Study start-upUpdated September 26, 2026

From protocol to first patient in, without the start-up drag

Build the study from your protocol, hand ethics the documents they need, activate each site against a checklist and launch only when everything is ready. All in the same system your sites will use.

  • Study built from the protocol
  • Ethics documents in one click
  • Site activation checklist

Free sandbox · No credit card · 21 CFR Part 11 aligned

Site 01 · Activation
  • IRB/EC approved12-Aug-2026
  • Contract executedConfirmed
  • Site initiated / SIV completed02-Sep-2026
  • Delegation log completeConfirmed
All 4 items completeActivate site

Pre-launch readiness

1 site activated

1 form not yet approved

Minutes

to a draft study from a protocol

2

blank PDFs for ethics: eCRF and ePRO

4

items on the site activation checklist

1

readiness list before launch

Start-up in four steps

What start-up looks like in Capture

  1. 1

    Build

    Upload the protocol for a draft study, or copy the configuration from a previous study.

  2. 2

    Submit

    Export the blank eCRF and blank ePRO PDFs for your ethics or IRB submission.

  3. 3

    Test

    Create test subjects in bulk to walk through the study before go-live.

  4. 4

    Activate

    Activate each site against its checklist and launch when readiness passes.

Build

A draft study on day one

Upload the protocol and the AI Study Generator drafts the visits, windows and forms. Or copy forms and schedule from a study you have already run.

  • AI Study Generator reads PDF, DOCX or DOC protocols.
  • A standard Phase 1 schedule as a starting point.
  • Configuration export and import between studies.
Protocol-to-study setup
AI Study Generator
phase2_protocol_v4.pdfStep 2 of 3
  • Reading protocol
  • Building visits and windows
  • Drafting forms

11

visits

9

draft forms

2

diaries

Ethics

Ethics documents straight from the build

Blank eCRF and blank ePRO PDFs come from the approved forms themselves, so what ethics reviews is exactly what sites and participants will see.

  • Blank eCRF casebook with form index and visit by form matrix.
  • Blank ePRO in phone layout with skip logic explained.
  • Versioned with an effective date.

Blank eCRF · no subject data

Visit by form matrix

FormSCRD1W2W4W8EOS
DemographicsX
Vital signsXXXXXX
LaboratoryXXX
ECGXX

3. Was the ECG performed?

☐ Yes☐ No

If No, complete question 4.

Protocol CAP-001 · v1.0Page 3 of 24

Sites

Sites ready before they see a participant

Each site passes a short activation checklist before it opens. Team members can be invited at any time, even to a live study, and training acknowledgements are tracked.

  • Ethics approval, contract, initiation visit and delegation log checklist.
  • Delegation log export.
  • SOP training acknowledgement for team members.
  • Study-level site numbers and per-site subject numbering.
  • SO

    Study owner

    Builds and configures the study

  • PI

    Principal investigator

    Oversees the site, signs off the casebook

  • SI

    Sub-investigator

    Enters and signs clinical data

  • SC

    Study coordinator

    Screens subjects, enters visit data

  • CRA

    Monitor (CRA)

    Verifies data, raises queries

  • DM

    Data manager

    Reviews, freezes and locks data

  • PT

    Participant

    Completes their own questionnaires

Start your next study today

Upload a protocol to a free sandbox and walk through start-up end to end.

Start up free

The difference

Traditional start-up vs start-up in Capture

Study build
Weeks of specification and vendor build
A draft from the protocol in minutes
Ethics forms
Screenshots pasted into a document
Blank eCRF and ePRO PDFs from the build
Testing
Test data entered by hand
Test subjects created in bulk
Site go-live
Checklists in email
Activation checklist that gates the site

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

What is study start-up software?

Software that shortens the time from protocol to first participant: building the study, preparing ethics documents, testing and activating sites.

How fast can a study be built?

The AI Study Generator drafts visits and forms from a protocol in minutes. Review time depends on your study.

What do I give the ethics committee?

Blank eCRF and blank ePRO PDFs generated from the approved forms, versioned and dated.

How are sites activated?

Each site completes a four-item checklist: ethics approval, contract, initiation visit and delegation log. Until then no participant can be added there.

Can I reuse a previous study?

Yes. Export a study configuration and import it into a new study as a starting point.

How do we test before go-live?

Create test subjects in bulk and walk them through the schedule and forms.

Can people join after launch?

Yes. New team members can be invited to a live study at any time.

Can I try it?

Yes, in the free sandbox with no credit card.

Get to first patient in sooner

Free sandbox with every feature. No credit card, no sales call.

Start up free