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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. NIHR Clinical Trials Toolkit: Audit

    NIHR Clinical Trials Toolkit guidance on auditing clinical trials conducted in accordance with the Medicines for Human Use (Clinical Trials) Regulations.

    Legal Requirement for some em studies (not applicable for all) Date added: 23 October 2008
  • 2. NIHR Clinical Trials Toolkit: MHRA Inspection

    NIHR Clinical Trials Toolkit guidance on MHRA inspection of clinical trials conducted in accordance with the Medicines for Human Use (Clinical Trials) Regulations.

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