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Prepare study documentation

Last updated on 12 Jun 2018
When applying for HRA Approval you will need to check what supporting documents you will need to provide well in advance of when you expect to submit your application. This will avoid unnecessary delays to your application.

Make sure that you attach all of the required supporting documentation for your project, and that they are all dated and version-controlled. Lack of date and version number is one of the main reasons that applications can not be validated.

The documents you will require will include:

Protocol

Your protocol is a full description of your research study and will act as a ‘manual’ for members of the research team to ensure adherence to the methods outlined. More information on what your protocol should contain, and protocol templates can be found here.

Participant Information Sheet (PIS)

Your Participant Information Sheet (PIS) should describe clearly what a potential participant should expect if they agreed to take part in your study. Our online consent guidance contains more information and templates for creating a PIS. Our General Data Protection Regulation (GDPR) guidance outlines how the legislation affects the information you are expected to provide to participants. 

Other documents you may be asked to supply, depending on the type of research and the application being made could include:

Statement of activities and schedule of events (non-commercial research)

The Statement of Activities and Schedule of Events should be used to provide information on participating NHS organisations in England and Wales. A template Statement of Activities for each site type should be completed and accompanied by a completed Schedule of Events as part of your submission. The two documents allow the sponsor to make clear what activities will be undertaken locally and the cost type for each activity. Our guidance for use with the statement of activities will help you to complete the statement.

Industry costing template

The Industry Costing Templates provide a framework for transparent cost display and calculation to support swift local site budget negotiations when performing commercial trials in the NHS. Visit the NIHR website for guidance and templates.

Model Agreements

Any changes to the model agreement must be made clear in your application. Visit the UKCRC website for guidance and templates.

Manuals

If you are using NHS facilities, a laboratory manual and a pharmacy manual should usually be provided.

Funding letter

This may be required if the study is applying for adoption to the NIHR Clinical Research Network Portfolio.

Curriculum Vitae

Guidance and a standard template for an investigator CV is provided for your use.  This template would be suitable for submission of CVs by Chief Investigators, local Principal Investigators and academic supervisors (for submission with student applications).  

Research passports and honorary contracts or letter of access

The NIHR's Research in the NHS: Human Resource (HR) Good Practice Resource Pack describes the process for handling HR arrangements for researchers and provides a streamlined approach for confirming details of the pre-engagement checks they have undergone with the NHS. Visit the NIHR site for more information.

Helpful documents and resources

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