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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 Tool Kit (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. CT Tool Kit: Archiving

    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 detailed guidance on the archiving of trial data.

    Legal Requirement for some em studies (not applicable for all) Date added: 23 October 2008
  • 3. MRC Ethics Series: Personal Information in Medical Research

    This document sets out the principles that MRC-funded scientists must follow when collecting information about people whether it be drawn from surveys, medical records, scientific tests or interviews. This guidance outlines legal as well as ethical considerations.

    Good Practice for some em studies (not applicable for all) Date added: 23 October 2008
  • 4. MRC Ethics Series: Good Research Practice (2012)

    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