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  • Version 1. 21.07.2011.

    Auditing SOP

    SOP Title Template SOP

    SOP No. SOP 12

    Author Julia Farmery

    Consulted Departments Lincolnshire Clinical Research Facility, Research and

    Development, Trust Consultants and research staff.

    Lead Manager Sign and Print Name

    Dr. Tanweer Ahmed Director of LCRF and

    Research and Development Manager

    Date published 21.07.2011

    Review date of SOP 21.07.2013

    Version 1

  • Version 1. 21.07.2011.

    1. Purpose:

    This SOP describes the audit procedure of United Lincolnshire Hospitals Trust. This SOP specifically describes the processes for selecting those studies for audit that fall under the Department of Health Research Governance Framework for Health and Social Care 2005 (2nd Edition) and/or the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments; the procedures for carrying out audits; and reporting audit results to Investigators. This SOP also describes the requirements for Investigators to respond to ULHT audit reports and implement corrective actions.

    As a host organisation under section 3.10 of the Research Governance Framework ULHT has a responsibility for auditing research practice and assuring adherence to current legislation and guidelines. As such, it is necessary to audit research for which ULHT is participating in; against the standards of the Research Governance Framework 2005 (2nd Edition), and the Medicines for Human Use (Clinical Trials) Regulations 2004 where applicable, and against the quality systems of Good Clinical Practice intrinsic to the Regulations.

    This guidance is to assist researchers in understanding the audit process, so that they are prepared should they volunteer or be selected for internal audit.

    The purpose of a research audit is to:

    Ensure participant and staff safety.

    Assist researchers with compliance to regulatory requirements.

    Improve research systems and data quality.

    Prepare researchers for external processes of regulatory inspection.

    Demonstrate robust research processes to external funders and industry.

    1.1 Audit requirement

    Under the Research Governance Framework, the Sponsor is responsible for the management and monitoring of a study. ULHT is responsible for auditing 10% of research projects on a yearly basis, as detailed in the Research Governance Framework for Health and Social Care 2005 (2nd Edition).

    Projects will be audited:

    On a voluntary basis.

    As a result of a risk graded assessment.

    If there is suspicion of non-compliance to regulation.

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    The yearly R&D reports, do not constitute audit and should be submitted for every study in addition to audit requirements.

    1.2 Role of the Auditor

    It is the auditors primary role to collect evidence of research practice and compare it against the requirements of Good Clinical Practice and Research Governance. The Auditor is responsible for documenting observations and conclusions, safeguarding audit documents, records and reports, assessing whether requirements are being met, and developing reports incorporating recommendations for change or adherence.

    2. Applies to: All individuals working with, alongside or participating in research activity.

    3. Relevant SOP documentation : Relevant to all hosted and sponsored studies conducted at ULHT

    4. Definitions : R&D Research and Development

    5. Policy: The UK Clinical Trial Regulations No. 1031, No. 2754, No. 2759, No. 1928, No. 2984, No. 941, No. 1164. Department of Health Research Governance Framework for Health and Social Care (2005) 2nd Edt. ICH, GCP Guideline, 1996.

    6. Procedure: Auditor Qualifications The Auditor should be independent to the research team to conduct audits appropriately. An auditor should be qualified by training and experience to conduct audits properly. An auditors qualifications should be documented (ICH GCP 5.19.2).

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    Audit Plan An audit plan will be developed by the Research Governance Manager and agreed with the researcher involved prior to beginning the audit. The plan should:

    Define the scope and objectives for audit.

    Provide timelines for audit conduct.

    Identify where and when the audit will take place.

    Identify requirements to be audited against.

    Identify groups and areas to be audited.

    List documents and records to be studied.

    List responsible people whose functions will be audited.

    Clarify who will get the final report and when it will be ready. Physical Audit Process This is the most intensive part of any audit process as it is the period where information is assessed and recorded. The process will start by the Research Governance Manager, explaining the scope and objectives of the audit, and how it will be carried out. Examples of audit techniques include:

    Interviewing researchers

    Reading documents

    Reviewing manuals

    Studying Records

    Reading reports

    Analysing data

    Observing activity

    Examining conditions

    Confirming interview evidence

    Documenting observations Audit Findings Once the practical audit has been completed the Research Governance Manager will develop a summary and make preliminary recommendations to assist with research conduct. The Research Governance Manager will:

    List any gaps in compliance with any supporting evidence.

    Cross-reference with regulatory requirements. Grading of findings Monitoring visit findings are graded using the following criteria: Major: A finding defined as one with the capacity to directly undermine the integrity of the entire study. For example findings:

    Where evidence exists that the safety, wellbeing, rights or confidentiality of study subjects has been (or has had significant potential to be) jeopardised.

    Where reason has been found to cast serious doubt upon the accuracy and/or credibility of study data.

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    Where approval for the study has not been sought from one or more regulatory agency/body or granted from one or more regulatory agency/body (e.g. Ethics committee, MHRA) but the study has commenced regardless.

    Where procedures not covered/included on the consent form are being performed or where new procedures have been introduced into the study protocol but where participants who had consented prior to their introduction have not been asked to re-consent.

    Where following study approval, significant amendments have been made to the study protocol or documentation but no new request for approval has been submitted.

    Moderate: A finding defined as one that compromises the integrity of a certain component(s) of the study, for example:

    Where there has been failure to comply with the regulatory requirements e.g. failure to assess and report SAEs and/or SUSARs accurately and to the correct bodies.

    Where there has been a significant unjustified departure from GCP e.g. failure to provide participants with a copy of their Consent Form or Participant Information Sheet.

    Minor: Any other inspection findings, defined as those where the integrity of the study is not directly compromised but which represent an absence of due diligence on behalf of study staff towards the conduct of the study. For example findings:

    Which demonstrate that no definite document management/organisation processes are in place at site / no investigator site file exists.

    Where there has been failure by study staff to inform the relevant authorities of amendments to start and stop dates or study specific documents.

    7. Responsibilities Audit Results Where there are many areas of improvement to develop, the Research Governance Manager will arrange a meeting with relevant research staff to discuss the recommendations or gaps in compliance. This can be used to develop solutions to any problems identified through the audit. Final Audit Report Over the following two four weeks from initial audit, the Research Governance Manager will review the gathered information and compile a final report. Which will be disseminated to the Principal Investigator and other relevant personnel specific to the audit. Finally the results and conclusions will be presented to the R&D committee, before being stored in the R&D department. The report will include:

    The detailed audit plan.

    A review of the evidence collected.

    A discussion of any conclusions drawn from the audit.

    A list of identified gaps in compliance.

    An assessment of how well regulatory requirements have been met.

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    Recommendations for change in practice to conform to regulation.

    A date for recommended review. Follow-up actions It is the Principal Investigators responsibility to ensure action is taken to correct any identified gaps in regulation compliance. If any advice or assistance is required the Research Governance Manager will be able to help with this. The Principal Investigator of the study is expected to respond to the audit report within 2 months and corrective actions made within a timely manner.

    References: Department of Health Research Governance Framework for Health and Social Care 2005 (2nd Edition). UK Clinical Trials (Medicines for Human Use) Regulations 2004; ICH, GCP Guidelines 1996. Please note, a large majority of this information and guidance has been taken from the Joint Research Office Audit SOP, Version 3. From Imperial College Healthcare and Imperial College London. Many thanks are given, with acknowledgeme

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