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Developing your research protocol

Every research project must have a protocol. The National Research Ethics Service defines a protocol as:

"an essential part of a research project. It is a full description of the research study and will act as a 'manual' for members of the research team to ensure adherence to the methods outlined. As the study gets underway, it can then be used to monitor the study's progress and evaluate its outcomes"Visit their website.

When writing your protocol it is important to consider who else needs to be consulted during this process; colleagues, support departments, statisticians etc.  For further information, please see the Standard Operating Procedures page.  

To view examples of ethically approved UH Bristol sponsored trials please use the links in the table below:

Study Title

Chief Investigator

Study Type

Funder

Protocol example

Oesophageal squamous cell cancer: induction chemotherapy and oesophagectomy versus induction chemotherapy and chemoradiotherapy - a feasibility study

Professor Jane Blazeby

Surgical RCT

NIHR Research for Patient Benefit grant

Link to protocol

A Phase II, Open-Label, Single-Arm Study to Assess the Efficacy and Safety of Decapeptyl® SR (3 mg and 11.25 mg formulations) when administered by subcutaneous injection.

Dr Raj Persad

CTIMP

Ipsen

Link to protocol

A randomised trial of gum chewing vs. no gum to reduce post-operative ileus in patients undergoing large bowel resection

Dr Charlotte Atkinson

Clinical Trial Non-IMP

NIHR

Link to protocol

Can Ambulance Paramedics use FRAX® (the WHO Fracture Risk Assessment Tool) to help GPs improve Future Fracture Risk in Patients that Fall?

Dr Shane Clarke

Clinical Trial Non-IMP

NIHR

Link to protocol

A multi-centre randomised controlled trial of Transfusion Indication Threshold Reduction on transfusion rates, morbidity and healthcare resource use following cardiac surgery (TITRe 2)

Professor Barney Reeves

Clinical Trial Non-IMP

NIHR HTA Programme

Link to protocol

 

The NIHR Health Technology Assessment (HTA) programme publishes the protocols of all the trials they fund on their website. Each trial has its own project page which includes a link to the protocol: please click here

Further guidance for researchers wishing to develop a protocol for a clinical trial can be found in the SPIRIT statement. SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol. Further information can be found here: http://www.spirit-statement.org/

You may be developing a protocol to submit with a grant application. Click here for more information on grant writing

If you would like UH Bristol to act as Sponsor for your proposed research project please also ensure the required standard wording is included in your protocol.  Please see our 'Writing a research protocol' SOP