CLiREN-LMS
Protocol Translation and CRF Design

Primary and Secondary Outcomes

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30-45 minutes Foundational Step 6 of 7
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Table 1

QuestionWhy it mattersExample
What is the outcome definition?Ensures consistent classification"Clinic attendance within 30 days" must define eligible visit types
When is the outcome assessed?Aligns data collection with protocol timingDay 7, day 28, six months, discharge
What is the source document?Supports verification and auditClinic register, laboratory report, follow-up form
What format is required?Supports analysisBinary, date, numeric value, category, time-to-event
Are derived variables needed?Guides raw variable captureDays from discharge to attendance
How will missing outcomes be handled?Prevents ambiguity in analysisLost to follow-up, refused, died, unable to contact