Post Approval Monitoring

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Potential Audit Questions

 

• 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?