Page 16 - Research Compliance Welcome Package (1.4.19)

How to Respond to an Internal Research Compliance Audit
Research Compliance Tip Sheet
General Considerations:
• Finalized audit reports are viewed by management and above as well as various institutional committees. As such, the response to an audit report should be well-written and professional.
• Not everyone who sees a finalized audit report will be familiar with the study or the audit. Responses should be brief but contain enough detail to be clear without the need for additional explanation.
• One goal of the Research Compliance program is to assist in the conduct of high quality research at BSWH. An audit, even one that is for-cause, is intended to be constructive and educational rather than punitive.
• If ever something is unclear or confusing, Research Compliance Office staff are available to answer questions and provide guidance.
Reading a Draft Report:
• An audit report is made up of five sections:
• Distribution and Contacts - indicates who will receive the final report and provides Research
Compliance staff contact information.
• Executive Summary and Results - provides background information and a snap shot of the audit findings. Any urgent or high-risk findings are briefly described here.
• Audit Details - provides details regarding the timing, scope, and procedures of the audit.
• Risk Definition and Classification Process - contains an explanation of the risk classification and
may be used as a reference for understanding the perceived risk of the findings.
• Findings Table - contains a detailed explanation of the audit findings, recommendations from Research Compliance on actions to take, and space for study staff to provide corrective and preventive actions.
Responding to a Draft Report: Response Timeframe:
• A typewritten response is required two weeks from the date a draft report is issued. This is especially
important if the report contains urgent or high-risk findings or any issues that require reporting to others.
• There is an escalation plan in effect for failure to respond to an audit. A custom response calendar will be provided to study staff when the draft report is issued to avoid the need for escalation.
• If study staff anticipates an inability to complete a response by the deadline, the Research Compliance Office should be contacted immediately.
Response Content:
• The Research Compliance Recommendation for a given issue generally contains multiple parts which are numbered for clarity and correspond
with a numbered Corrective/Preventive
Action (CAPA) and Date field.
• If the Research Compliance Recommendation contains multiple parts, be sure to address every aspect of the recommendation in the written response.
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