The goals of the IRB Office’s Compliance and Education Unit are to enhance the caliber of research performed at Northwestern and its affiliates and to increase the effectiveness of the Human Research Protection Program (HRPP) through oversight, education, and outreach. One way in which the Compliance and Education Unit meets these goals is through post-approval monitoring. During the evaluation, an 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.
The Compliance Team utilizes post-approval monitoring checklists (which contain important elements from pertinent regulations) to complete the evaluations. Study teams are encouraged to use post-approval monitoring checklists to conduct and document an internal compliance review anytime during the lifecycle of the research study. All post-approval monitoring checklists utilized by the compliance team are available to research teams and can be found on the IRBs Checklists and Worksheets page.
The Compliance Team performs various post-approval monitoring activities to protect research participants' rights and welfare. The Principal Investigator (PI) and their research personnel must fully 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.
Types of Monitoring Activities
Self-Assessments and IRB Compliance Conducted Reviews
Post-approval monitoring is a routine compliance review of IRB-approved studies. The review is an educational process that bolsters best research practices by providing guidance, resources, and educational support for conducting compliant human research. An IRB compliance analyst, who is internal to the IRB Office, performs the review. Monitoring typically consists of an investigator self-assessment or IRB compliance conducted review (in-person or virtual) of adherence to the IRB-approved protocol, assessment of study records and participant files, and evaluation of other research activities. The review may include or be limited to observing the consent process. All active non-exempt human research studies are subject to routine monitoring, including those where the Northwestern University IRB ceded IRB review to an external IRB. 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 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 IRB approval does not expire
- 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 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 expiration date (i.e., do not require continuing review).
An IRB compliance analyst performs the review based on the information provided by the study team in the completed self-assessment checklist, HRP-433 Studies Without an Expiration Date. Monitoring consists of a review of adherence to the IRB-approved protocol, assessment of study records, study status evaluation, document retention activities, and may include confirmation that the PI has submitted a continuing review application to close the study if the study meets closure criteria.
All active human research studies without an expiration date, including those where Northwestern University IRB 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
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 performs 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 internal review of a recruitment tool. An IRB compliance analyst will ensure that the recruitment tool adheres to institutional guidelines for recruitment materials, IRB-approved protocol, and that the IRB has approved the tool. 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 Unit randomly selects recruitment tools for monitoring; however, IRB Office staff may identify a recruitment tool to undergo review. Selection is based on the following criteria:
- Randomly selected from posted materials
- Inclusion of prohibited elements
- Prohibited recruitment strategy (such as general ads or flyers)
- Missing required elements
- Request to review recruitment materials
Overview of the Review Process
Post-Approval Monitoring (Self-Assessment)
An IRB compliance analyst will contact the Principal Investigator (PI) and primary study contact to inform them that their study was selected to undergo post-approval monitoring. The IRB compliance analyst will ask the PI to review their study records within 30 days of initial notification and return their findings, in the form of completed post-approval monitoring checklist(s), for review.
If the study identified for post-approval monitoring is ready to be closed with the IRB, the PI must still 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 IRB compliance analyst has sent the closeout notification.
Post-Approval Monitoring (In-Person Visit or Virtual Review)
For post-approval monitoring visits or virtual reviews, the IRB compliance analyst will provide the PI and their designee with dates to choose to schedule the monitoring assessment. The IRB compliance analyst will ask the PI to review their study records and return their findings a week before the monitoring assessment. The IRB compliance analyst will ask the PI to provide the following information when scheduling the activity:
- PI and study staff availability
- Access to study files and regulatory documentation
- Access to participant records
- Space in which to review study documents, where applicable
- Time to discuss with the PI or designated team member
Post-Approval Monitoring (CAPA Plan Assessment)
For CAPA plan assessment visits, the IRB compliance analyst will provide the PI and their designee with dates to choose to schedule the monitoring assessment. The IRB compliance analyst will ask the PI to provide the following information when scheduling the activity:
- 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.
Post-Approval Monitoring (Recruitment Review)
An 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.
Preparing For a Monitoring Assessment
The IRB compliance analyst schedules the assessment with the PI and their study contact, attempting to accommodate their schedules. Once scheduled, the IRB 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.
The review activity 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.
Closeout and Follow-Up Actions
For virtual post-approval monitoring, the 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 or CAPA assessment, the compliance analyst may discuss the observations with the PI and their designee(s) 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 IRB compliance analyst will notify the IRB compliance manager and, if applicable, the associate director for IRB compliance and education on any issues that may pose an immediate threat to research participants, the integrity of the data, or constitute serious or continuing non-compliance.
If the monitoring assessment yields reportable observations that require reporting to the IRB, the correspondence from the compliance analyst will detail the information the PI must submit to the IRB(s) for review and consideration via eIRB+. The Compliance Team does not typically submit the full written report or assessment correspondence to the IRB, but does retain them in alignment with Post-Approval Monitoring Assessment (HRP-028). Upon completing the monitoring activity, the IRB compliance analyst will inform the PI and designee of any remaining required actions. The compliance analyst will formally close out the post-approval monitoring activity and notify the PI if all actions are complete.
Required Corrective Actions vs. Recommended Corrective Actions
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 email@example.com.