can be found here: List of PICA Questions for REDCap Final.pdf

The OCR can be reached for support related to any aspect of the assessment:

• OCR contact information: psom-ocrcompliance@pobox.upenn.edu
• For helpful tools and templates as such adverse event log, monitoring visit log or IP accountability log, refer to the "Forms, tools and templates" on the OCR website (https://www.med.upenn.edu/clinicalresearch/forms-tools-templates.html)

Finally, please be sure to verify that the provided e-mail address for the Principal Investigator is correct before submitting the form.

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