Post Approval Monitoring

The goal of post-approval monitoring of studies involving human subject research is to confirm by observation and documentation comparison, an accurate and consistent protocol performance, conducted in accordance with an Institutional Review Board (IRB)-approved protocol. An additional goal of the program is to provide education to the investigators on best practices for conducting their human subject research study in compliance with their IRB-approved protocol, Tulane University (TU) IRB policies and guidance, and federal regulations. The program is also designed to help investigators, their teams, and the University prepare for external audits by granting, regulatory, and accreditation agencies.

Perhaps the most effective way to prepare for a PAM visit is to carefully and objectively read your approved protocol and make sure that you and your staff are performing the research activities as described and approved by the IRB. Many variables can play into the need for adjustment in the design, procedures, etc., of your protocol. The main thing to remember is any changes to the IRB-approved protocol must be approved by the IRB prior to implementation. It is easy to be caught up in the progress of research and forget to submit an amendment. Likewise, an issue may seem trivial to a researcher, but it may be of great concern to the IRB, federal regulators, or auditors.

The staff of the HRPO is always willing to assist in answering questions or to help facilitate modifications to your protocol. They can be reached at 504-988-2665 or irbmain@tulane.edu if you have any questions prior to submitting your amendment.

Investigator Self-Assessment Checklist

• How many participants are currently enrolled in the study? Is the number enrolled in line with the number approved? Is a modification to add participants needed?
• Are key personnel performing duties as described and approved? Are modifications needed?
• Have there been early withdrawals from the study? Have they been reported during continuing review?
• Have there been any adverse events resulting in unanticipated problems? Were they reported?
• Who is responsible for conducting study procedures? Are procedures in accordance with what was approved by the IRB?
• Have any changes been made to the approved materials (recruitment fliers, questionnaires, interview questions, etc.)? Has IRB approval been sought prior to implementing these changes?
• Who is responsible for training study personnel? Are records of training maintained?
• Are all research team members who have contact with participants or the participants’ data listed as Key Personnel on the IRB-approved protocol? Is a personnel amendment needed?
• Is there a copy of the IRB-approved protocol on file? Including any continuing reviews and amendments? Are all personnel (i.e., PIs, co-Is, research staff) aware of all approved modifications?
• Do you have a copy of the approval letter on file?
• Is the current version of the informed consent document being used? Does it have the IRB stamp?
• Are waivers of documentation of consent in place for non-exempt on-line studies?
• Are you using the IRB approved advertisements?
• Are study documents (i.e., applications for approval, approval letters, informed consent) maintained for 3 years?
• Are documents stored as outlined in the IRB-approved protocol?
• ORR strongly recommends creating a file for each participant containing all study documents (i.e., consent, surveys, debriefings, etc.) when applicable.

Below are examples of common findings from post-approval monitoring visits:

• The informed consent document on file is not complete (i.e., only the page containing the signature is on file).
• The IRB-approved version of the informed consent or assent document is not used.
• Dates:
  • Informed consents are not dated by participants or those obtaining consent (in real time).
  • Dates are added in by persons other than those giving or obtaining consent.
  • Dates of consent occur after study procedures have begun.
  • Dates of consent occur prior to receiving IRB approval of study
• Signature problems:
  • No real time signatures by individuals obtaining consent (missing, or postdated).
  • Signatures are illegible; this is particularly important when determining if individual giving consent for minors is authorized to do so (i.e., parent or legal guardian, not a grandma, uncle, aunt, sibling, etc.) Again, ORR recommends “Printed Name” lines in informed consent documents.
• Changes have been made to the IRB-approved survey questions or interview questions:
  • Questions have been added prior to IRB review or approval.
  • Questions have been removed prior to IRB review or approval.
• Recruitment methods have been changed prior to IRB review or approval.
• Survey methods have changed (e.g., from paper versions to online versions).
• Compensation:
  • Logs are not kept of human subject compensation.
  • Compensation amount differs from that stated in the IRB.
  • Subjects who signed compensation logs are not the same as those consented.
• Study records:
  • Study records are not STORED as indicated (i.e., storing other than removal for working on them, stored unsecured).
  • Persons reviewing study records who are not approved or trained to do so.
• Personnel are not CITI trained nor do they have accurate knowledge of approve protocol.

If you have identified discrepancies between your current practices and those outlined in the approved protocol, please make the appropriate corrections. This may require submitting an amendment to your protocol or simply implementing better documentation practices.

