Principal Investigator Audit Response Form

Principal Investigator Audit Response Form – Instructions

The contents of the Principal Investigator (PI) Audit Response Form are CONFIDENTIAL to the University of Miami. Copies may be made ONLY for the purposes of responding to findings or for information within the university. This report must not be archived with other study documents.

Audit findings made by the Office of Research Compliance Assessment (ORCA) are categorized as: a) high significance; b) medium significance; and c) low significance for the purpose of advising the appropriate governing board/committee (GB/C) includes: IRB, ESCRO, IACUC, IBC, etc. as applicable.

If an ORCA audit report contains findings that are recommended to the GB/C as being of high or medium significance, the PI must submit to ORCA a completed PI Audit Response Form within 5 days of receipt of the ORCA Audit Report. Failure to do so shall be reported to the GB/C and may be considered by the GB/C to be non-compliance. Responses to Low significant findings are encouraged but not required. Audit reports and PI responses shall be forwarded to the GB/C for its review and determination.

The PI’s response(s) to audit findings may either an appeal of the findings and/or the significance categorization by ORCA or a description of corrective and preventative actions. To assist PIs in presenting corrective and preventative actions, the following template is recommended. The PI response should be emailed to the ORCA Compliance Officer assigned to the associated audit. Further assistance and guidance regarding the completion of a response to an audit, is available from ORCA at 305-243-4538.

Investigator: / Copy-n-Paste the ORCA Audit Report
Department: / Copy-n-Paste the ORCA Audit Report
Protocol #: / Copy-n-Paste the ORCA Audit Report
Protocol Title: / Copy-n-Paste the ORCA Audit Report
Audit Date: / Copy-n-Paste the ORCA Audit Report
Audit Finding #: / The # from the ORCA Audit 1.1.1, 1.1.2, 2.3.1 etc.
Finding: / Copy-n-Paste the ORCA Audit “Finding” field
Significance: / Copy-n-Paste the ORCA Audit “Significance” field
Corrective Action (CA): / What actions are required to correct the defect/deviation? Be as specific as possible with quantifiable actions that can be verified. Failure to be specific and address the root cause of the finding may result in the governing board/committee requiring further details. Make sure to address ORCA’s “recommendations” in this section.
CA Assigned to: / The person responsible for implementing CA
CA Due Date: / The date the CA will be complete (in instances where the CA is already complete, input the actual completion date). The governing board/committee may change this date at their discretion.
Preventative Action (PA): / What (if any) preventative actions are being implemented to ensure repeat violations/deviations are eliminated. Again, be specific as to what actions are being taken. They should be tied to root cause of the finding and include follow-up actions to ensure continued compliance. If none are required, enter NONE.
PA Assigned to: / The person responsible for implementing PA. If none are required, enter NONE.
PA Due Date: / The date the PA will be complete (in instances where the CA is already complete, input the actual completion date). The governing board/committee may change this date at their discretion. If none are required, enter NONE.

Copy and paste the finding response template as many times as required to respond to all required findings.
Protocol Information:

Investigator:
Department:
Protocol #:
Protocol Title:
Audit Date:

Finding Responses:

Audit Finding #:
Finding:
Significance:
Corrective Action (CA):
CA Assigned to:
CA Due Date:
Preventative Action (PA):
PA Assigned to:
PA Due Date:
Audit Finding #:
Finding:
Significance:
Corrective Action (CA):
CA Assigned to:
CA Due Date:
Preventative Action (PA):
PA Assigned to:
PA Due Date:
Audit Finding #:
Finding:
Significance:
Corrective Action (CA):
CA Assigned to:
CA Due Date:
Preventative Action (PA):
PA Assigned to:
PA Due Date:

Principal Investigator Name:

Principal Investigator Signature:

Date:

The contents of the PI Audit Response Form are CONFIDENTIAL to the University of Miami. Copies may be made ONLY for the purposes of responding to findings or for information within the university. This report must not be archived with other study documents.

Version: 8-25-10