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GCP audit checklist

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Clinical Audit Checklist (GCP)
Preparation, Planning & Selecting the Standards/Criteria
Does the clinical audit have a clearly-stated quality improvement aim and objectives?
Does the audit measure performance against standards for process and outcomes that are based on the best available evidence?
Are the standards clearly referenced?
Has a named clinician been identified to lead the clinical audit?
Is the named lead is a junior doctor working on rotation?
Has a more senior clinician been nominated to oversee the project and ensure that it is completed and that the quality improvement aims are met?
Is the audit to be undertaken in compliance with local governance arrangements?
Is it proposed and registered in accordance with local policy and protocols?
Are the sample identification, data collection and analysis, and all other aspects of the clinical audit cycle compliant with the law and best practice on information governance and data security
Are all members of the clinical audit committee engaged in the clinical audit cycle from the start and in delivering the service to be audited?
Is a stakeholder group identified and engaged in the clinical audit?
Does this group include representatives of the clinical audit committee, other clinicians whose practice may be impacted by the findings of the audit, service managers responsible for the service to be audited, relevant service users, carers and lay representatives, and where appropriate, senior clinicians and managers, board members, commissioners, and others?
Are any ethical or information governance concerns identified?
Are they escalated to the appropriate clinical lead and acted on in accordance with best practice?
Did the stakeholder group sign off the audit aim, objectives, standards and audit method before data collection began?
Was data collection undertaken on the authorization of the senior clinician leading the project?
Measuring Performance
Is the data set collected defined with reference to the audit standards?
Is the population of patients to be included in the audit defined with reference to the audit standards?
Is the audit sample size set, and the sample selected, in accordance with best practice guidance?
Is the rationale behind the sample size and selection method documented in the audit report?
Is any part of the data to be extracted from electronic health records?
Is the data extraction tested to ensure that the correct data source was being used, and the correct sample and data were being extracted?
Is any part of the data to be collected from paper health records?
Is an existing validated data collection tool used?
Is a data collection tool designed and piloted and the results from the piloting process reviewed before full-scale data collection began?
Are data collectors appropriately qualified and trained?
Is a protocol for data collection developed and piloted alongside the data collection tool?
Is clinical audit data analyzed using appropriate statistical techniques to measure compliance with audit standards?
Are the findings presented in a way which gave a clearest possible picture of performance?
Are the clinical audit findings reported with the appropriate level of granularity?
Are full details of the clinical audit method documented to ensure that any necessary repeat data collection to measure the impact of interventions was carried out in exactly the same way?
In the final report, are any unavoidable variations in the repeat data collection method documented and reported alongside the results?
Implementing Changes
Are the results shared with the stakeholder group?
Do the findings show compliance with standards?
Are steps undertaken to establish the underlying causes for non-compliance?
Is an action plan developed to address the established underlying causes?
Is the action plan signed off by the stakeholder group and in accordance with local governance arrangements?
Is the action plan implemented?
Is the impact of the implementation of the action plan monitored in an appropriate way?
Are any unforeseen negative impacts identified?
Are steps taken to address them?
Has evidence been obtained to demonstrate that implementation of the action plan has resulted in an improvement in the quality of services?
Sustaining Improvements
Has the stakeholder group determined whether the audit needs to be repeated?
Has the stakeholder group determined whether refinements are required to the audit protocol and data collection tool for greater focus on shortfalls identified?
Have alternative approaches to ensuring that quality of service is maintained, such as some form of ongoing monitoring, been considered?
Have the results of the audit been documented and shared with key stakeholders, service users, the rest of the organization, and with the public?
Have learnings from the audit been shared with colleagues, both within the organization and across partner organizations, including commissioners, clinical networks and other professional groups?
Sign Off
Additional Recommendations
Audit Lead Name & Signature
Name, Department & Signature
Name & Signature
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Please note that this checklist template is a hypothetical appuses-hero example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.
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