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Protocol Development

The research protocol is the document that describes the research question, the rationale for the study, the main objectives (outcomes), the design and organisation (study management and oversight), statistical considerations, methodology, safety and risk management procedures, and plans for publication at the end of the study.

The protocol should be as detailed as possible, this will enable the reviewing bodies to understand the study and for local investigators to follow step by step instructions to ensure adherence. It should be identified on the cover by the study title (and a short title to which the study can easily be referenced (acronym),  the unique sponsor’s protocol reference number (which will be assigned to the study following a sponsorship request), and other relevant unique identifiers/registration references (such as EudraCT for CTIMPs) and the date and version number (the protocol must be a version controlled document, the version should be updated further to any amendments during the study).

Noclor has developed a CTIMP protocol template (adapted from HRA template) and its use is mandated for researchers developing protocols for Clinical Trials of Investigational Medicinal Products (CTIMPs) where a Noclor partner is the proposed sponsor. 

The Chief Investigator should retain all drafts copies of the protocol (work-ups with any comments) as well as all subsequent approved versions for the Study/Trial Master File (drafts should be version referenced so that the audit trail of the protocol development is evident on file).

Writing groups & peer review

For clinical trials, Noclor recommends that researchers make a note to file of the personnel involved in the writing of the protocol and any review groups where this information is not explicitly documented elsewhere (such as in grant application or protocol itself). 

Noclor will ensure that the quality of science in a research protocol has been subjected to peer review by independent experts in the field prior to final declaration of sponsorship (by the Noclor partner) and authorising subsequent REC submissions (and other submissions where relevant).

Don’t forget to involve users in developing the protocol and utilise the services of the  NIHR Research Design Service (RDS) if you are planning a research proposals for submission to NIHR and other national, peer-reviewed funding competitions. 

If you are in doubt as to where to go for advice or guidance or where to start when writing your protocol, contact the Noclor office and someone will be able to assist you. 

Finalised protocol sign off

The protocol must be finalised prior to submission to REC and other review or regulatory bodies. The protocol should include a signature page, the Chief Investigator must sign off the final protocol as a minimum requirement.  For CTIMPs the Sponsor Representative is also a required signatory on the protocol.  Noclor also recommends that the trial statistician is included as a required signatory for clinical trial protocols where a trial statistician has been/will be delegated responsibilities on the study (this is not mandated). 

The Principal Investigators are required to sign off on a protocol signature page, this may be incorporated within the protocol or a separate signature sheet.  If this is a separate sheet it should specify the study title, protocol version, relevant study references (sponsor protocol ref as a minimum), Chief Investigator details, Principal Investigator and site detials.  The Principal Investigator protocol signature sheet should be collected at site initiation and is one of the checklist items for clinical trials prior to the Noclor Sponsor Representative issuing a site study activation notice).