- To assure the rights and wellbeing of human subjects are protected
- To educate researchers about how to improve study conduct
- To assess research risk areas
- To provide resources to the Research Community
How Quality Improvement Works
Memo: The Investigator will receive an electronic memo indicating the intention for the review and requesting the Investigator select a time and place for the review to be conducted. The Investigator may assign a person to arrange access to the records and space for the review.
Onsite Review: The parameters that may be examined include, but are not limited to:
- Study File for required elements including: all versions of the approved protocol, consent forms and IRB approval documents.
- Subject eligibility
- Informed Consent Process Documentation
- Adherence to the protocol
- Data accuracy
- Adverse event / Unanticipated event reporting
- Confidentiality of records
- Data Safety Monitoring Plan
- Drug and Device handling and accountability (if applicable)
- Site specific SOP's (if applicable)
Exit Interview: Following study documentation review, the reviewer meets with the Investigator and any members of the study team (at the Investigator's discretion) to discuss the preliminary findings and provide the opportunity for immediate dialogue, feedback and/or clarification as well as process analysis, recommendations and education.
Review Findings: The Investigator receives the review findings electronically and is asked to provide feedback and a preventative action response for each finding within a defined time period.
Final Report: The Investigator's response is copied into the final report. Distribution is limited to the Investigator and others who may be responsible for action on findings and preventative action plans.