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Useful Links and Documents


Useful links

Is my study research? Sometimes what is deemed research at BU, is not classed as such within the NHS. The tool can help decide for you, as well as the Defining Research table.

Do I need NHS REC approval? – in the majority of cases, you will need to apply to the NHS Research Ethics Service for approval for your project. This tool helps you decide if this is a requirement.
Email Research Ethics for further guidance.

Do I need a clinical trial authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA)?

The storage of human tissue or other relevant materials for research, may require a licence from the Human Tissue Authority, which BU does not currently hold.
Please note – if you are collecting materials, rendering them acellular, and then extracting DNA, you will need NHS REC approval. This is referenced in the HTA Research Code of Practice, found here.
Email Research Ethics for further guidance.

The UK Policy Framework for Health and Social Care Research sets out principles of good practice in the management and conduct of health and social care research in the UK.

It’s important to register your study – the Research Ethics team have the appropriate access to provide user accounts to this system.


Useful documents

There are plenty of template documents available to help you with study conduct, through the NIHR website (you will be aware of them through GCP training). Remember to check with your research site as well, as they may have handy templates to offer you.

The Health Research Authority have provided templates and guidance for creating your PI Sheet and informed consent form. Similarly, they offer guidance and templates for writing your study protocol.

In addition to your study documents (protocol, PI Sheet, etc.) the Health Research Authority also require you to submit a Statement of Activities and Schedule of Events. Further guidance can be found here and by emailing Research Ethics.

R&KEO suggested index for your study files (site-specific and Sponsor file). This document clearly sets out which documents a study monitor would expect to see in your files.

Workflows

Clinical Governance workflows are now available via Sharepoint for the following procedures. Please get in touch if you have any queries surrounding these process:

Amendments
Archiving
BU Ethics 
BU Sponsorship
Informed Consent
IRAS Application (an overview)
Monitoring
NHS site C&C assessment (Capacity & Capability)
Progress Reporting
Reporting Deviations, Violations and Serious Breaches
Safety Reporting
Staffing and Delegation