Smoking cessation trials are won or lost on one date, the quit date, and on how well you follow people who relapse and go quiet. Capture holds the quit-date schedule, self-reported abstinence, breath and saliva verification, daily check-ins and medication use in one study with one audit trail. Build it free in the sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Assessment | Screen | Wk -1 | Quit day | Wk 1 | Wk 4 | Wk 12 | Wk 26 FU |
|---|---|---|---|---|---|---|---|
| Smoking history and dependence questionnaire | |||||||
| Daily craving and cigarette count diary | D | D | D | D | |||
| Self-reported abstinence (7-day and since quit date) | |||||||
| Expired-air CO reading | |||||||
| Medication use and adverse events |
x = done at this visit, D = daily phone check-in
What a smoking cessation trial needs from its EDC
The study data
Cessation trials come in three common flavours: pharmacotherapy trials against placebo or an active comparator, behavioural and digital programme trials (counselling, text-message and app interventions), and pragmatic trials in routine settings such as hospitals and primary care. Almost all share an outcome structure. Registered protocols define seven-day point-prevalence abstinence (not even a puff in the past seven days) and continuous abstinence since the quit date, usually with follow-up at several months, and verify self-report with an expired-air carbon monoxide reading and sometimes saliva cotinine. The exact thresholds differ between protocols: published and registered trials use different CO cut-offs and grace periods, so write yours into the protocol and the form, not into a default.
The design implication is that each follow-up needs several separate fields. The date. The participant’s self-report for the past seven days. Whether they have smoked at all since the quit date and the date of any lapse. The verification method and the reading. Whether verification was refused, not done or failed. A single combined abstinent yes/no field hides the information that the analysis plan needs to apply its own rules, including how the many participants who stop responding are handled. Many trials count those as smokers by convention, so make sure the dataset shows them clearly.
Baseline data describes dependence and history: cigarettes per day, time to first cigarette, previous quit attempts, other tobacco and nicotine products, and household smokers. Name the dependence scale your protocol uses, and keep its licence terms with the study documents; Capture does not supply licensed instruments. Mood and anxiety can be tracked with forms such as the PHQ-9 template and the GAD-7 template where the protocol monitors them.
Craving and lapse patterns are best captured close to when they happen. Build a short daily questionnaire (cigarettes smoked, craving on a 0 to 10 slider, mood, medication taken) that opens from a link in the phone browser, with no app install. Reminders and completion windows keep the diary honest, and the compliance view shows by site which participants have stopped responding, so a coordinator can phone before the follow-up visit. The pattern is described under ecological momentary assessment software and ePRO compliance and reminders.
Self-report and verification
Any smoking in the past 7 days, even a puff
SMK7DAny smoking since the quit date
SMKQDDate of first lapse
LAPSEDTExpired-air CO
COPPMVerification status
COSTATCut-off is set in the protocol, not in the form
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility | Daily smoking, motivation to quit, other tobacco use, medical exclusions, current medications | Eligibility form with skip logic |
| Baseline history | Cigarettes per day, time to first cigarette, past quit attempts, household smokers | Baseline eCRF form; dependence scale as a participant questionnaire |
| Randomization | Arm, stratification (for example cigarettes per day, site) | Randomization in the same platform |
| Daily diary | Craving, cigarettes, lapse, mood, medication taken | Phone check-in in built-in ePRO with reminders |
| Abstinence outcome | Self-report, lapse date, CO reading, cotinine, verification status | Visit eCRF form; separate fields for each |
| Treatment exposure | Medication start, dose, adherence, counselling sessions attended | Repeating exposure form; see medication adherence capture |
| Safety | AE term, grade, seriousness, relationship, action | Adverse event form |
Capture records the data your protocol defines. Abstinence definitions and missing-data rules are applied by the statistical plan.
Upload the protocol, let the AI draft the visits and forms for review, then run a practice participant through quit day, a lapse and a missed week 12. Free sandbox.
Safety reporting
Stopping smoking is itself associated with mood change, sleep disturbance and irritability, which makes attribution to the study drug difficult. Record onset date, grade, seriousness and relationship as separate answers, and give the investigator the participant’s smoking status at onset by linking the AE to the nearest diary entry. Pharmacotherapies commonly bring nausea, sleep disturbance and vivid dreams, so a protocol may ask about specific events each visit. Where the protocol monitors mood or suicidality, add a structured scale such as the C-SSRS template and keep results on a site form.
Serious events follow the SAE report form, and the AE causality assessment page shows how relationship fields are structured. For a behavioural trial with no drug, safety is usually light, but record any distress, injury or lapse-related events the protocol names.
Concomitant medication matters in cessation work, because smoking changes how the body handles some drugs. Record changes in the concomitant medications form with start and stop dates, and consider an edit check that raises a query when a medication change is recorded within a short window of the quit date.
Cannot submit yet
Causality is required because the event is serious.
Build sequence
A realistic order of work for an academic or clinic-based team.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the schedule and forms. Nothing is saved until a person reviews it.
Quit date as a baseline field, visit windows counted from it, and edit checks that flag a visit outside its window.
Separate fields for self-report, lapse date, CO or cotinine, and verification status.
A short phone questionnaire with reminders and a completion window for the weeks around the quit date.
Run practice participants through a lapse, a refused breath test and a missed follow-up, check the export, approve the forms and start the paid live phase when real participants enrol.
Recruitment, sites and exports
Cessation trials often need hundreds of participants recruited through clinics, quitlines or online. Capture supports QR-code enrolment with site-specific or study-specific codes and no app install; see QR code participant enrollment and remote patient enrollment software. Consent can be completed remotely with eConsent. Where the intervention is behavioural, the broader pattern is described under EDC for behavioural health studies.
Where verification is by post (a saliva kit) or at a clinic, record the dispatch date, the return date and the result on a repeating row, so that outstanding samples are visible. Exports come as CSV or Excel with an automatic data dictionary (export EDC data to R, SAS and SPSS). Sample size for a binary abstinence outcome can be started with the two proportions sample size calculator, and drop-out inflation with the dropout-adjusted calculator.
Before first participant
Point-prevalence and continuous abstinence wording, grace period and verification thresholds in the protocol.
Who takes the CO reading, with which device, and how a refused or missed test is recorded.
How lost, withdrawn and unverified participants are coded for analysis.
Permitted shift of the quit date and how the schedule moves.
Questionnaire terms confirmed with their rights holders and kept in the study documents.
Wide CSV with data dictionary opened in the statistics package.
Yes. Build separate fields for the 7-day self-report, any smoking since the quit date, the CO or cotinine result and a verification status. Your statistical plan applies the abstinence rules.
Record the quit date as a baseline field and build visit windows from it in the schedule. Edit checks flag visits outside their window.
Yes. A short questionnaire opens from a secure link in the phone browser with no app install, with reminders and a completion window you set.
The EDC records visit status, refusals and withdrawals as separate answers. How they are counted in the analysis, often as still smoking, is set in your statistical plan.
Yes. Session attendance, programme use and daily check-ins are recorded as data, alongside the same outcome and verification fields used in drug trials.
Capture provides 21 CFR Part 11-aligned controls: a field-level audit trail, electronic signatures and role-based access. Compliance is shared with the sponsor’s own validated use of the system. This is not legal advice.
Keep exploring
EDC for behavioural health studies
Behavioural interventions and session data.
Ecological momentary assessment software
Short in-the-moment phone check-ins.
QR code participant enrollment
Enrol participants with no app install.
Two proportions sample size calculator
Size a binary abstinence endpoint.
Capture ePRO
Questionnaires, reminders and completion windows.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.