Start from the claim you want to make, not from the software. Capture helps you turn a claim into pre-specified endpoints, collect them with diaries and site forms, and keep the record that shows how the evidence was produced.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Endpoint | Collected by | Timepoints | Pre-specified | |
|---|---|---|---|---|
| Claim: "supports restful sleep" | Sleep diary score | Participant, phone | Daily, weeks 0 to 8 | |
| Claim: "supports energy" | Fatigue scale | Participant, phone | Weeks 0, 4, 8 | |
| Safety and tolerability | Adverse event form | Site, eCRF | Every visit | |
| Product use | Adherence log | Participant, phone | Daily |
How this page differs from "EDC for supplement trials"
Why start from the claim
Supplement brands often commission a study after the label is drafted and discover that the measured outcome does not match the sentence on the pack. A claim about "supporting restful sleep" needs an outcome that actually measures sleep; a claim about "energy" needs something other than a single mood question. The cheapest moment to catch a mismatch is on paper, before recruitment, when you map each claim to an endpoint, an instrument and a timepoint.
Regulators and advertising authorities expect claims to be supported by evidence, and what counts as enough differs by market, product and wording. This page does not tell you where that line is. It describes how to run a study so that whatever evidence you generate is traceable: someone reading your data package can see what was planned, what was collected, who changed what and when, and which forms were live. Your regulatory adviser decides what the claim can say; the study design decides whether the evidence exists.
Write the primary and secondary endpoints, the instrument, the timepoints and the analysis plan in the protocol before the first participant. Then build the forms to match. In Capture the forms are drafted, reviewed and approved before use, and approved forms are locked for live use, so the form participants completed is the form you specified.
Stage 1
DraftBuild and edit freely
Stage 2
ApprovedLocked for live use
Stage 3
In the casebookOnly approved forms
SDV requirement changed on Systolic BP
Data manager · Reason: critical safety value
Form approved: Vital Signs (VS) v2
Study owner · Locked for live use
Answer changed: Weight 68.0 to 68.5 kg
Site coordinator · Reason: transcription error
Workflow
Write each draft claim in plain words, with the population it applies to.
Choose an outcome that measures what the claim says, and the instrument and timepoints for it. Pick validated scales where they exist and check each rights holder's licence terms.
Upload the protocol and let the AI draft visits and forms, then review them. Use the protocol template if you are starting from nothing.
Enter sample data, check skip logic and edit checks, and confirm that the export gives your statistician the columns they need.
Approve the forms, collect electronic consent and enrol participants. Participants can use diaries on their own phones with reminders and completion windows.
Resolve queries, export CSV or Excel with the data dictionary and give the file to your biostatistician. The database lock workflow describes the closing steps.
Evidence trail
| Question a reviewer asks | What you show | Capture feature |
|---|---|---|
| Was the endpoint planned in advance? | Protocol, analysis plan and the approved forms | Draft to approved lifecycle; approved forms locked for live use |
| Who entered or changed this value? | Old value, new value, user, time, reason | Field-level audit trail, exportable, not editable in the UI |
| Did participants consent? | Signed consent with timestamp | eConsent with on-screen signature and email OTP |
| Were diaries completed on time? | Compliance by participant and window | Completion windows and compliance dashboard |
| Was the product taken? | Adherence entries | Daily adherence form on the participant's phone |
| Could treatment allocation bias the data? | Blinded roles and randomisation | Blinded roles do not receive treatment-arm values |
| Can the analysis be reproduced? | Exported dataset and codebook | CSV or Excel export with automatic data dictionary |
Build the form, enrol yourself as a test participant and export the data. No credit card.
Design
Control and blinding matter more for subjective outcomes such as sleep, mood or energy, because expectation affects what people report. A randomised, blinded, placebo-controlled design is the usual route; see clinical trial randomization software for how allocation is handled. In Capture, blinded roles never receive treatment-arm values, which is enforced at the database layer, not only in the interface.
Choose outcomes you can collect reliably. Daily diaries on participants' phones give repeated measures with reminders and windows; site forms capture vitals, labs and adverse events. For repeated self-report, patient diary software and ePRO software describe the options. The sleep diary and fatigue log templates show the structure of a short repeated form for your own design.
Record safety even in a wellness study. An adverse event form at each visit documents tolerability, and it protects participants. Sample size also affects whether a result can support anything: use the sample size calculator early and involve a statistician.
Data package
A brand that commissions a claim study usually needs to hand the results to a regulatory adviser, a lawyer or an advertising reviewer, who will ask how the numbers were produced. Prepare a short package: the protocol and analysis plan, the blank eCRF PDF showing every approved form, the exported dataset with its data dictionary, the statistician's report and the audit trail excerpts relevant to any data corrections. The blank eCRF export has a cover page, a form index and a visit-by-form matrix, which gives a reader a map of what was collected and when.
Resolve data queries before you close the study. Edit checks raise an auto-query when a value breaks a rule, and a monitor or data manager can raise queries manually. A study that closes with open queries invites questions about which values the analysis used. The query management page explains the workflow, and the audit-ready data page describes what a reviewer expects to find.
Be careful what the data package claims. Describe the study and its results as they are, report all pre-specified endpoints including those that did not move, and let the regulatory adviser decide how the wording on the label or in advertising reflects them. A transparent package is the strongest protection for the brand, and it is much easier to produce when the records were kept as the study ran, not reconstructed at the end.
Before you enrol
Each draft claim with its population.
Instrument, timepoints and analysis, pre-specified.
Your adviser confirms what evidence the claim and market require.
Where your design needs it, including consent text.
Only approved forms appear in the casebook.
Columns, codebook and analysis set defined before data arrive.
No. What counts as sufficient evidence depends on the market, product and wording, and your regulatory adviser decides it. Capture helps you run the study and keep the record.
Choosing the outcome after seeing the data weakens credibility. Pre-specifying the endpoint, instrument, timepoints and analysis shows the evidence was planned.
Forms move from draft to approved, and approved forms are locked for live use. Only approved forms appear in the casebook.
Yes. Diaries open in the phone browser through a secure link, with reminders, completion windows and compliance tracking.
Yes. Blinded roles never receive treatment-arm values, which is enforced by masked database views and row-level security.
That page describes the platform for supplement studies in general. This one starts from the claim and shows how to trace it to an endpoint and an evidence trail.
Yes. Export CSV or Excel with an automatic data dictionary, filtered by date range or site.
The sandbox is free with every feature, no credit card and no time limit. You pay only once you go live with real participants.
Keep exploring
EDC for supplement clinical trials
The platform view for supplement studies.
EDC for nutraceutical clinical trials
Nutraceutical study setup.
Clinical trial software for nutrition research
Diet and nutrition designs.
EDC for cosmetic and skincare claims studies
A parallel claims use case.
Patient diary software
Daily outcomes on a phone.
Audit trail software
How changes are recorded.
Free sandbox with every feature. No credit card, pay only when you go live.