Post Approval Monitoring

The goals of the IRB Office’s Compliance Unit are to enhance the caliber of research performed at Phronetik and to increase the effectiveness of the Human Research Protection Program (HRPP) through program oversight, education, and outreach.

 

One way in which the Compliance Unit meets these goals is through post-approval monitoring. During the evaluation, a senior IRB compliance analyst will assess research activities, identify areas of concern, provide guidance in implementing corrective actions or best practice recommendations, and prepare a monitoring observations report.

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The Compliance Unit performs various post-approval monitoring activities to ensure the rights and welfare of research participants are protected. The Principal Investigator (PI) and their research personnel must fully cooperate with all routine monitoring conducted by the IRB, regulatory agencies, funding agencies, or study sponsors. In addition, the PI must implement the appropriate corrective and preventative actions to resolve any observations and ensure that their research aligns with applicable federal regulations, state laws, and institutional policies.

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Self-Assessments and Visits

 

Post-approval monitoring is a routine compliance review of IRB approved studies. The review is an educational process that bolsters best research practices. A senior IRB compliance analyst, who is internal to the IRB Office, performs the review. Monitoring typically consists of a self-assessment or in-person review of adherence to the IRB approved protocol, assessment of study records and participant files, evaluation of other research activities, and may include or be limited to an observation of the consent process. All active human research studies, including those where the Phronetik IRB ceded IRB review to an external IRB, are subject to routine monitoring, except those determined to qualify for exempt status. The Compliance Unit randomly selects studies for monitoring; however, the Board, or IRB Office staff may request a study undergo monitoring, often based on the following criteria:

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• Risk level of the study

• Studies involving investigational new drugs (INDs) or devices (IDEs)

• An investigator-held IND/IDE

• Studies enrolling vulnerable populations

• Studies requiring more frequent than annual review by the IRB

• Randomly selected from open non-exempt studies in eIRB+

 

Routine Corrective and Preventative Action (CAPA) Plan Assessments

 

CAPA plan assessments are post-approval monitoring activities consisting of a routine compliance review of CAPA plan implementation and adherence. A senior IRB compliance analyst performs the review based on information provided by the study team in a completed or acknowledged Reportable New Information (RNI) application. Monitoring consists of an in-person assessment or remote self-assessment that the proposed CAPA plan is specific, timely, and measurable, and a review of study records and participant files related to implementation and adherence to the plan. All completed or acknowledged RNI applications containing a CAPA plan are subject to routine monitoring. The Compliance Unit selects CAPA plans for monitoring at random; however, the IRB may request a specific plan undergo routine monitoring or directed review. The IRB may request a review of a CAPA plan based on the following criteria:

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• Seriousness of the reportable event

• Feasibility of the proposed CAPA plan

• Randomly selected from completed or acknowledged RNI applications in eIRB+

 

Recruitment Materials and Processes Review

 

Routine post-approval monitoring may also occur for posted recruitment tools. Monitoring typically consists of identification and internal review of a posted recruitment tool. A senior IRB compliance analyst will ensure that researchers adherence to Phronetik's guidelines for recruitment materials, the IRB approved protocol, and only use IRB approved materials. All posted recruitment tools for Phronetik research studies, both in-person or online, are subject to routine monitoring. The Compliance Unit randomly selects recruitment tools for monitoring; however, IRB Office staff may identify a recruitment tool to undergo review if it appears to not adhere to our recruitment requirements. Selection is based on the following criteria:

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• Randomly selected from posted materials

• Inclusion of prohibited elements

• Prohibited recruitment strategy (such as general ads or flyers)

• Missing required elements

 

Overview of The Review Process

 

Post-Approval Monitoring (Self-Assessment)

A senior IRB compliance analyst will contact the Principal Investigator (PI) and primary study contact via email to inform them that they have been selected to undergo post-approval monitoring. The compliance analyst will ask the PI to review their own study within 30 days of initial notification and return their findings, in the form of completed post-approval monitoring checklists, to the IRB compliance analyst for review.

