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Study Files and Monitoring

Managing your study files (primarily aimed at staff and postgraduate research students but can be used by undergraduate and postgraduate taught students if appropriate)

• We recommend that you set up an for your study files. This document clearly sets out which documents a study monitor would expect to see in your files.
• for your documents held in study files

Monitoring (non-clinical projects) - Staff and Postgraduate Research Students only

BU has an obligation to ensure that research participants and its staff and students are safeguarded, whilst maintaining oversight of the research activity taking place.  Studies will be selected at random and the researchers and colleagues will be notified by the Governance team of their intention to monitor.

How to apply for an Amendment

Amendments are changes made to a research project after approval has been given.  Reasons can vary but could include:

• a change to the project end date
• a change to the Research Team
• a change in the number of participants
• changes to the design or methodology of the study
• changes to the participant's involvement/activities
• changes to study documentation such as participant information sheet, agreement forms, questionnaires
• any other changes that would impact on a previously approved ethics checklist

What is the procedure for requesting an amendment?

All requests should be made via the .  On your ‘Dashboard’ click the corresponding Amendment Icon and an Amendment Request Form will pop up for you to complete (this icon only appears when the checklist has been approved).  If required, you can attach documents e.g. revised PI sheet and/or Participant Agreement Form or questionnaire to the Amendment Request Form.