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 |