RIRA - Post-approval Monitoring Process

• What is Post-approval Monitoring (PAM)?

  Post Approval Monitoring is a process that helps UTMB and its researchers comply with UTMB, state, federal and sponsor regulations. The post approval monitoring process helps to ensure that approved IRB protocols are substantively executed as approved.

• What is the process?

  15-minute check in

  • Provides the PI the opportunity to share status information about the IRB-approved protocol.
  • Allows RIRA to learn if enrollment or data collection has begun.
  • Informs how whether the document examination will be virtual or in-person.

    Document examination

  • Review study documents to confirm alignment with the IRB approved protocol.
  • Encourages the PI/study team to ask monitoring-specific questions and concerns.
  • Allows RIRA to respond to PI/study team questions and address concerns.

  Interactive feedback – everyone has questions on a research journey

  • A researcher may have questions
  • A study coordinator may have questions
  • RIRA may have questions
  • We won’t know until we ask
• Why was my project selected?

  Receiving notification that a project will be monitored by RIRA simply means that you have an active project open with the IRB. Monitoring does not imply that wrongdoing has occurred or is suspected in the conduct of the study. It is a routing process.

• Will RIRA’s document inspection meeting be held virtually or in-person?

  Virtual meeting

              If all consenting, document collection, and storage are obtained/stored electronically then the document inspection meeting could be completed virtually.

  In-person meeting

              If any consenting, document collection, and storage are obtained/stored by paper then the document inspection meeting could be completed in-person and sometimes hybrid.

• How often will my project documents be examined?

  Frequency of monitoring visits depends on the study design. The more complex the design the more involved RIRA will be for example, RIRA will most likely contact study teams engaged in investigator initiated clinical trials more often than a study that is not utilizing the informed consent process.

• What should I do to prepare for RIRA’s document inspection?
  • Have all study documents available for the monitor.
  • Reserve a suitable meeting space where documents can be privately examined, where conversations can be confidential, and that is easily accessible for the PI.
• Who should be present during RIRA’s document inspection?

  The preferred option would be to meet at a mutually agreeable time for both the RIRA monitor(s) and the PI and necessary staff for the first 15-minuts of a study visit. This allows us time for any questions to be responded to up front. The PI is not able to attend, the PI may designate a representative for the PAM review. (Study staff are not required to stay with the monitor but can remain if they wish to do so).

• What will happen during RIRA’s document inspection meeting?

  The PI or designated representative will meet for the first 15-minutes with the monitor to discuss any initial concerns. If there are no concerns, the monitor may be left alone to review the study documents. 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 happens after the RIRA’s document inspection meeting?

  RIRA will provide a summary of the visit within 7 business days of the inspection meeting.

• What are some of the benefits that an investigator may gain from the PAM?
  • Increase confidence that their research complies with university, state, federal, and sponsor regulations.
  • Assures the PI/study team that RIRA is a resource and a support system that is available to the research community.
  • Provides the assistance to PI/study teams, especially those that are new to research, to address questions and concerns that will allow them to complete their projects successfully.
  • Assist in cultivating a research environment in which faculty research can thrive.
• Who do I contact if I have additional questions after the PAM meeting?

  For RIRA specific questions please reach out to Karen Jarvis-Thorne.

  For IRB specific questions please reach out to Anne Clarke.