ALIC4E schedule of procedures
Screening | Baseline day 1 | Day 1–14 | Day 14–28 | Post day 28 | |
Eligibility assessment* | ✓ | ||||
Informed consent*† | ✓ | ||||
Baseline CRF* | ✓ | ||||
Physical examination* | ✓ | ||||
Swab(s)* | ✓ | ||||
Randomisation* | ✓ | ||||
Dispensing of trial drugs* | ✓ | ||||
Symptom diary† | ✓ | ||||
Day 2–4 phone call‡ | ✓ | ||||
Day 14–28 phone call‡ | ✓ | ||||
After day 28 phone call‡ | ✓ | ||||
Clinical notes review§‡ | ✓ | ||||
Adverse event assessments‡ | ✓ | ✓ | |||
SAE follow-up‡ | ✓ | ✓ |
*Completed by recruiter.
†Completed by participant, includes standardised written health-related quality of life assessment and documents resource use.
‡Completed by trial team (Chief Investigator/Principal Investigator/coordinator), day 28 call includes standardised verbal health-related quality of life assessment.
§Country dependent.
ALIC4E, Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE; CRF, case report form; SAE, serious adverse event.