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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