Monitoring during the Trial
The Principal Investigator Compliance Assessment (PICA) is a tool which can be used to monitor or assess the overall conduct of a clinical research study. This document is required for all active, high-risk studies conducted at Penn Medicine.
PICA Form FAQ
PICA is an acronym that stands for Principal Investigator Compliance Assessment. The purpose of the assessment is to document the quality control activities conducted by studies that are greater than minimal risk, but do not have a Sponsor-assigned monitor.
Studies that are considered greater than minimal risk that do not utilize a Sponsor-appointed monitor must complete a PICA form annually.
The IRB’s risk determination is included in the initial approval letter. For trials that are minimal risk, the following language will appear in the IRB initial approval letter: “This study has been determined to pose minimal risk to subjects.” IRB approval letters for trials that are greater than minimal risk do not contain this language.
PICA forms are required to be submitted annually, within 90 days of the IRB approval expiration date. Usually, PICA forms are completed by teams in parallel with their continuing review requirements.
No. The PICA form is submitted to the Compliance team in the Office of Clinical Research. Please do not submit completed PICA forms to the IRB.
Yes. Any member of the study team can complete the form. Once the survey is completed, the PI must approve of the content of the form via electronic signature on REDCap before they are accepted by OCR Compliance.
Once the REDCap survey is completed, an e-mail notification to the e-mail address listed in the “Principal Investigator’s E-mail Address” will send, prompting the PI to review the form and provide their attestation to its contents via electronic signature.
Since early 2024, the PICA form has been exclusively available as a REDCap survey. This change was made to reduce the physical document burden on teams and streamline the PICA process. You can access the survey by visiting the following link: https://redcap.med.upenn.edu/surveys/?s=RTJHWJ78973DEXYW
The OCR Compliance team will review the PICA submission - usually within one business week. If there are any issues, the team will be asked to address them before the PICA form is accepted. If the PICA is complete, without issues and signed by the PI, OCR Compliance will confirm its receipt of the PICA and file the form. Once approved, study teams should file a copy of their submitted PICA form in the study’s regulatory binder.
If you have any questions about the PICA form, please get in touch with the OCR Compliance team by sending an email to psom-ocrcompliance@pobox.upenn.edu.