Protocol-to-study setupUpdated September 26, 2026

Upload your protocol. Get a draft study back

The AI Study Generator reads your protocol and builds the visits, windows and forms it describes. Your team reviews and adjusts the draft, then launches it without waiting on a build vendor.

  • PDF, DOCX or DOC
  • Schedule-only uploads work
  • Every result is an editable draft

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

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

6

protocol sections the AI reads

3

file types: PDF, DOCX, DOC

100%

of the output is an editable draft

0

build vendors or programmers needed

Input

What the AI reads from your protocol

The AI Study Generator looks for the sections that define a study build. The schedule of assessments is the minimum it needs; everything else adds detail.

  • Synopsis: name, protocol number, therapeutic area, enrolment and duration.
  • Schedule of assessments: visit columns, timing and windows.
  • Assessments and procedures: the form content behind each row.
  • Eligibility criteria: screening form fields.
  • PRO section: diary instruments, frequency and run mode.
  • Study drug section: dispensing visits and accountability setup.

protocol_v3.pdf

  • Synopsis
  • Schedule of assessments
  • Assessments
  • Eligibility criteria
  • PRO section
  • Study drug

Draft study

  • Study details
  • Visits and windows
  • CRF content
  • Screening form
  • Diaries
  • Dispensing setup

Output

A draft you can review line by line

The result lands in the study builder as ordinary visits and forms. Open any visit to check its anchor and window, and any form to refine its questions. Nothing is locked in by the AI.

  • Visits with day, week or month offsets and windows.
  • Draft forms attached to the right visits in the schedule matrix.
  • Diary schedules and dispensing visits when the protocol describes them.
Edit visit · Week 4

Anchor

Milestone (e.g. Randomization)
  • Screening date
  • Milestone (e.g. Randomization)
  • An earlier visit's date
  • Fixed study day
  • A form field date

Offset

4Weeks

Window

-3 d/+3 d

Epoch

Treatment

Visit location

On-siteRemoteHomeHybrid

Control

Share only what you want to share

You do not have to upload the full protocol. A schedule of assessments on its own is enough to build the visit skeleton, and you can add forms from the template library afterwards.

  • Upload the full protocol for the most complete draft.
  • Or upload just the schedule and build forms from templates.
  • Or describe the study in a few sentences instead of uploading anything.
app.capture.study · New study
Capture AI Study Generator: describe the study or upload a protocol to generate it

See what Capture builds from your protocol

Upload it to a free sandbox. You review everything before a participant ever sees it.

Upload a protocol free

Launch

From draft to launch with checks at every step

Once the draft is right, approve the forms, activate your sites and launch. Capture shows what is still outstanding instead of letting a half-finished study go live.

  • Forms move from draft to approved before sites can use them.
  • Sites are activated through a short checklist.
  • A readiness list shows what still needs attention.
See the full study builder
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

The difference

Manual study start-up vs protocol-to-study in Capture

First step
Write a build specification from the protocol
Upload the protocol and get a draft study
Visit schedule
Re-keyed from the schedule of assessments
Generated with offsets and windows
Forms
Designed from scratch by a programmer
Drafted and attached to visits, ready to refine
Review
Rounds of specification sign-off
Click through the draft study itself

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

How does protocol-to-study setup work?

You upload the protocol and the AI Study Generator reads its schedule of assessments and related sections. It creates draft visits, windows and forms in the study builder, which your team then reviews and adjusts.

Which file formats are supported?

PDF, DOCX and DOC. Spreadsheets and images are not supported for protocol upload yet.

What is the minimum I need to upload?

The schedule of assessments and the assessment list: visit names, day or week offsets, windows and which assessments happen at each visit. A schedule-only upload is enough for the visit skeleton.

Is the generated study final?

No. Everything the AI creates is an editable draft. Forms still go through approval before sites can use them, and you can change any visit or form.

Can I start without a protocol?

Yes. Describe the study in plain language, or start from the standard Phase 1 schedule and edit it.

Does it set up ePRO diaries and drug dispensing?

When the protocol describes them, the generator reads the PRO section for diary instruments and frequency, and the study drug section for dispensing visits and accountability setup.

How long does setup take?

The draft is generated in minutes. How long the review takes depends on the study, but your team starts from a structured draft instead of a specification document.

Can I try it with my own protocol?

Yes. Upload it to a free sandbox account. No credit card is needed.

Turn your protocol into a study today

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

Upload a protocol free