Source Data Verification Consent and Eligibility – Patient Information Correct PIS/consent Trial Number: versions signed? Initials: Pt initialled all boxes? Pt signed and Date of Birth: personally dated? Person taking consent Sex: signed and dated? Date Name of person Randomised: taking consent: Person taking consent PIS version: on delegation log? Date consent signed Consent version: by both parties: Eligibility Inclusion Criteria check Eligibility Exclusion Criteria check – – Inability or refusal to 50 years or over provide informed consent Anticipated requirement for invasive or mechanical Elective Major ventilation for at least four Surgery using hours after surgery as an open technique part of routine care Pregnancy or obstetric surgery Previous enrollment in PRISM trial Participation in a clinical trial of a treatment with a similar biological mechanism or related primary outcome measure Clinician refusal Confirm patient eligible: Yes / No Comments: Monitor name Signature
Source Data Verification – Consent and Eligibility Patient Information Trial Number: Correct PIS/consent versions signed? Initials: Pt initialled all boxes? Date of Birth: Pt signed and personally dated? Sex: Person taking consent signed and dated? Date Randomised: Name of person taking consent: PIS version: Person taking consent on delegation log? Consent version: Date consent signed by both parties: Eligibility – Inclusion Criteria check Eligibility – Exclusion Criteria check 50 years or over Inability or refusal to provide informed consent Elective Major Surgery using an open technique Anticipated requirement for invasive or mechanical ventilation for at least four hours after surgery as part of routine care Pregnancy or obstetric surgery Previous enrollment in PRISM trial Participation in a clinical trial of a treatment with a similar biological mechanism or related primary outcome measure Clinician refusal Confirm patient eligible: Yes / No Comments: Monitor name Signature
PRISM%20Monitoring%20Visit%20-%20Consent%20&%20Eligibility%20Checklist%20v1.0%2020-06-2016.docx