Skip to main content

Post-Approval Monitoring & For-Cause Audits

The goal of the IRB Office’s compliance unit is to enhance the caliber of research performed at Northwestern University and to increase the effectiveness of the university’s Human Research Protection Program (HRPP) through education and compliance initiatives. One way in which the compliance unit meets this goal is through post-approval monitoring and/or directed reviews. The IRB compliance analysts perform the reviews to ensure the research complies with the federal regulations and institutional policies that govern research. During the activity, an IRB compliance analyst will assess research activities, identify area of concerns, provide guidance in implementing corrective actions, and prepare a report of the monitoring or directed review observations.

The compliance unit performs various post-approval monitoring and directed review activities primarily to ensure the rights and welfare of research participants are protected. The program aims to ensure research staff have the educational resources and guidance necessary to successfully conduct research and provide the research community the study support tools and other resources needed to perform compliant research.    

Post-Approval Monitoring:

Post-approval monitoring is a routine compliance review of the conduct of IRB approved studies that are meant to be educational to help improve research practices. An 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/or an observation of the consent process. All active studies, with the exception of those determined to qualify for exempt status, are subject to routine monitoring. The studies that are chosen for monitoring are primarily randomly selected; however, the IRB may request a study undergo review. Studies may be selected for review based on 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 than annual review by the IRB
  • Randomly selected from active studies in eIRB+

Routine Corrective and Preventative Action (CAPA) Plan Assessments:

CAPA plan assessments are a type of post-approval monitoring consisting of a routine compliance review of CAPA plan 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 typically consists of an in-person 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 CAPA plans that are chosen for monitoring are primarily randomly selected; however, the IRB may request a plan undergo directed review. CAPA plans may be selected for review based on the following criteria:

  • 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. The IRB compliance analyst will ensure adherence to institutional guidelines for recruitment materials, the IRB approved protocol, and that only IRB approved materials are used. All posted recruitment tools for Northwestern research studies, both on- and off-campus or online, are subject to routine monitoring. The recruitment tools that are chosen for monitoring are primarily randomly selected; however, IRB Office staff may identify a recruitment tool to undergo review if it appears to not adhere to our recruitment requirements. Recruitment tools may be selected for review based on the following criteria:

  • Missing required elements
  • Inclusion of prohibited elements
  • Prohibited recruitment strategy (such as general ads or flyers)
  • Randomly selected from posted materials

Directed Reviews (For-Cause Audits):

Directed reviews (for-cause audits) are not a routine compliance review and may be directed by the IRB, the Vice President for Research, Institutional Official or designee. A directed review may include but is not limited to a full study audit, a CAPA plan assessment, consent form observation, or evaluation of other research activities. The following may trigger a directed review:

  • Reportable new information that might affect the rights and welfare of research participants
  • Any review of materials submitted via eIRB+
  • An allegation of non-compliance (perceived or confirmed)
  • A suspension or termination of IRB approval
  • Participant and/or employee complaint
  • Whistleblower

Overview Of The Review Process:

Post-Approval Monitoring (Self-Assessment):

The IRB compliance analyst will contact the Principal Investigator (PI) and primary study contact via e-mail and inform them that they have been selected to undergo post-approval monitoring. The IRB compliance analyst will ask the PI to perform a review of 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.

Post-Approval Monitoring (In-Person Visit):

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

  • PI and/or 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/or their designee with a selection of days to choose from in order to schedule the visit. The compliance analyst will ask the PI to provide the following information when scheduling the activity:

  • PI and/or 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
Post-Approval Monitoring (Recruitment Review):

The IRB compliance analyst will contact the Principal Investigator (PI) and primary study contact via e-mail and inform them that a recruitment tool for their study was selected to undergo post approval monitoring.

Directed Review:

For directed reviews, the compliance analyst will ask the PI to provide the information requested above; however, on very rare occasions, the compliance analyst may not be able to schedule the visit prior to arriving on site.

Preparing For A Monitoring or Audit 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 so they may complete the forms and assess their study in advance of the visit, as applicable.

The review activity evaluates areas such as, but no 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
  • Privacy and confidentiality 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.

Closeout and Follow-Up Actions:

For remote post-approval monitoring (self-assessment and recruitment review), the IRB compliance analyst will communicate with the PI and study contact by email while reviewing their study. Upon completion of an in-person post-approval monitoring visit, CAPA assessment visit, or directed review, the compliance analyst will discuss the observations with the PI and/or their designee prior to leaving site. The PI will receive a written report that details the findings and observations made during the post-approval monitoring visit or directed review. The report may include recommended and/or required actions.  For either type of review, the compliance analyst will bring to the attention of the IRB compliance manager and/or executive director any issues that may pose an immediate threat to research participants or that may constitute serious non-compliance.

Post-Approval Monitoring:

If the monitoring assessment yields reportable findings 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 Northwestern IRB for review and consideration via eIRB+. Upon completion of the monitoring activity, the compliance analyst will inform the PI and/or designee of any remaining required actions.  If all actions are complete, the compliance analyst will formally closeout the post approval monitoring activity.  

Directed Review:

Following a directed review, the compliance analyst will route the findings and audit response to the convened IRB for their review and deliberation. The board will review the findings, make their determination and inform the investigator if additional actions are required. An IRB analyst will route additional actions to the research team following the convened review.   

Required Corrective Actions vs. Recommended Corrective Actions

Required Recommended

All actions must be addressed promptly to meet federal regulations, guidelines and IRB/NMH policies.

If the required action is not feasible, then justification should be provided.

Consider all recommended actions as they are strongly encouraged.

Decide the following that is best for you:

  • Accept Action
  • Postpone Action
  • Decline Action
  • Acknowledge

Additional Information:

Additional guidance can be found in:

You may also contact the Northwestern IRB compliance unit at irbcompliance@northwestern.edu.