Healthy volunteers do not have a disease to monitor, so the study rests on screening quality, tight safety checks and a clean record of every dose. Capture handles consent, screening, dosing-day assessments and follow-up in one EDC with an audit trail. Build it free in the sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Pre-screening
Short eligibility questions before the visit
Consent
Signed and countersigned before any procedure
Screening visit
History, vitals, ECG, labs, registry check recorded
Dosing day
Pre-dose checks, dose record, post-dose safety
Confinement and sampling
Vitals, ECG, adverse events by timepoint
Follow-up
End-of-study visit and safety call
What a healthy volunteer study needs from its EDC
The study type
Healthy volunteer studies are most often early-phase: first-in-human single and multiple ascending dose studies, food-effect and drug-interaction studies, bioavailability work and thorough QT studies. Volunteers receive a product without an expected personal benefit, so the ethical weight falls on screening, consent, safety monitoring and fair compensation. The data profile follows: lots of vitals, ECGs and laboratory values at defined timepoints, rich adverse event reporting, and relatively few clinical endpoints in the sense a disease trial has them.
Because healthy people are screened rather than diagnosed, eligibility is a long checklist of ranges. Age, body mass index, blood pressure, ECG intervals, liver and kidney tests, smoking status, prior medications and recent participation in other studies all matter. Capture calculates BMI, QTc (Bazett and Fridericia), eGFR (CKD-EPI 2021) and age from date of birth as read-only fields during entry, and edit checks can raise a query when a value falls outside the range in the protocol. The investigator makes the eligibility decision; the form shows which criterion a result affects. Start from the eligibility screening template, vital signs template and lab results template.
The other recurring problem is overlap between studies. Some volunteers take part in studies at several units, and a too-short gap or an overlap can affect safety and data validity. In the UK, the Health Research Authority runs a database called TOPS that units check at screening, and some other countries run volunteer registries too. Whatever your national model, record the check in the volunteer’s file: which register or procedure was used, the date, and the result. A field and a required date are enough to make the step visible to a monitor. Capture does not connect to such registries.
Healthy volunteer work shares tooling with other early-phase studies. The EDC for Phase 1 trials page covers dose escalation records and safety review, first-in-human studies goes further on cohort-level decisions, and best EDC systems for Phase 1 trials compares what to look for.
Calculated values
Age
AGEBMI
BMIResting systolic BP
SYSBPAbove protocol range, confirm repeat reading
QTcF
QTCFParticipation check done
PRTCHKDate of participation check
PRTCHKDTProtocol to build
| Study element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Pre-screening | Short questions before a visit | Short eligibility form; links with QR code enrollment |
| Informed consent | Signed, countersigned, with version and timestamps | eConsent; basic clinical trial consent template |
| Screening assessments | History, vitals, ECG, laboratory, BMI, eGFR | Medical history, vitals, labs, physical exam |
| Randomization and cohorts | Assignment to active or placebo, cohort number | Randomization in the same platform; blinded roles never receive arm values |
| Dose record | Product, dose, date and time, who administered | Per-day eCRF form |
| Safety | Adverse events, concomitant medications, abnormal results | Adverse event form, concomitant medications |
| Follow-up | End-of-study visit, safety call | Follow-up visit form with visit window |
Compensation and payment records are outside Capture. Keep them in your finance and site files.
Build the screening, dosing and follow-up forms in the free sandbox, enter a few practice volunteers and see how out-of-range values are flagged. Every feature, no credit card.
Consent and safety
Volunteers are free to decline or leave at any time, and the consent process has to show it. eConsent lets the volunteer read, confirm a one-time email code, and sign on screen; the staff member countersigns with password re-authentication, and the signed PDF includes the signature data and audit trail. Consent can be completed before the screening visit, so the volunteer arrives having already had time to read and ask questions. Informed consent text is yours to write; the informed consent form generator is a start.
Adverse events are the central output. Each event is captured with onset and resolution times, severity, seriousness, relationship to the product and action taken, and serious events follow their own form. In a dose-escalation study, the safety review committee needs a current view across the cohort, which the by-visit exports and the audit trail provide; the decision to escalate stays with the people charged to make it. The adverse event reporting page and the SAE deadline calculator help with planning the process.
Many volunteer studies are placebo-controlled and blinded. Capture includes randomization, and blinded roles never receive treatment-arm values; this is enforced by masked database views and row-level security, not just by hiding fields. The randomization software page explains the options, and stratified randomization is available if your design uses cohorts or sites as strata.
Build sequence
Turn each inclusion and exclusion rule into a field and, where it is numeric, an edit check range.
Upload the protocol for an AI draft of visits and forms. Review before anything is saved.
Pre-dose checks, dose record and post-dose observations by timepoint, with calculated fields for QTc and time since dose.
Run a full cohort in the sandbox, including a screen fail, a withdrawal and a serious adverse event.
Approve the forms, which locks them, then start the paid live phase when real volunteers are consented.
Before the first volunteer
Each numeric criterion has an edit check and a named reviewer.
Which register or procedure, what exclusion period applies, and where the result is recorded.
Medical cover, unblinding and escalation steps in the study documents.
The ethics-approved text is the version in the system.
Dictionary and dataset opened by the statistician.
No. Capture does not connect to external registries. You can record that the check was done, the date and the result as fields on the screening form, so a monitor can see the step.
Yes. BMI, QTc (Bazett and Fridericia), eGFR and age from date of birth are calculated read-only fields. Edit checks flag values outside the protocol range, and the investigator decides on eligibility.
Yes. Randomization and eCRF are in the same platform, and blinded roles never receive treatment-arm values.
Yes. Capture covers Phase 1 through Phase 3 and you can build and test early-phase studies in the free sandbox before paying to go live.
Capture provides 21 CFR Part 11-aligned controls: field-level audit trail, electronic signatures and role-based access. Compliance is shared with your validated use of the system.
Build and rehearse your study in the free sandbox. No credit card, and you pay only when real volunteers are enrolled.