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- Substantial protocol change: Updated to indicate that eligibility can be confirmed and consent obtained by members of the research team (which may include research nurses, research practitioners, research associates and research coordinators) who have local approval to do so and are authorised onto the delegation log with the consent taking role.
- Non-substantial protocol change: Minor formatting updates. Removed reference to COVID-19 status being checked post randomisation. Clarified that the treatment period during which all SAEs need to be reported is within the first 20 days after randomisation (fatal SAEs and safety outcome events continue to be reported from randomisation until day 90). Clarified that non-serious AEs do not need to be reported to the coordinating centre.
- Information sheets: wording amended to indicate that there will be a gap of >4 hours between intervention doses (correction to align with existing approved protocol), and updated to provide space for local PALS and research team contact details to be documented.
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- The amendment involves an update to the device model and manufacturer (AT4 Electronic Tourniquet System, Medical Device Management Ltd.) and relevant changes to the protocol and patient-facing documentation.
- Full details of the updates are listed in the amendment tool.
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- The amendment involves an update to the device model and manufacturer (AT4 Electronic Tourniquet System, Medical Device Management Ltd.) and relevant changes to the protocol and patient-facing documentation.
- Full details of the updates are listed in the amendment tool.
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