1. On-Site Reviews & Consultations

       A.  Random/not-for-cause monitoring

 i.    On-site reviews that are initiated by the QA/QI program.  The investigator is notified by email/letter and date is worked out that fits the    investigator/research staff schedule. 

Typically the outcome of the random audits are not shared with the IRB if only minor deficiencies in Human Research Protections are found and reporting methods are worked out between the QA/QI staff member and investigator/research team.  Minor deficiencies are those activities that do not impact subject safety, do not substantiate risks to subjects, or do not affect data integrity.  If the investigator does not report the minor deficiencies or take corrective action as specified in the audit summary report, the QA/QI staff member is obligated to report this information to the IRB.

Random monitoring findings that result in significant or serious deficiencies that place subjects at risk or can affect data integrity will require the QA/QI staff member to report the findings immediately to the IRB Chair.

                 ii.     Can be requested at study start-up within 1st year of IRB approval to ensure compliance with

institutional, state, and federal regulations.

                iii.     Brief meeting with and at conclusion of audit and will provide a report of observations and corrective


                iv.     Random sampling of research records with full review of regulatory binder.  Can take anywhere from

4 – 6 hours to complete.

         B.  For Cause Audit (at Request of IRB Institutional Official)

i.     For Cause reviews are initiated at the request of IRB Chair, the assistant director for research, or by the Board due to allegations or concerns about the conduct of the study which have been brought to the IRBs attention, submission paperwork which is inconsistent with what the IRB had approved, or deviations or adverse event reporting that may present significant risks to subjects, routine failure of the investigator to comply with federal and/or institutional requirements.

ii.    Full review of the regulatory files and all subject files, which may require two QA/QI staff members to complete.  These audits may take up to 6 hours or greater than one day to complete.

                   iii.   The Summary Report will be shared with the investigator and the IRB.

         C.  Investigator Requested Review

                  i.     At study start-up or anytime deemed appropriate by the Investigator/study team.

                 ii.     Prior to taking over as PI for a previously approved study.

2.  Consultations

         A.  Regulation Binder/Subject Research Chart Consultation

         B.  General Study Consultation

             1:1 meeting for study staff to ask questions specific to their protocol

         C.  Assistance with preparation for an External Audit Response

         D.  Assistance with creation of study team tools to facilitate documentation of research activities

         E.  Small Group QI In-Service

At the request of the investigator and/or study staff.  This service provides the study team with an opportunity to ask questions, discuss policies and address specific issues relating to the conduct of the research.  To schedule, please send an email to the IRB-01 listserv or refer to the IRB-01 staff directory for QA/QI Coordinator.