Quality Assurance

YCCI Quality Assurance Specialists are available to consult with investigators, upon request, on quality-related issues and protocol compliance, provide their expertise to confirm study conduct is according to Federal regulations, ICH GCP guidelines, university policies and all other applicable regulations, and provide feedback and suggestions on best practices.

For regulatory agency inspections, the YCCI QA team is available to support investigators in the preparation of study documents and notification to Yale leadership and applicable ancillary groups. The team may also act as a liaison between the inspector and the PI/study team during the course of the inspections.

If notified of a regulatory agency inspection, such as FDA or EMA, please contact the YCCI Senior Associate Director of Quality Assurance, immediately: Nancy S. Shelton, M.B.E.C., CCRP, CHRC.

Further details about the inspections are provided under Regulatory Agency Inspection (FDA, EMA, etc.)

YCCI QA Specialists conduct internal reviews, in partnership with the Yale Human Subjects Protection Program (HRPP), using risk-based stratification methods.

Internal reviews generally involve the following steps:

1. Audit Notification/Notice of Intent to Review is sent to the PI
2. Introductory Meeting is held with the PI, study coordinator, YCCI QA Specialist, and HRPP representative (as applicable)
3. Study Record Review is conducted by the YCCI QA Specialist (regulatory, study subject, drug/device, research specimen, and IND/IDE records, as applicable)
4. Exit Interview is held with the PI, study coordinator, YCCI QA Specialist, and HRPP representative (as applicable) to discuss observations
5. Final Summary including any identified Action Items is sent to the PI
6. Response to the Action Items is provided by the PI

YCCI QA Specialists are available to conduct preparatory reviews upon investigator/study team request. These reviews are typically requested if the investigator is notified of a routine sponsor Good Clinical Practice (GCP) audit, or if the investigator is approached by a sponsor requesting to conduct a pre-inspection visit, which generally occur once the sponsor submits a marketing application to a regulatory agency. The YCCI QA Specialists may assist the investigators with a review of study documents to identify and correct deficiencies prior to these visits and may assist with addressing any concerns with the sponsor.

To request a preparatory review, please contact the YCCI Senior Associate Director of Quality Assurance, promptly upon notification of a planned sponsor audit: Nancy S. Shelton, M.B.E.C., CCRP, CHRC.

The YCCI QA team is available to support investigators who have been notified of a regulatory agency inspection.

If you are contacted by a sponsor or regulatory agency notifying you of an imminent inspection, please contact the YCCI Senior Associate Director of Quality Assurance, immediately: Nancy S. Shelton, M.B.E.C., CCRP, CHRC.

Additionally, contact the Yale HRPP, the IRB of record and the study sponsor informing them of the inspection notice.

• Confirm that the study sponsor has the most up-to-date contact information for the principal investigator (PI) listed on the FDA 1572 or Statement of Investigator.
• Note down the full name and the contact information (phone number and email) for the agency inspector.
• Begin confirming that all study documents – paper and/or electronic – are available, complete, and organized.
• Plan to adjust the PI’s schedule to be available to meet periodically with the inspector – typically for an introductory meeting, agreed upon intermittent times, and at the exit meeting.

• FDA
• EMA
• Health Canada
• PMDA

The YCCI QA team is available to review agency inspection, external audit, and monitoring report findings and to conduct a Root Cause Analysis (RCA) in order to methodically identify the root causes of findings, so that they may be addressed.

The YCCI QA team will also be available to the investigator in developing a Corrective and Preventive Action (CAPA) plan to ensure corrective actions and preventative improvements to the processes that can be taken to eliminate causes of non-compliance.

To request a RCA or support with CAPA development, please contact the YCCI Senior Associate Director of Quality Assurance: Nancy S. Shelton, M.B.E.C., CCRP, CHRC.

Several guidance documents, study tools and templates are available to aid research teams with documenting required regulatory and protocol information, tracking study procedures and organizing study documents.

Go to the Resources and Documents section of the website to view.
Be sure to click on each subheading to review the available documents.