806: Elements of External Review

Reviews may include, but are not limited to the following activities: 

  • Interviews of the principal investigator, co-investigators and/or research staff

     

  • Review of randomly selected participant files to:
    • Determine whether the approved inclusion/exclusion criteria were met
    • Determine that participants were not enrolled until after all appropriate approvals were obtained
    • Determine whether the correct informed consent document(s) was utilized and that informed consent was obtained in the manner approved by the IRB
    • Determine whether the approved dose ranges of the study drug were administered

 

  •  Review of study files to:
    • Determine whether all of the amendments were reported before changes were implemented unless it was necessary to eliminate apparent immediate hazard
    • Determine whether adverse events and unanticipated problems were reported in a timely manner
    • Determine if the advertisements and other recruiting materials in use are the versions approved by the IRB
    • Determine whether the informed consent document complies with federal regulations
    • Determine whether IRB (RIO) and VA R&D administrative file(s) contain all modifications and adverse events submitted by the investigator
    • Determine whether IRB review was timely
    • Review projects to verify from sources other than the researcher that no unapproved changes have occurred since previous review
    • Monitor conflict of interest concerns to assure the consent documents include the appropriate information and disclosures
    • Determine if continuing reviews were completed within one year (or more often if appropriate)
    • Observe the consent process as determined necessary by the convened IRB (i.e. considered when a complaint is received regarding the informed consent process, or when investigator veracity is doubted)
    • Conduct any other monitoring or review activities as deemed appropriate by the IRBs
    • Confirm completion of compliance education for PI and research staff
    • Compare list of subjects (# enrolled/accrued) provided by the Investigator with continuation review report for consistency

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