Remember, the goal of post approval monitoring is not to “catch” you doing something you aren’t supposed to be doing. Rather, it is designed to facilitate research by making sure it is conducted in a manner where the conditions of federal regulations and University policy are met and by assisting researchers to identify and correct any deficiencies.

• What is Post Approval Monitoring?
  • Post Approval Monitoring is an examination of the research facility and study documents to assure that human subjects are protected, and the investigator is in compliance with applicable University and Federal regulations. Conducting post approval monitoring will help to ensure that appropriate applications and supporting documents are executed as approved, any changes or adverse events are reported, and the consent forms are approved. 
• What are some of the benefits that an investigator may gain from the PAM process?
  • Some of the possible benefits that may be gained from a review include but are not limited to: 
    • Increased understanding of the regulations that guide all of our research projects
    • Increased communication concerning updates to Federal and University regulations
    • Access to resources and individuals to clarify the Federal and University regulations
• How are the research protocols selected?
  • All non-exempt studies that have received approval from a TU IRB may be randomly selected for a routine monitoring visit as long as they are open and active.
• How often will routine monitoring occur?
  • An individual PI may be selected for routine monitoring once every 12 months.  For Example: PI Smith is PI on three studies (A,B,C). Study A has a routine monitoring visit occur. Now, neither studies A, B, or C can be selected for routine visits in the following 12 months.
• What happens once a study is selected for a monitoring visit?
  • The study team will receive notification from a monitor that their study has been selected for monitoring. An initial visit will be scheduled. At this initial visit, the monitor will describe the monitoring process and discuss the study with the study team. The study team will also have the opportunity to ask questions ahead of the actual monitoring visit.
• How long will the assessment take?
  • If your documents are complete and organized, the review will take about one hour.  If an investigator is not prepared, the review may take several hours. 
• How should study teams prepare for the monitoring visit?
  • When the visit is scheduled, the monitor will provide the study team with a self-assessment tool via email. This self-assessment tool will closely mirror the evaluation tool used during the monitoring visit. Study teams should ensure their study records and materials are present and organized, and that they have any preliminary questions answered prior to the monitoring visit.
• What will happened during a monitoring visit?
  • The study team will have received a letter via email before this visit outlining what will occur. The monitor will arrive as scheduled and will spend time reviewing study records and materials. Study teams are encouraged to ask questions throughout the visit. At the end of the visit, the monitor will meet with study team members to briefly discuss the visit and ensure any study team questions are answered.
• What Results can study teams expect from the monitoring visit?
  • Study teams will receive a follow-up letter within 20 business days of the monitoring visit. This letter will provide study teams with an overview of the findings of the visit and any potential follow-up actions that may be needed.
• What if a study already has research monitoring?
  • Post-approval monitoring selection letters ask whether there is existing monitoring and if so what this monitoring consists of. If the post-approval monitoring team determines that a study has robust monitoring, it will be exempt from routine review and the monitoring visit letters will be accepted unless there are significant findings. The post-approval monitoring team will generally determine monitoring to be robust when: 1) it is conducted annually, 2) by an individual/individuals that are not part of the study team, and 3) addresses the same areas covered in the Post Approval Monitoring Self-Assessment Tool.
• What if the PI is unable to attend the scheduled PAM meeting?
  • The preferred option would be to meet at a mutually agreeable time for both the PAM reviewer(s) and the PI and necessary staff. If the PI is not able to attend, the PI may designate a representative for the PAM review. 
• Are the post-approval monitors authorized to view my research records?
  • Section IV of the Compliance Monitoring and Quality Improvement policy describes the various research compliance mechanisms across campus which includes Office of Research Compliance staff.
• Are there other ways the PAM program can assist in improving the conduct of my research?
  • The PAM Program offers several service meant to assist researchers across campus. These services include in-person training sessions, fall and spring drop-in Q&A sessions, and pre-enrollment consultations.  More information on these services can be found here.

The Common Rule 17 Signatory agencies, including DHHS, FDA and DoD

Human Subjects Research:

• 45 CFR 46
• 21 CFR 56
• 32 CFR 219

Additional FDA regulations:

• 21 CFR 312 (drug)
• 21 CFR 812 (device)

U.S. Department of Health and Human Services (HHS)

Office for Human Research Protection (OHRP)

Terms of the Federalwide Assurance (FWA)