Cameron, Claire;
(2025)
HWFinEL Protocol v2.0 27May2025.
[Digital scholarly resource].
https://www.ucl.ac.uk/ioe/departments-and-centres/...
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HWFinEL Protocol v2.0 27May2025 - clean.pdf - Accepted Version Download (1MB) | Preview |
Abstract
This document was constructed using the Comprehensive Clinical Trials Unit (CCTU) at UCL Protocol template Version 7. It describes the HWFinEL trial, sponsored by UCL and coordinated by CCTU. It provides information about procedures for entering participants into the trial, and provides sufficient detail to enable: an understanding of the background, rationale, objectives, trial population, intervention, methods, statistical analyses, cost-effectiveness analyses, ethical considerations, dissemination plans and administration of the trial; replication of key aspects of trial methods and conduct; and appraisal of the trial’s scientific and ethical rigour from the time of ethics approval through to dissemination of the results. The protocol should not be used as an aide-memoire or guide for the treatment of other patients. Every care has been taken in drafting this protocol, but corrections or amendments may be necessary. These will be circulated to registered investigators in the trial. Sites entering participants for the first time should confirm they have the correct version through a member of the trial team at CCTU. CCTU supports the commitment that its trials adhere to the SPIRIT guidelines. As such, the protocol template is based on an adaptation of the Medical Research Council CTU protocol template and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement for protocols of clinical trials. The SPIRIT Statement Explanation and Elaboration document can be referred to, or a member of CCTU Protocol Review Committee can be contacted for further detail about specific items.
| Type: | Digital scholarly resource |
|---|---|
| Title: | HWFinEL Protocol v2.0 27May2025 |
| Open access status: | An open access version is available from UCL Discovery |
| Publisher version: | https://www.ucl.ac.uk/ioe/departments-and-centres/... |
| Language: | English |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Population, Policy and Practice Dept |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10210912 |
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