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Study Management & Closure: Audit

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Introduction

Funders, sponsors and NHS / University Research and Development offices may wish to conduct an audit of your study, in order to fulfill their responsibilities under the Research Governance Frameworks.  The extent, scope and frequency of audits will vary between organisations, and should be determined by the risks the study is believed to pose to the organisation.  Possible elements of an audit could include:  adherence to protocol and other study documentation, evidence of monitoring and/or reporting, recruitment and consent procedures, quality assurance of data which may possibly involve source data verification.

Clinical trials of an Investigational Medicinal Product (IMP), and other studies Regulated by a competent authority, may also be subject to Inspection (i.e. audit conducted by a competent authority).

Resources

  • 1. NHS R&D Forum: Research Governance Monitoring and Audit

    A document produced Research Governance Working Group of the NHS R&D Forum that describes how NHS organisations across the UK conduct research governance audits and makes recommendations of good practice.

    Good Practice for some em studies (not applicable for all) Date added: 23 October 2008
  • 2. CT Tool Kit: Audit

    The NIHR Clinical Trials Tool Kit is designed to support clinical trialists and regulators in ensuring clinical trials of investigational medicinal products are conducted in accordance with the Medicines for Human Use (Clinical Trials) Regulations: including risk based monitoring of clinical trials of IMPs.

    Legal Requirement for some em studies (not applicable for all) Date added: 23 October 2008
  • 3. CT Tool Kit: Inspection

    The NIHR Clinical Trials Tool Kit is designed to support clinical trialists and regulators in ensuring clinical trials of investigational medicinal products are conducted in accordance with the Medicines for Human Use (Clinical Trials) Regulations: including preparing for an MHRA Inspection.

    Legal Requirement for some em studies (not applicable for all) Date added: 23 October 2008
  • 4. MRC DT Tool Kit: Audit and Inspection

    Provides practical guidance on how to obtain, store, and use personal data / information in research. Clear guidance is given on risk-based audit and preparing for Inspection.

    Legal Requirement for some em studies (not applicable for all) Date added: 23 October 2008