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Study Management & Closure: Archiving research documentation

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Introduction

Research records need to be preserved for the longer-term for a number of reasons.  They may be needed:

  • For scientific validation of the research,
  • For future research and audit, and
  • Occasionally by patients themselves (or their treating clinicians) who may have continuing long-term concerns about their own health (for instance, where trials of novel treatments were involved).

Documentation relating to clinical trials of investigational medicinal products (i.e. drug trials) must be archived in accordance with the Medicines for Human Use (Clinical Trials) Regulations.  Guidance is available on the Clinical Trials Toolkit (see below).

Resources

  • 1. MRC DT Tool Kit: Archive Data / Tissues

    Provides practical guidance on how to obtain, store, and use personal data / information in research. Clear guidance is given on the archiving of data and human tissue samples after a study has ended.

    Good Practice for all research Date added: 23 October 2008
  • 2. NIHR Clinical Trials Toolkit: Archiving

    NIHR Clinical Trials Toolkit guidance on archiving for 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 Ethics Series: Using information about people in health research

    This practical guidance reflects the current relevant legal framework when using information about people in health research. It will be revised to reflect the new GDPR, which is expected to come into force on 25 May 2018.

    Good Practice for some em studies (not applicable for all) Date added: 23 October 2008
  • 4. MRC Ethics Series: Good Research Practice

    This document sets out the principles that MRC-funded scientists must take into account when planning and conducting research, and when recording, reporting, and applying the results

    Good Practice for all research Date added: 23 October 2008