Post-approval monitoring (PAM) assessments are collaborative, education-focused reviews of the conduct of IRB-approved studies. The purpose is to improve research practices and protect research participants’ rights and welfare by providing guidance, resources, and educational support for conducting compliant human research. All active non-exempt human research studies are subject to routine monitoring, including those where Northwestern University or its affiliates ceded IRB review to an external IRB. Researchers engage with the Compliance Team on PAM assessments to ensure compliance with applicable federal regulations, state laws, institutional policies, and research best practices.

The Compliance Team provides post-approval monitoring checklists as a tool to ensure ongoing compliance with research regulations after a study has been approved by the IRB. It helps Principal Investigators (PIs) and staff confirm that key aspects of the study, such as informed consent procedures, documentation practices, and adherence to protocol, are properly maintained throughout the study’s duration. The post-approval monitoring (PAM) checklists serve to identify any areas needing correction and support continuous oversight, enhancing the protection of research participants and the integrity of the research process. All post-approval monitoring checklists are available to the research community and can be found on the IRB Office’s Checklists and Worksheets page.

The PI and their research personnel must fully and promptly cooperate with all monitoring conducted by the IRB, regulatory agencies, funding agencies, and 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.

The Compliance Team provides a summary of PAM activities to the IRB Chairperson’s Committee for their review. The IRB Office utilizes post-approval monitoring findings to assess and enhance human participants’ involvement in research at Northwestern and its affiliates through targeted training, education, and the ongoing development of study support resources.

Types of Monitoring Activities 

Self-Assessments and IRB Compliance Conducted Reviews

Post-approval monitoring self-assessments and IRB Compliance Conducted Reviews are routine reviews of IRB-approved studies. Monitoring may take place in-person or virtual (or a combination) and typically consists of an investigator self-assessment or compliance conducted review of:

• Adherence to the IRB-approved protocol;
• Assessment of study records and participant files; and
• Evaluation of other research activities.

The review may also include or be limited to observing the consent process.  The Compliance Team randomly selects studies for routine monthly self-assessment monitoring.  Generally, a PI will not be selected to undergo a routine self-assessment twice in the same year.  Additionally, at any time, the IRB Panel(s), Institutional Official, or IRB Office staff may request a study undergo monitoring, often based on, but not limited to, the following criteria:

• 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 an annual review by the IRB
• Studies where the PI is new to the role in non-exempt human research conducted at Northwestern and its affiliates

Study Status Assessments for Studies without an IRB Approval Expiration Date

The study status assessment is a routine post-approval monitoring activity conducted on non-exempt studies approved or renewed by the IRB without an IRB-approval expiration date (i.e., do not require continuing review).

The PI or designee first completes and returns the checklist, Studies Without an Expiration Date (HRP-433). An IRB Compliance Analyst then performs the review based on the information provided by the study team in the completed self-assessment checklist. Study Status Assessment monitoring also includes study status evaluation and document retention activities. If the study status meets the criteria for closure, the assessment will include confirmation that the PI has submitted a continuing review application to close the study.

All active human research studies without an expiration date, including those where Northwestern or its affiliates ceded IRB review to an external IRB, are subject to monitoring, except those determined to meet the exempt criteria. The Compliance Team randomly selects studies for monitoring; however, the IRB Panel(s), Institutional Official, or IRB Office staff may request a study undergo monitoring, often based on, but not limited to, the following criteria:

• Length of time since the last IRB submission
• Type of study

Routine Corrective and Preventative Action (CAPA) Plan Assessments

The Corrective and Preventative Action (CAPA) plan assessment is a post-approval monitoring activity consisting of a compliance review of CAPA plan adequacy, implementation, and adherence. An IRB Compliance Analyst begins the review based on information provided by the study team in a completed or acknowledged Reportable New Information (RNI) application. Monitoring consists of a self-assessment or direct (in-person or virtual) assessment of whether the proposed CAPA plan was 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 monitoring. The Compliance Team selects CAPA plans for monitoring at random; however, the IRB Panel(s), Institutional Official, or IRB Office staff may request that a specific plan undergo routine monitoring or directed review based on, but not limited to, the following criteria:

• Seriousness of the reportable event
• Feasibility of the proposed CAPA plan

Recruitment Materials and Processes Review

Routine post-approval monitoring may also occur for recruitment tools. Monitoring typically consists of the identification and an IRB Compliance Analyst-led of a recruitment tool. An IRB Compliance Analyst will ensure that the recruitment tool adheres to institutional guidelines for recruitment materials, the IRB-approved protocol, and that the IRB has approved the tool. The IRB Compliance analyst performs the review before notifying the investigator of their findings. All recruitment tools for research studies conducted at Northwestern or its affiliates, both on- and off-campus and online, are subject to monitoring.

The Compliance Team randomly selects recruitment tools for monitoring. Additionally, IRB Office staff may identify a recruitment tool to undergo review. Selection is based on, but not limited to, the following criteria:

• Randomly selected from posted materials in use and identified by the IRB compliance team, either directly or through reference
  • Inclusion of prohibited elements in an identified recruitment tool
  • Missing required elements in an identified recruitment tool

Overview of the Review Process

For all reviews, an eIRB+ auto-generated notification and letter will be sent via email to the Principal Investigator (PI) and primary study contact identified in the eIRB+ system to inform them that they were selected to undergo post-approval monitoring. The review will take place within the eIRB+ Compliance Workspace.

