Substance use trials are decided by use days, urine results and who stays in treatment, all from participants who are hard to reach and need their records kept confidential. Capture holds the screens, the self-report and the retention data with role-based access. Build free, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Assessment | Screen | Wk 0 | Wk 1 | Wk 2 | Wk 4 | Wk 8 | Wk 12 |
|---|---|---|---|---|---|---|---|
| Urine drug screen (panel) | |||||||
| Self-reported use (Timeline Followback) | |||||||
| Daily craving and use check-in (phone) | D | D | D | D | D | D | |
| Withdrawal rating | |||||||
| Medication dispensing and adherence | |||||||
| Retention status |
x = visit form, D = daily phone entries
What an addiction trial needs from its EDC
The study data
Regulators have moved away from treating abstinence as the only acceptable result. FDA's October 2020 guidance on opioid use disorder endpoints says that drug-use patterns other than abstinence can be used to define a treatment response, and encourages sponsors to discuss alternative approaches to measuring change in use. For alcohol use disorder, FDA's 2015 draft guidance accepted the proportion of participants with no heavy drinking days as a primary endpoint, and the agency's drug development tool programme announced in February 2025 a qualified endpoint based on a two-level reduction in the WHO risk drinking level. Sources differ on the exact heavy-drinking threshold (commonly four or five standard drinks in a day, differing by sex), so take the definition from your protocol and put it in the form help text.
The practical consequence is that raw daily or weekly use data matters more than a final yes or no. The Timeline Followback interview reconstructs substance use day by day over a look-back window, and is administered by trained staff. In Capture it is a site eCRF form (or a repeating row per day or week) with the interviewer recorded in the audit trail. Urine drug screens are a laboratory form: analyte rows, result, cut-off, collection date and an explicit "not collected" status with a reason. A laboratory template is the layout to start from. Capture does not connect to point-of-care cups or to laboratories, so results are entered by site staff.
Participants change phones, lose housing and miss appointments, and that is not noise but a finding. Capture can run a short daily phone check-in on a secure link, with reminders and a completion window, covering craving, use since last entry and mood. See EDC for smoking cessation trials for the tobacco-specific design, and ePRO compliance and completion rates for how to monitor missed entries. A by-site view of overdue entries tells you who to call.
Many addiction trials test a behavioural intervention or an incentive schedule, not a drug. Build the intervention as a per-session form: session number, minutes, components delivered, therapist and any reward amount paid. A fidelity review can be a separate form completed by a second rater. For designs where the unit is a clinic rather than a person, see EDC for cluster-randomised trials. The digital intervention pilot page fits app-based recovery tools.
Sample collected
UDSCOLLCollection date and time
UDSDTCOpioid screen
UDSOPISelf-reported use in last 7 days
TLFB7Self-report and screen disagree: confirm
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and diagnosis | DSM-5 severity, last use, other substances, pregnancy status | Eligibility screening template with edit checks |
| Verified use | Weekly or visit urine screens, cut-offs, missing status | Laboratory-style form with "not collected" option |
| Self-reported use | Timeline Followback days, quantity, route | Site form or repeating rows; interviewer recorded |
| Daily symptoms | Craving, mood, use since last entry | Phone check-in with reminders (diary pattern) |
| Medication and adherence | Dose, dispensing, missed doses | Visit form plus concomitant medications template |
| Mood and suicidality | Depression, anxiety, suicidal ideation | PHQ-9, GAD-7 or C-SSRS layouts |
| Retention | Last visit attended, reason for discontinuation | Status form updated at each visit |
| Safety | Overdose, relapse events, injection-site reactions | Adverse event form |
Capture does not supply licensed instruments or verify licences. Licence controls exist only on participant questionnaires.
Build the screen, the interview and the check-in, then see in the sandbox how each missed visit shows up. Free, no credit card.
Confidentiality and safety
Substance use records carry stigma and legal sensitivity. In the United States, federal rules on the confidentiality of substance use disorder treatment records (42 CFR Part 2) apply to many treatment programmes, and NIH-funded researchers can obtain a Certificate of Confidentiality; whether either applies to your study is a question for your institution's counsel, not for software. What Capture provides is the technical layer: role-based access with PII segregation (site coordinators see participant names, researchers see coded IDs), a field-level audit trail of who viewed or changed what was recorded, and hosting in the EU (Frankfurt) or the USA (N. Virginia). Capture is described as HIPAA and GDPR ready; compliance is a shared responsibility with your own procedures.
Safety design depends on the substance and the drug. Opioid agonist and antagonist trials track overdose, precipitated withdrawal and hepatic safety; alcohol trials track liver tests and, depending on the molecule, mood and cognition; stimulant trials track cardiovascular events. Overdose is a recognised adverse event of special interest in many OUD protocols, and a form with seriousness and sign-off supports it. See adverse event reporting software for the serious adverse event workflow, and note that an edit check never replaces an investigator's response.
Consent has particular requirements when participants may be intoxicated or in withdrawal at screening. Many sites document capacity and re-confirm consent after stabilisation. eConsent records the timing of each signature and the investigator countersignature with re-authentication, which helps show what happened and when; the rules themselves come from your ethics committee. See eConsent software for clinical trials.
Build sequence
Write responder rules, heavy-drinking thresholds and missing-equals-positive rules into the data management plan before building forms.
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.
Add the urine screen with explicit missing reasons and the Timeline Followback form with the interviewer recorded.
Create the phone check-in with reminders; keep it under two minutes.
Log in as coordinator and as researcher in the sandbox and confirm who sees names.
Approved forms lock for live use. Real participants start the paid live phase.
Before first participant
The same definition appears in protocol, form text and analysis plan.
Cut-offs and which substances are tested, per site.
Who administers the Timeline Followback and how drift is checked.
Counsel has confirmed which privacy rules apply and the role set-up reflects them.
Alternate contacts, reminder cadence and a by-site list of overdue visits.
CSV or Excel with the data dictionary opened in the statistics package.
Yes. Build the screen as a laboratory-style form with analyte rows, cut-off, collection date and a "not collected" status with reason. Site staff enter results; no point-of-care or laboratory integration is claimed.
Yes, as a site eCRF form or repeating rows by day or week, with the interviewer attributed in the audit trail. The instrument and any licence stay with your study documents.
Yes. The data model is the same: verified use, self-reported use, daily check-ins, retention and safety. Endpoints differ by substance, so set them from your protocol and the relevant regulator guidance.
Through role-based access with PII segregation, a field-level audit trail and EU or US hosting. Whether laws such as 42 CFR Part 2 apply is for your counsel; the software provides the technical controls.
Yes. Check-ins open from a secure link in the phone browser with reminders and a completion window; no app is required.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, with site-level numbering, a site coordinator portal and by-site exports.
The sandbox is free with every feature, no credit card and no time limit. You pay only once you go live with real participants. Pricing is not published on the site, so ask for terms for your study.
Keep exploring
EDC for smoking cessation trials
The tobacco-specific design.
ePRO compliance and completion rates
Keeping daily check-ins going.
Adverse event reporting software
Overdose and serious events.
Laboratory eCRF template
Layout for screen results.
Digital intervention pilot RCTs
App-based recovery tools.
Pricing
Free sandbox, pay at go-live.
Free sandbox with every feature. No credit card, and you pay only when you go live.