A device program grows in steps: a handful of early feasibility cases, a larger feasibility or confirmatory phase, then a pivotal study. The data model changes less than the volume does. Capture lets a small team build the first study quickly and carry the form structure forward, with an audit trail on every change.
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months
Few sites, close follow-up
Learn, then lock changes
More sites, more volume
Overlaps enrollment
What a device study asks of its data system
Stages
Regulators and sponsors commonly describe an early feasibility study as a limited clinical investigation of a device early in development, often before the design is final. FDA has published guidance on investigational device exemptions for such studies; the guidance dates from 2013 and has been revised since, so check the current version before you rely on any detail. In practice the study is small, the follow-up is close, and the team expects to learn something that changes the device, the procedure or the protocol.
A pivotal study is the study intended to provide the main clinical evidence for the regulatory decision. It is usually larger, run at more sites, with a locked design, a pre-specified primary endpoint and a statistical analysis plan. The data system matters differently. In early feasibility, flexibility and quick form changes with a record of what changed are the priority. In pivotal, consistency across sites, clean queries and traceable endpoint data are.
It helps to design the first study’s forms with the pivotal study in mind. Keep variable names stable, keep the device and procedure block as its own form, and avoid free-text answers for anything you expect to analyse. Even if the pivotal protocol later adds endpoints, the core demographics, procedure, safety and follow-up forms can carry across. Draft protocols can be turned into visits and forms with the AI study builder, with every proposal reviewed by a person before it is saved, which shortens the first build when the investigational plan is still moving.
Device data
A device case report form differs from a drug form in a few places. Identify the device used, with model and lot or serial where your protocol requires it, and record the procedure date and time, the operator or implanting clinician, the anatomy or site treated, and any intraprocedural events. Performance outcomes may be measured at the time of the procedure (technical success, time to complete) or at follow-up (function, imaging, patient-reported results). Calculated fields help: minutes between two date-times gives procedure duration without a keystroke.
Record the device-related fields on a procedure form and the clinical outcomes on follow-up forms, so that a re-intervention or removal is a dated event and not an edit of the original record. The audit trail then shows when any value was entered or changed, by whom and why. Where a wearable or connected device produces data, Capture supports native connection of a participant’s own account; the wearable device studies page describes the scope, and the medical device clinical trials page covers the general device use case.
Device and procedure
Procedure date
PRDTCDevice model
DVMODELLot or serial number
DVLOTOperator
PROPERProcedure duration
PRDURFrom start and end times
74 min CalculatedTechnical success
PRSUCCNeed to location
| Study need | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and baseline | Anatomy, indication, prior therapy, baseline measures | Screening and baseline eCRF forms with edit checks |
| Procedure and device use | Device model, lot, operator, times, success | Procedure form with calculated duration |
| Adverse events | Term, onset, seriousness, relationship, action, outcome | Adverse event form and SAE report form |
| Device deficiencies | Description, device identifier, whether an event followed, disposition of the device | A separate deficiency form you build, linked by participant and date |
| Follow-up outcomes | Imaging, function tests, patient-reported results | Visit forms with windows, and ePRO tasks on the phone |
| Randomization (if controlled) | Arm allocation, stratification by site | Randomization in the same platform; blinded roles never see arm values |
| Multi-site operation | Site numbering, coordinator access, by-site export | QR enrollment, site-level numbering, site coordinator portal, by-site exports |
Capture supports the sponsor’s data capture. Regulatory classification, IDE or CE-marking route and quality system remain the sponsor’s own responsibility.
Draft the first-cases schedule from your plan, review it, and enter practice cases in the free sandbox before you invite a site.
Safety
Device investigations separate harm to the participant from problems with the device itself. An adverse event is an untoward medical occurrence in a participant, whether or not the device is thought to be the cause. A device deficiency is an inadequacy of the device itself, for example in its quality, reliability, usability or performance, and it may or may not be followed by an event. The two are commonly reported on separate forms because they are routed differently: one to safety review, the other often to product quality and complaint handling.
Build both. The adverse event form should carry onset, seriousness, relationship to the device and to the procedure as separate answers, action taken and outcome. The deficiency form should capture what happened, the device identifier, whether the device was returned and whether an adverse event resulted, with a field linking to the event record. Serious events follow the SAE report form. Reporting clocks come from your regulations and protocol. For example, in a US investigation an investigator reports an unanticipated adverse device effect to the sponsor and reviewing IRB as soon as possible and no later than 10 working days after learning of it; check the regulation text and your own procedures. The SAE deadline calculator helps plan clocks, and the adverse event reporting software page explains the workflow.
The ISO 14155 clinical investigation page describes how data capture supports a sponsor working to that standard. To be clear: Capture does not make a study ISO 14155 or EU MDR compliant on its own. Those obligations sit with the sponsor’s quality system, monitoring, ethics approvals and regulatory submissions. What a data system can do is give you the evidence trail: who entered what, when, what changed and why, who holds which role, and which queries were raised and closed.
Cannot submit yet
Causality is required because the event is serious.
Build sequence
Procedure, safety and follow-up forms plus a deficiency form, kept simple and with stable variable names.
Run a mock implant through follow-up in the sandbox, raise a query, close it, and check the export.
When the device or procedure changes, change the forms deliberately. Forms move through draft and approved states, and approved forms are locked for live use.
Reuse the core forms, add endpoint forms and edit checks, and set visit windows for the follow-up schedule.
Add site coordinator access, site-level numbering and by-site filtering. See multi-site clinical trial management.
Analysis
Device programs usually answer to a biostatistician early, because the endpoint, the performance goal or the comparator needs a justified sample size. The sample size calculator gives a first estimate, and the biostatisticians page describes the exports. CSV and Excel exports include an automatic data dictionary, and CDISC SDTM export produces SAS XPT datasets with Define-XML.
Because each form change and each value change is audited, you can answer the question a reviewer will ask: what did the form look like when this participant was enrolled, and who changed this value afterwards? Treat that as a design requirement for the whole program, not just the pivotal study. The audit-ready data page describes the principles.
No. Capture is a data capture platform. It provides eCRFs, an audit trail, electronic signatures and role-based access that support a sponsor’s own quality system. The sponsor remains responsible for device regulatory compliance, including any investigation standard or regulation that applies.
It can support the data side of a sponsor’s own compliance, with traceable records and access control. It does not satisfy ISO 14155 or MDR on its own, and we do not claim certification against either.
Build a deficiency form beside the adverse event form, with a link between the two. They are different records and are usually routed differently.
Yes. Forms follow a draft to approved lifecycle and approved forms are locked for live use, with the audit trail recording data changes. Plan form changes deliberately.
Yes. Capture is used from Phase 1 through Phase 3 style designs, with site-level numbering, a site coordinator portal and by-site exports for multi-center work.
The sandbox is free with every feature, and you pay once you go live with real participants. See the pricing page.
Keep exploring
EDC for medical device clinical trials
The general device use case.
ISO 14155 clinical investigation software
How data capture supports the standard.
EDC for feasibility studies
Small, fast first studies.
Post-market data capture
Registries and post-market follow-up.
EDC for wearable device studies
Connected device data.
Capture EDC
The EDC product page.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.