Screened | Eligible |
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• Develop criteria for entry into the screening process and include instructions on the SEAR log (ideal) • Record basic patient details: age, gender, screening ID, initials (kept locally) • Record basic clinical data for key screening or eligibility criteria as appropriate | • List the inclusion and exclusion criteria on front or back of SEAR log • Note final outcome of eligibility checks against trial inclusion and exclusion criteria • Record reason ineligible using trial inclusion and exclusion codes |
Approached | Randomised? |
• Date written information provided • Date trial discussed and recruiter initials • Invited to take part in trial (Y/N) • Record reason for non-approach | • Final outcome of screening process (ineligible, not-approached, declined, randomised) • Record reason to decline the trial • Treatment received by eligible patients outside the trial (recorded on screening log or elsewhere as appropriate) |