Post-Approval Monitoring (PAM) Program November 17, 2015.

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Presentation transcript:

Post-Approval Monitoring (PAM) Program November 17, 2015

Why Was the PAM Program Created? To reduce risks to all engaged in human subjects research through prevention and education Meet conditions of FWA – ensure we comply with Common Rule Maintain AAHRPP Accreditation Accreditation demonstrates that UW has a high quality HRPP Clinical and Translational Sciences AWARD (CTSA) and other collaborations rely on this accreditation as do many other agreements To support multi-site research To remain in parity with our peer institutions who have similar programs 2

What Can be Selected for Monitoring? All non-exempt studies that have received approval from a UW- Madison IRB may be selected if they are open & active with a UW IRB. Studies with robust annual monitoring (VA, UWCCC, industry), or which are closed, or have not yet consented subjects are typically not eligible. Most PAM reviews are Routine (Random, QA) Reviews – selected from risk based pools, can occur only once every 12 months 3

What Does Monitoring Consist of? Pre-Visit Study is randomly selected and assigned to PAM who does a conflict check. PI & POCs in ARROW contacted by PAM to either confirm eligibility if unclear from the ARROW record, or to schedule visits. Initial Visit Q&A session – allowing PAM to learn more about the study, and study team to meet PAM and have their questions answered. Monitoring Visit PAM will review storage of study data, and will review study & subject records Verbal report of observations to study team. Final Report Study team will receive report of findings within 20 business days. IRB receives a copy of the report only if the IRB requested a directed review. Study team has 10 business days to provide a response if they disagree with findings. 4

What are Some Common Findings? Consent forms Unstamped form used Modifications without IRB approval Unapproved changes to study activities (without appropriate flexibility in protocol) Modified research tools or procedures (changes to study tools or subject population) Storage of study data in new mediums or locations 5

What Should I Do to Prepare for PAM? Review IRB approved applications (ARROW) to see if they match what is actually happening in practice. Submit changes of personnel or changes of protocol to keep studies up to date. Use the “Self-Assessment Tool” available on the PAM website to review the conduct of a study to see if it meets campus standards. Ensure proper training is in place (CITI, study specific), or tools are used (checklists) to ensure that all study staff understand how to properly conduct study activities. If you have any questions or aren’t sure if your practices are correct – contact the IRB or PAM Program – we are here to help! 6

Contact Information & Links to Resources Ryan Moze, JD Assistant Director Office of Research Policy Office of the Vice Chancellor for Research & Graduate Education 202 Bascom Hall Additional information available at: UW Madison HRPP website: PAM website (with link to Self-Assessment) Link to HRPP Policies Link to Campus Non-compliance Policy Link to the HS/MR IRB Reportable Events Guidance Link to the ED/SBS IRB website 7