- 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 PI will receive a memo indicating the intention for the review and requesting that the PI select a time and place for the review to be conducted. 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 the review of study documentation, the reviewer meets with the PI and any members of the study team (at the PI'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.
Draft observations: The PI receives the draft observations electronically and is asked to provide feedback and a preventative action response for each observation within a defined time period.
Final Report: The PI's response is copied into the final report and distribution is limited to the PI and others who may be responsible for action on observations.