Post Approval Monitoring (PAM)

The HRPP will notify the PI via email with a link to REDCap to address questions regarding Post Approval Monitoring. PI’s will have 30 business days to complete the questions within REDCap. If PI’s do not respond to the HRPP this will be considered noncompliance with our policy and may result in a hold on future submissions to the IRB, a full audit, or involvement of the Associate VP of Research Administration.

After receipt of the information requested via REDCap, the HRPP staff will review the information and will follow up with investigators within 15 business days with any additional requests, clarifications, interview requests, and possible site visit. Within 30 business days the HRPP will have a case report sent to the PI.

The questions that will be sent to investigators will address questions regarding the protocol, consent forms and supporting study documents. In preparation of addressing the questions it is important to carefully and objectively review your approved protocol and ensure that all staff are carefully following all activities as described and approved by the IRB. All IRB study procedures must be followed and if any changes are needed to the approved protocol, an amendment must be submitted and approved. The HRPP cannot stress the importance of following the approved protocol. Even small changes from the approved protocol may be of great concern to the IRB, federal regulatory agencies, and internal and external auditors.

The goal of PAM is to help support the research team, and facilitate research by ensuring that the approved IRB protocol and University Policy are being followed.  The HRPP can also help researchers by identifying deficiencies so that the research team can put a plan in place for success and correct any deficiencies.

Upon completion of a PAM activity, the HRPP will prepare a case report that will be sent to the investigator and submitted both to iStar and RedCap. The case report will provide study teams with an overview of the findings and any potential follow-up actions that may be needed. Findings may include:

• No issues found and no action required.
• Recommendations or suggestions for consideration by the PI, such as sharing current best practices.
• Additional education for the principal investigator and/or study staff.
• Items requiring action – a request that an amendment or unanticipated problem be submitted.
• Forwarding to IRB for consideration of non-compliance findings.

If a concern or complaint about the conduct of a project is discovered or reported to the HRPP staff, any member of the IRB, or other administrative official, an audit for cause may be initiated. Audits for cause may occur at any time. The determination of the need for an audit for cause shall be made by the IRB Chair, HRPP QA/QI Team, Director, or HRPP Staff. An audit may be project-oriented (focused on a specific project) or research-oriented (focused on all the projects of a particular researcher). The PI of a project that has been selected for an audit for cause shall be notified at least one (1) working day in advance of the audit.

On site Assessment may be conducted by HRPP Staff.  The role of the HRPP staff is to observe research activities, assist and educate the PI and research team by identifying deviations from the approved protocol. The HRPP staff will help identify who may be the best person to help with implementation of any required changes, and will be responsible for documenting the findings of the PAM assessment.

This form is for researchers to use to conduct self-assessments of their IRB approved projects to ensure they are being conducted in compliance with the approved procedures and IRB regulations and policies. The USC IRB requires researchers to conduct self-assessments at least annually for any project that lasts longer than one year, and may request self-assessments be reported to the USC IRB. Please keep copies of completed assessments with your IRB related records.

USC Self-Assessment Tool

Some of the potential benefits that may be gained from a self-assessment include but are not limited to:

• Increased understanding of HRPP regulations and policies.
• Identifying areas of strength and/or need for improvement in research practices.
• Increased communication with IRB staff.

The IRB estimates that the self-assessment will take ~ 1 hour to complete or less.

• The IRB-approved version of the informed consent or assent document was not used.
• No informed consent obtained prior to study procedures.
• The informed consent document on file is not complete (i.e., only the page containing the signature is on file).
• Dates on informed consent documents for participant and researcher are not the same.
• CITI training for study personnel is expired or is not on file.
• Study personnel do not have a current conflict of interest disclosure on file with the COI office.
• Study documents not stored as indicated in the approved protocol OR stored with a linking list.

Progress updates will be used for all exempt and expedited studies that were not assigned a continuing review by the IRB. USC is committed to best practice. The Progress Update will provide the USC HRPP with information about study status. Progress Updates are not continuing reviews, but part of post approval monitoring. Investigators will receive auto acknowledgement regarding the Progress Update.