Study Initiation and Management: Study management and monitoring

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Introduction

The UK policy framework for health and social care research outlines the sponsor(s) responsibility to ensure that before a study begins, arrangements are in place to allocate responsibilities for the management and monitoring of the research.

Risk management and monitoring can be conducted within individual studies by the investigator and their research team; and by the employer of the research team, or sponsor(s), if different. More information is available in Risk management and monitoring.

Investigators and members of the research team should allow employers (or sponsor(s) if different) to access study documentation for the purposes of monitoring and/or audit. Information about access to participant information for these purposes should be included in the consent from participants.

During the course of the study it is important to ensure that there are mechanisms for effectively managing and minimising recurrence of any adverse incidents, for example an inadvertent breach of confidentiality. For this it would obviously be important to ensure that all steps are taken to minimise the spread of information, that any affected participants are appropriately recompensed for their distress, and that lessons are learnt to prevent recurrence. Guidance on safeguarding confidentiality is available in section 5 in the resource below.

It is good practice to report any adverse incidents to the sponsor(s) of the project, please see Reporting for more information.

Resources

  • 1. 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 data Date added: 4 September 2007