Chronic rhinosinusitis trials join an endoscopist's polyp score, a daily congestion diary, a symptom questionnaire and a CT. Capture holds the clinic exam and the participant diary in one study, with an audit trail. Test free, pay only at go-live.
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| Assessment | Screen | Baseline | Wk 4 | Wk 16 | Wk 24 | Wk 52 |
|---|---|---|---|---|---|---|
| Endoscopic polyp score (per side) | ||||||
| Daily congestion diary | D | D | D | D | D | D |
| Sinonasal symptom questionnaire | ||||||
| Sinus CT scoring | ||||||
| Smell identification test | ||||||
| Rescue steroid or surgery log |
x = visit form, D = daily diary on participant phone
What a chronic rhinosinusitis trial needs from its EDC
The study data
Registered trials in CRSwNP, from tezepelumab to benralizumab and mepolizumab, set a co-primary pair: the change from baseline in the endoscopic total nasal polyp score and the change in a nasal congestion or blockage score, measured between week 16 and week 56 depending on the programme. A Danish head-to-head registration instead pairs the polyp score with the SNOT-22 questionnaire. Secondary endpoints are usually the sinonasal questionnaire and the Lund-Mackay CT score. The nasal polyp score is the sum of a 0 to 4 grade per side (total 0 to 8); SNOT-22 has 22 items scored 0 to 5; Lund-Mackay scores sinus opacification to a maximum of 24. Confirm these ranges against your protocol.
The first data risk is that the diary endpoint is a mean over days, and a participant who stops answering after week 8 is not the same as one who answers with low scores. In Capture, a diary is a participant questionnaire with a daily schedule, reminders by email or SMS and a completion window you control, opened from a secure link on the participant's own phone. A dashboard of completion per participant shows gaps while the study runs, not at database lock. See ePRO compliance and diary completion rates.
The second risk is the exam. The endoscopy score is entered per side, and where a central reader reviews recorded video the site score and the central score both exist. Create both as separate fields with a reader field, keep the analysis score decision in the SAP, and use an edit check to flag a difference between site and central grades you consider material. Capture does not store or view endoscopy images itself; keep the image transfer to the reader outside the EDC and record the file reference or reading date.
Left side polyp grade
NPSLRight side polyp grade
NPSRTotal polyp score
NPSTLeft plus right, read-only
3 CalculatedSystemic steroid course since last visit
RESCUEDiary completion, last 28 days
DIARYCBelow the 80% threshold set for this study
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Nasal polyp score | Grade per side, total, site and optionally central | Site eCRF form with calculated total |
| Congestion diary | Daily 0-3 style score, 14 or 28 day means | Participant questionnaire on a daily schedule with reminders |
| Sinonasal symptom questionnaire | 22 items, total, visit recall | Participant questionnaire at scheduled visits |
| Sinus CT | Lund-Mackay score per sinus, date, reader | Site form per scan with sinus rows as table sections |
| Smell testing | Identification test total, date, version | Site form; licence stays with study documents |
| Comorbid asthma and allergy | Asthma control, aspirin sensitivity, eosinophils | Medical history and lab forms; see asthma control test template |
| Rescue treatments | Systemic steroid courses and surgery with dates | Repeating rows, own audit trail each |
| Adverse events | Epistaxis, injection reactions, infections | Adverse event form |
Instrument wording is yours to supply. Licences stay with your study documents; Capture licence controls exist only on participant questionnaires.
Build the exam form and the daily diary, enter sample participants and see the completion view. Free sandbox, no credit card.
Design variants
Biologic trials use injections or infusions every two to four weeks, so each dosing visit carries a dose time, site and reaction record in addition to the exam. Add an eosinophil count and total IgE at baseline from the lab form if the protocol stratifies by them. For asthma, aspirin sensitivity and allergy as comorbidity, see EDC for COPD and asthma trials for the respiratory side of the same patients.
Surgical and device-delivered studies, such as steroid-eluting implants or balloon sinuplasty, shift weight to the procedure form: date, side, technique, intra-operative findings and post-operative events. Use the visit editor for post-operative windows and unscheduled visits for debridement. A randomised device comparison can use clinical trial randomization software; blinding in surgery is usually partial, so the data you need is who knew what.
Chronic rhinosinusitis without polyps is a distinct population with different endpoints, usually symptom-based without an endoscopic polyp score as co-primary. Build the form set accordingly rather than copying a polyp trial. In every design the principle is the same: separate the clinic-rated data from the participant-rated data, record who rated, and keep rescue events dated.
Before first participant
Daily time window, reminder rule and completion threshold agreed.
Site grade, central grade and how disagreement is handled.
Questionnaire and smell test terms recorded in study documents.
Site or central; the sinus rows and score total built.
Steroid and surgery logs with the analysis rule stated in the SAP.
CSV with data dictionary, one row per submission.
Yes, as separate fields with a reader field. Capture does not host endoscopy video; the image transfer to the reader sits outside the EDC.
Yes. A daily diary opens from a secure link in the phone browser with reminders and a completion window you set. No app to install.
Yes. Completion is visible by participant and site, so gaps can be followed up before the endpoint window closes.
Yes, summed totals can be calculated and shown read-only on forms. Your protocol decides how the endpoint is derived.
Yes. Capture suits Phase 1, 2 and 3, with multi-site numbering, a site coordinator portal and by-site exports.
The sandbox is free. Live studies are billed per the pricing page, with per-participant fees counted from screening.
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