Page 16 - Research Compliance Welcome Package

• The Responsible Party & Completion Date column should contain PI and/or applicable study staff names along with the corresponding completion date (or future due date if permitted).
• Please note, most corrective and preventive actions should be completed by the audit response due date. Actions that require more extensive resources or time (such as the development and implementation of long-term process changes) may be accepted with a specified future due date.
• If a finding requires an issue to be reported to the IRB, the submission reference number and the date of submission or approval should be provided.
Corrective and Preventive Action (CAPA):
• Corrective Action: This is the action taken to correct a problem or situation.
• Preventive Action: This is the action taken to prevent recurrence of a problem or situation.
• For the majority of audit findings, both corrective and preventive actions are necessary and required; however, there are some instances where only a corrective action or only a preventive action is needed.
• An appropriate CAPA is detailed, specific, and addresses the issue. A response of “Done” or “Completed” is not sufficient devoid of additional detail.
• Carefully read both the issue description and the Research Compliance Recommendation to ensure the CAPA is addressing all that it should.
• It is not uncommon for a proposed CAPA to either not address the specified issue or to address one aspect of the issue while overlooking other parts in need of response.
• If a response is not complete or is insufficient, it may be returned and additional detail requested.
• If you need help developing or tailoring CAPA for an issue, contact the Research Compliance Consultant(s) who conducted the audit. They know what should be addressed and can provide guidance on possible CAPAs.
Report Finalization:
• Once the staff response has been reviewed and approved, a Final Report will be issued.
• No further action is required by the staff unless a future CAPA due date has been permitted.
• There is an escalation plan in effect for failure to complete CAPA by the indicated future due date. A custom CAPA Implementation Summary will be provided to study staff when the final report is issued to avoid the need for escalation.
• Audit reports are an internal work product that should be stored separately from study records and not be shared without prior permission from the Research Compliance Office. If a sponsor somehow becomes aware of an internal audit and asks questions or requests a copy of the audit report, please contact the Research Compliance Office.
Example Issue
Corrective Action
Preventive Action
A protocol required activity was overlooked and not completed at a subject’s study visit.
Study staff notifies the sponsor and reports the issue to the IRB according to their reporting policy.
Study staff develops and begins using a checklist to ensure all protocol required activities are completed at each visit.
Research Compliance Office Contact Information
Please contact the Research Compliance Office with questions regarding responding to an audit.
Jennifer Gibbons-Ramirez Lindsey Estep
Stephanie Worley
Consultant
Consultant
Research Integrity Officer
(254) 215-9027 (254) 215-9028 (254) 215-9025
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10/29/18