a summary of the findings/recommendations to the PI. In some cases, a follow-up assessment and/or training session(s) may be required. If serious and/or continuing noncompliance is found, the CQI report will be submitted to the IRB Chair and/or the IRB for determination. The IRB will make recommendations to correct any issues of serious and/or continuing noncompliance. See the “Serious and Continuing Noncompliance” policy (Chapter 21) for more information. Quality Assessments include the following activities:
Interviews with the PI/research team to assess their knowledge of the study procedures.
Obtaining feedback from researchers on the IRB process
Inspection of subjects meeting inclusion criteria
Records inspection and storage facilities
Inspecting documents and coding mechanisms used to protect confidentiality
Review of adverse events and unanticipated problems documents
Inspection of PI and researcher CVs and education certificates (Human Subjects, HIPAA, as applicable).
Inspection of payment logs
In addition to quality assessments, the OPRS staff conducts internal IRB assessments to measure compliance.
IRB Assessment Process The OPRS staff conducts ongoing internal IRB assessments as needed to measure compliance in IRB documentation. Assessment of IRB documentation includes:
Review of IRB minutes and full board meeting agendas, paying particular attention to subject complaints, adverse events, and ad hoc agenda items (e.g. miscellaneous problems/issues/suspensions/audits/ etc.)
Chapter 20: Continuous Quality Improvement USC HSPP Policies and Procedures
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