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Funding & Approvals: Finalise study documents

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Introduction

Finalise protocol/proposal (including your risk assessment), all relevant agreements, participant information sheets, consent forms and all other study documentation required to ensure the study can be conducted safely and efficiently.  Ensure all members of your research team have copies of the final documentation, that is the versions approved by the ethics committee, the funder(s) and NHS Research and Development.

It is good practice to exercise some form of version control (e.g. marking documents with version numbers or with the dates on which they were finalised).  This will avoid possible confusion if the protocol or any other documentation needs to be amended once the study is underway (e.g. in response to an emerging safety issue). 

As Chief Investigator, you are responsible for ensuring all members of your research team have read and understood the protocol, the role(s) they are being asked to undertake, and any relevant safety information.  Failure to do so not only potentially compromises the safety of participants, but also the integrity of the data collected.