Writing a protocol

Covering page

Research protocols generally start with a covering page containing logos of key organizations involved alongside the essential information, including the title, ethics reference, date and version number, a list of investigators, funders and sponsors, and important statements on confidentiality and conflict of interest:

Full study title

The full study title should be descriptive rather than creative. The UK research ethics service recommends the IPOC rule for choosing a study title: Intervention, Population, Outcome, Comparator (if there is one). This often leads to a dense title, such as ‘The impact of recorded music vs. benzodiazepine in reducing pre-surgical anxiety among adults undergoing elective gastrointestinal surgery’.

Internal reference number/short title

The short title for a research study is typically no more than 20 characters and is a recognizable simple reference to the project, such as an acronym or the key words.

Ethics reference

If the study requires ethical approval, the ethics reference number is often stated right at the start. Prior to ethical approval being granted, this section is often left blank, with the number added once ethical approval is received. Once the study has ethical approval, it is not normally possible for changes to the protocol to be made without additional correspondence with the ethics committee.

 
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