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Table 1 Streamlining the hospital approval process

From: Design and implementation of a large and complex trial in emergency medical services

Normal process

AIRWAYS-2

Rationale for streamlining

Advantage for hospital

Site-specific assessment form for each hospital

Generic site-specific form for all hospitals

 

No need for hospital to complete information about local site activities

Patient consent and information forms on local hospital trust headed paper

Patient consent and information forms on sponsor/trust headed paper

Patient recruitment being carried out by ambulance services. No change of practice in hospital and activity limited to follow-up

No need for hospital to spend time localising patient documents, as documents provided to hospital by study team on ambulance trust/sponsor headed paper

Principal Investigator

Local collaborator

No serious adverse events expected to occur in hospital; likely to occur at roadside and would be reported by ambulance trust

A research nurse, rather than a doctor, could act as the hospital’s main point of contact for the study

Third-party contract requiring sign-off at each hospital

Simple one-page document ‘statement of responsibilities’ issued to hospital sites; no signature required

Hospital not responsible for participant enrolment or delivering intervention so a simpler agreement is sufficient

No complicated legal terminology for contracts department to review. No signature, therefore less administration for research and development teams