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Eligibility
Local study conflicts
Any co-enrollment conflicts
Inclusion Criteria:
etc
etc
Exclusion Criteria:
etc
etc
If the patient is eligible:
Gain verbal agreement in principle before proceeding. Explain:
Taking part in research is likely to improve the quality of their care
Risks are carefully controlled - research is safe
Explain the uncertainty that exists with respect to treatment of their condition
If they change their mind they can withdraw their participation at any point
Step-by-Step Guide to Recruitment:
In standard working hours; 9-5
Out of hours and weekends:
Gather documentation
Where to collect documentation
Gaining formal consent
Steps to consent and document it
If capacity/no capacity are different; get the framework from comited in emerg-sci.web.app
etc
Randomisation procedure
Randomisation steps
Carrying out the intervention:
[steps undertaken]
Disposition and follow-up:
If admitted:
Any required information
If discharged:
Any required information