Introducing Datacapt V5

Your study, built before the kickoff call ends.

V5 is a complete rewrite of our EDC Builder: native CDISC ODM, AI-assisted form design, live preview, study versioning and much more...

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STUDY
Study Design
Assets
Scheduled visits (9)
Common forms
Screening visit (V1, Day -28 to Day -1)
15 forms
Visit information
Informed consent
Demographics
Subject characteristics
Inclusion criteria
Exclusion criteria
Medical history
Vital signs
New form
Randomisation visit (V2, Day 0)
16 forms
Week 4 visit (V3)
9 forms
Week 12 visit (V4)
11 forms
Week 26 visit (V5)
11 forms
Add new event
DATACAPTV5
Screening visit (V1, Day -28 to Day -1)
Demographics
Demographics
Hide variables
Switch to preview
Demographics
8 questions
Save as a template
Collapse all
Date of birth
BRTHDAT
Date of birth
Select month
Age at screening (calculated)
AGE
Sex at birth
SEX
Race (CDISC terminology)
RACE
Ethnicity
ETHNIC
Country of residencee
COUNTRY
Subject initials
SUBJINIT
Question 8
QUEST_HIBIR9
Add question
Item properties
Edit
Conditions
Data validation
Display data
Adv
Date/time
Question title
Date of birth
Description
Your Image
Variable name
BRTHDAT
Question required
Disable future dates
Year and month
Cancel
Save changes
Native CDISC ODMAI-assisted form designLive previewStudy versioningCross-visit edit checksOne row per observation5 export formatsFull audit trailNative CDISC ODMAI-assisted form designLive previewStudy versioningCross-visit edit checksOne row per observation5 export formatsFull audit trail

New structure. Built for modern protocols.

Visits and forms snap into a tree that mirrors how you write protocols: screening, treatment cycles, unscheduled visits.

Study structure
9 events · 22 forms
Common forms
Add new event
Screening visit (V1)
4 forms
Demographics
Informed consent
Medical history
Vital signs
Cycle visit · Day 1
4 forms
Repeats every 4 weeks · ×6
Vital signs
Labs
ECG
Tumor assessment
Unscheduled visit
3 forms
Adverse event visit
Dose modification
Early termination
Common forms, available at every visit
Adverse events · repeating
Concomitant medications · repeating
Common forms, available at every visitAdverse events - repeatingConcomitant medications - repeating

Build your next study on V5.

Book a 30-minute demo and we walk you through the builder on a study like yours.

Book a demo
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Datacapt AI

Describe it. It's built.

Type the protocol in plain words. The AI drafts the eCRF, the visits and the checks, and you review every field.

What are we building today?

Datacapt AI · V5

Build a form once. Reference it across the study.

Save any form as a template and reference it in each visit of the study structure. Edit the template once and every visit follows. Items work the same way: standards-coded, with code lists, units and checks attached.

Form templates
38 templates
New template
Search templates
⌘K
Vital signs
8 items · v3 · published
Referenced in 3 visits
12 studies
Reference
Adverse events
11 items · v5 · repeating
Common form
31 studies
Reference
Demographics
8 items · v2 · published
Screening
27 studies
Reference
Laboratory tests
14 items · v4 · published
Referenced in 2 visits
19 studies
Reference
Quality of life (EQ-5D-5L)
6 items · v1 · draft
Not referenced yet
4 studies
Reference
Build the form once. Reference it in every visit that needs it. Publish a new version and choose which visits follow.
Study structure
DIAB-2026 · 6 visits
Common forms
Add new event
Screening visit (V1)
4 forms
Demographics
Template · v2
Informed consent
Medical history
Vital signs
Template · v3
Week 4 visit (V3)
3 forms
Vital signs
Template · v3
Laboratory tests
Template · v4
Dosing diary
Week 12 visit (V4)
3 forms
Vital signs
Template · v3
Laboratory tests
Template · v4
Quality of life
Vital signs v3 is referenced three times. Edit the template once and each visit follows.
Item library
1,240 items
New item
Search items, variables or SDTM codes
⌘K
All
Vitals
Labs
Adverse events
SDTM-coded
Systolic blood pressure
Number · mmHg · 70–250
VSORRES · SYSBP
VS.SYSBP
14 studies
Add
Weight
Number · kg · 1 decimal
VSORRES · WEIGHT
VS.WEIGHT
22 studies
Add
ECOG performance status
Code list · 0 to 5
QSORRES · ECOG
VS.ECOG
9 studies
Add
Adverse event term
Text · MedDRA coding
AETERM
AE.AETERM
31 studies
Add
Concomitant medication
Text · WHODrug coding
CMTRT
CM.CMTRT
27 studies
Add
Every item keeps its version. Update it once and choose which studies follow.
Add element
QUESTION
Text input
Checkbox
Radio buttons
Date/time
Number value
Rating
File upload
Slider
Calcul
Dropdown
+25 question types
MCP server · Beta

Plug in your own AI.

V5 ships an MCP server. Connect Claude, ChatGPT or your in-house model with one key per user. It reads study metadata and aggregates, writes drafts only, and every call lands in the audit trail with its MCP origin.