If the study identified for post-approval monitoring is ready to be closed with the IRB, the PI is still required to engage in the post-approval monitoring activity and complete the checklists. The PI may submit the study for closure once the PI has completed the post-approval monitoring activity and the close-out notification has been sent by the senior IRB compliance analyst.

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Post-Approval Monitoring (In-Person Visit)

For post-approval monitoring visits, the compliance analyst will provide the PI and their designee with a selection of days to choose from to schedule the visit. The compliance analyst will ask the PI to review their own study and return their findings to the IRB compliance analyst a week before the visit. The compliance analyst will ask the PI to provide the following information when scheduling the activity:

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• PI and study staff availability

• Access to study files and regulatory documentation

• Access to participant records

• Space in which to review study documents

• Time to discuss with the PI or designated team member

 

Post-Approval Monitoring (CAPA Plan Assessment)

For CAPA plan assessment visits, the compliance analyst will provide the PI and their designee with a selection of days to choose from to schedule the visit. The compliance analyst will ask the PI to provide the following information when scheduling the activity:

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• PI and study staff availability

• Access to study files and regulatory documentation related to the CAPA plan

• Access to participant records related to the CAPA plan

• Space in which to review study documents

• Time to discuss with the PI or designated team member

 

For remote CAPA plan self-assessments, the compliance analyst will contact the Principal Investigator (PI) and primary study contact via email and inform them that they have been selected to undergo a CAPA plan self-assessment. The compliance analyst will ask the PI to review their own CAPA plan implementation within 30 days of initial notification and return their findings, with supporting documentation, to the IRB compliance analyst for review.

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Post-Approval Monitoring (Recruitment Review)

A senior IRB compliance analyst will contact the Principal Investigator (PI) and primary study contact via email and inform them that one of their recruitment tools will undergo post-approval monitoring.

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Preparing For a Monitoring Visit

The compliance analyst schedules the visit with the PI and their study contact, making every attempt to accommodate their schedules. Once scheduled, the compliance analyst will provide the PI and study contact with a link to the assessment checklists to complete the forms and assess their study in advance of the visit, as applicable.

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The review activity evaluates areas such as, but not limited to, the following:

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• Regulatory and IRB documentation

• Protocol adherence

• Participant recruitment, selection, and payment procedures

• Participant enrollment and corresponding records

• Informed consent procedures

• Participant payment

• Document and data retention and storage practices

• Confidentiality and privacy practices and processes

• Clinical trial requirements

• CAPA plan implementation and adherence

 

From the time of initial correspondence to the date of the visit, the research team is encouraged to contact the compliance unit with any questions or concerns related to the activity.

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Closeout and Follow-Up Actions

 

For remote post-approval monitoring, the senior IRB compliance analyst will communicate with the PI and study contact by email while reviewing their study. Upon completing an in-person post-approval monitoring visit or CAPA assessment visit, the compliance analyst may discuss the observations with the PI and their designee(s) while on-site or schedule a follow-up meeting after the visit. The PI will receive a written report detailing the observations made during the post-approval monitoring visit. The report may include recommended or required actions.  The compliance analyst will bring to the IRB compliance manager and/or executive director any issues that may pose an immediate threat to research participants or constitute serious non-compliance.

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If the monitoring assessment yields reportable observations that need to be reported to the IRB, the correspondence from the compliance unit will detail the information the PI needs to submit to the Phronetik IRB for review and consideration via eIRB+. The Compliance Unit does not typically submit the full written report or assessment correspondence to the IRB but does retain them. Upon completing the monitoring activity, the compliance analyst will inform the PI and designee of any remaining required actions.  If all actions are complete, the compliance analyst will formally close out the post-approval monitoring activity and notify the PI.

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Required Corrective Actions vs. Recommended Corrective Actions

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Additional Information

For additional guidance please reference our SOPs, available on the SOPs webpage: