[Acknowledgements: Prof David Hutchinson, Canary Ltd]HRA_site-logo_small copy
In collaboration with a wide range of partners, the Health Research Authority (HRA) has published a template and guidance for protocols for clinical trials of investigational medicinal products (CTIMPs). This is the first in a suite of templates for health research. The templates will be particularly valuable to new researchers, but the main aim is to provide clarity about the information that reviewers need to assess research projects, and that research teams need to conduct the project effectively.
The HRA templates will not be mandatory, but in due course applicants who use the template will have fewer questions to complete in IRAS.
All stakeholders, whether authors, reviewers or users for completed protocols, are invited to provide feedback that will inform future guidance and templates.
Janet Messer, Director of Systems and Development at HRA said, ‘Our aim is to improve the quality of clinical trial protocols by defining information to be addressed in a protocol. We are delighted to have had support from such a wide group of researchers and organisations in developing this template, including the international SPIRIT guideline team. A protocol which follows this template is less likely to be delayed during the review process because it will provide the necessary information needed by reviewers.’
This template utilises clear embedded guidance that assists authors by providing specific aims, rationale and points to consider for all sections of the protocol. The template can be used by all individuals and sponsoring organisations preparing any phase of CTIMP.
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