MCP session · DIAB-2026 · DRAFT v2
DM
Data manager · Claude Desktop
Build the adverse events form from this schedule of assessments, in draft.
AI
Agent
list_studies1 draft
get_form_structure12 sections
create_item34 fields
create_rule11 edit checks
set_condition6 display rules
write_test_script8 UAT cases
audit trail | origin MCP | j.moreau | 14:02:41
Waiting on your review. Nothing moves to LIVE without it.
Connected clients
Claude Desktopj.moreau
ChatGPTa.benali
In-house modelkey pending
Scopes
✓Read study metadata
✓Read aggregates
✓Write to DRAFT
✕Write to LIVE
✕Patient-level data
One MCP key per userdcp_mcp_•••• 7f2a
Visibility rules
Show if
Sex at birth (SEX)
=
Female
Edit check
Age at screening (AGE)
↔
18
and
75
Edit checks
12 checks
Test on sample data
New check
VS-001
Assessment date before informed consent
VS-002
Weight change above 10% vs previous visit
cross-visit
VS-003
Systolic outside 70–250 mmHg
AE-004
AE start date before first dose
cross-form
CM-005
Medication end date before start date
12 checks compile in one pass before publish
0 errors

Rules you can read out loud.

Compose a check from pills. Cross-form and cross-visit conditions work the same way, with no script to maintain.

Compute any value with one expression.

The new formula builder speaks a real expression language: IF, THEN and ELSE, functions, and variables from any form or visit. Press $ for a variable, # for a function, and the builder validates the expression as you type.

Formula builder
YOUR FORMULA
Valid
( IF ( VS.WEIGHT_PRV - VS.WEIGHT ) > 0 ) THEN == “-1” AND ( IF ( VS.WEIGHT_PRV - VS.WEIGHT ) = 0 ) THEN == “0” ELSE == “+1”
Press $ to reference a variable and # to reference a function
Variables
Functions
Operators
Visit 1
Vital signs
Weight (kg)
VS.WEIGHT
Weight at previous visit
VS.WEIGHT_PRV
Systolic blood pressure (mmHg)
VS.SYSBP
Laboratory tests
Haemoglobin (g/dL)
LB.HGB
Sample date
LB.DAT
Visit 2
VS.WEIGHT_PRV
Weight at previous visit · Number, kg · Vital signs, Visit 1. Derived from VS.WEIGHT of the previous scheduled visit.
Warnings do not block saving
Cancel
Save formula
Derived
BMI
24.2 kg/m²
= VS.WEIGHT / ( DM.HEIGHT / 100 )²
Recalculates on entry, across all visits
Cross-visit
Lowest weight on study
68.4 kg
= MIN ( ALL ( VS.WEIGHT ) )
Reads every visit of the subject
Expression languageCross-visit variablesLive validation
Change log · v1.0 → v2.0
Revision 14
+
Added ECG form to Cycle visit
±
VS.SYSBP edit check range 70–250 → 60–250
−
Removed smoking status from Demographics
+
RECIST 1.1 code list on Tumor assessment
v1.0 · still collecting
v2.0 · published
Coming soon

Amend mid-study. Every change logged.

Publish v2.0 while v1.0 keeps collecting. The change log records who changed what, and when.

A visual builder. See the form the way the site will.

Drag questions into place, set their properties in the side panel and switch to preview at any moment. Desktop and phone, filled with sample data, and every edit shows up as you make it.

Preview · Vital signs · Screening visit
Editor
Preview
Date of assessment
14 / 03 / 2026
Systolic blood pressure
128mmHg
Diastolic blood pressure
84mmHg
Pain intensity · VAS
No painWorst pain
ECOG performance status
0
1
2
3
4
Save and continue
Vital signs · V1
Date of assessment
14 / 03 / 2026
Systolic
128mmHg
Pain intensity
66% complete
Save and continue

Everything you need.

The V5 builder in one place: drag questions, set edit checks and visibility rules, write formulas, reference templates and preview the form as the site sees it.

Drag and drop
Edit checks
Visibility rules
Formulas
Form templates
Live preview

And the rest of the rebuild.

Faster performance engine
Large studies open, edit and publish in a fraction of the time.
5
Export formats
CSV, XLSX, SAS, JSON, PDF
IF DM.SEX = FEMALE
Show/hide logic
Conditional visibility for items, groups and whole forms. No code.
.csv
.xlsx
→ forms
Import from CSV & XLSX
Build forms, items and code lists straight from your spreadsheets.
Aあ
Multi-language forms
Author once, translate in place, deploy everywhere.
DS
DM
PI
Granular roles & permissions
Who designs, reviews and publishes.
New item library
Reusable, standards-coded items you define once and use across studies.
VS.SYSBP
DM.HEIGHT
AE.SEV
Reusable templates
Start from proven study, form and visit templates.
EVENT → FORM → ITEM
New study structure
Maps to how protocols are written.
Study versioning & change log
Amendments mid-study, every change logged.
v1.0
v2.0
Live preview
Desktop and phone, filling with sample data as you build.
EVERY ACTION · EVERY USER
Full audit trail
Every builder action recorded, ready for inspection.

Audit-ready by design.

End-to-end encryption, EU hosting under ISO 27001 & HDS, and a full audit trail on every builder action.

21 CFR Part 11GDPRHIPAAISO 27001HDSGCP