Page 17 - Research Compliance Welcome Package (1.4.19)

• Blue text prompts are included to aid the study team in responding to each required field.
• Audit reports are reviewed prior to finalization and may be returned if all findings are not adequately
addressed.
• 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.
• The Responsible Party & Completion Date column should contain name(s) of staff responsible for
correcting the issue and/or preventing it in the future, along with the corresponding completion date(s). This could include key study personnel listed on the project or staff from other areas like clinic personnel, when appropriate.
• 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.
• The planned preventive and corrective action must still be indicated in instances where a future date is used.
• Please note, future due dates must be approved by the Research Compliance Office. Use of future due dates without approval may result in an audit report being returned for correction.
• It is the expectation that all issues be resolved by their specified future due date. Research Compliance will track CAPA with future due dates and will follow up with staff to verify completion or escalate delays as necessary.
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.
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.
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