Study Self-Assessments and Study Status Assessments

The notification letter outlines the requirement that the PI review their study records within 30 days of initial notification and return their findings in the form of completed post-approval monitoring checklist(s) within the eIRB+ Compliance Workspace.

During post-approval monitoring, work with the Principal Investigator (PI) and their designee(s), if applicable, to assess research activities. The Compliance Team provides the post-approval monitoring checklists, which contain important elements from pertinent regulations, to assess research activities. The IRB Compliance Analyst will prepare observations, which may include areas of concern, required actions, and guidance in implementing corrective actions or best practice recommendations.

If the study identified for post-approval monitoring is ready to be closed with the IRB and the PI submits the study for closure in eIRB+, the PI must still engage in the post-approval monitoring activity and complete the assessment. The PAM activity will continue and may require follow-on actions until the PI receives the PAM closeout letter.

IRB Compliance Conducted Reviews (In-Person Visit or Virtual Review)

For in-person visits or virtual reviews, within the notification letter, the IRB Compliance Analyst will instruct the PI to review their study records and return their findings a week before the monitoring assessment. The notification letter will direct the PI to provide the following information:

• Access to study files and regulatory documentation (virtually or in-person)
• Access to participant records
• If the records are on paper to be reviewed in person, a quiet space in which to review study documents
• If any records are to be shared electronically, the PI should provide instructions on how to gain electronic access to systems if needed. The IRB can assist with setting up a secure way to share study documentation electronically.
• PI and study staff availability
• Proposed dates to schedule the monitoring assessment: at the start of the assessment and the end of the assessment

Corrective and Preventative Action (CAPA) Plan Assessments

For CAPA plan assessments, in the notification letter, the IRB Compliance Analyst will direct the PI to review their CAPA plan implementation within 30 days of initial notification and return their findings, with supporting documentation. The letter will also request the PI to provide the following information:

• PI and study staff availability
• Access to study files and regulatory documentation related to the CAPA plan (virtually or in-person)
• Access to participant records related to the CAPA plan (virtually or in-person)
• If the records are on paper to be reviewed in person, a quiet space in which to review study documents
• If any records are to be shared electronically, the PI should provide instructions on how to gain electronic access to systems if needed.  The IRB Compliance Analyst can assist with setting up a secure way to transfer study documentation electronically.
• Time to discuss with the PI or designated team member at the start of the assessment and the end of the assessment

Recruitment Reviews

The IRB Compliance Analyst will provide education and, if applicable, observations and next steps to address the recruitment review assessment.

Preparing For a Monitoring Assessment

An IRB Compliance Analyst will schedule the assessment with the PI and their designee. Once scheduled, the IRB Compliance Analyst provides the PI and designee with the PAM assessment checklists to complete to assess their study before the visit, as applicable.

The post-approval monitoring assessment evaluates areas such as, but not limited to, the following:

• 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 initial correspondence to the date of the monitoring assessment, the research team is encouraged to contact the Compliance Team with any questions or concerns related to the activity.

Completing a Monitoring Assessment

The IRB Compliance Analyst will communicate with the PI and designee throughout the PAM assessment within the eIRB+ Compliance Workspace. This includes observations, recommendations, and required actions. The IRB Compliance Analyst may schedule a follow-up meeting to discuss the observations with the PI and their designee(s). For any issues that may pose an immediate threat to research participants, the integrity of the data, or may constitute serious or continuing non-compliance, the IRB Compliance Analyst will notify the IRB Compliance, Education, and Communication Manager, if applicable, the Associate Director for IRB Compliance, Reliance, and Education.

If the monitoring assessment yields observations that require reporting to the IRB, the IRB Compliance Analyst will identify the information the PI must submit to the IRB for review and consideration, as well as the method (for example, creating a Reportable New Information (RNI) submission in eIRB+). The Compliance Team does not typically submit the full written PAM report or assessment correspondence to the IRB.

Upon completing the monitoring activity, the IRB Compliance Analyst will provide resources and education and will inform the PI and designee of any remaining required actions. Once any remaining actions are complete, the IRB Compliance Analyst will formally close out the post-approval monitoring activity and notify the PI.

Required Corrective Actions vs. Recommended Corrective Actions

Using the Post-Approval Monitoring Checklists as a Tool

The IRB Office recommends that, after you have assembled your files and folders, but before you start your study, you use the applicable post-approval monitoring (PAM) checklists to ensure your study files are compliant with applicable federal regulations, state laws, and institutional policy from the start.

Additional Information

For additional guidance, refer to the following SOPs, available on the SOPs webpage:

• HRP-028 – SOP Post-Approval Monitoring
• HRP-098 – SOP Corrective and Preventive Action (CAPA) Plan Assessments
• HRP-097 – SOP Post Approval Monitoring – Recruitment Materials and Process

You may also contact the Northwestern IRB Compliance Team at irbcompliance@northwestern.edu.