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Systems
CRF Studio
CRF Studio
Protocol:
Phase III Oncology Solid Tumor (RECIST 1.1) (ONC-2026-003)
Pivotal Medical Device IDE Trial (ISO 14155 / TAVR) (DEV-2026-VALVE)
Digital Health & Safety (PRO-CTCAE, PHQ-9, ECG QTc, SAE) (INST-VAL-007)
Phase II CNS / Alzheimer's Cognitive Trial (NEURO-2026-401)
Phase I First-in-Human PK Dose Escalation (PK-2026-101)
Blank Starter Canvas (CUSTOM-2026-001)
Oncology
Phase III
Verified
Branding
Docx / PDF
+ CDASH Form
Share
How It Works
Form Designer
Designer
1
Visit Matrix (SoA)
Matrix (SoA)
2
Logic & AST Rules
AST Rules
3
Live 21 CFR EDC
Live EDC
4
Annotated aCRF
aCRF Viewer
5
CDISC / Exports
Exports
6
Layout Canvas
12-Column Responsive Grid
Desktop
Tablet
ePRO Mobile
Add Section
+ Section
DM
Demographics & Informed Consent
Subject baseline characteristics, demographics, and consent tracking
§1.
Informed Consent
2 fields
ICDAT
date
-
6/12
+
3c
6c
12c
* Req
Date Informed Consent Signed
*
SDTM: DS.DSSTDTC [DSDECOD=INFORMED CONSENT OBTAINED]
Core: R
ICYN
radio
-
6/12
+
3c
6c
12c
* Req
Did subject provide written consent prior to any protocol procedures?
*
No
Yes
§2.
Baseline Demographics
5 fields
BRTHYR
integer
-
4/12
+
3c
6c
12c
* Req
Year of Birth (YYYY)
*
SDTM: DM.BRTHYR
Core: HR
AGE
integer
-
4/12
+
3c
6c
12c
* Req
Age at Screening
*
Years
SDTM: DM.AGE
Core: HR
SEX
single_select
-
4/12
+
3c
6c
12c
* Req
Sex assigned at birth
*
-- Select from 4 options --
▼
SDTM: DM.SEX
Core: R
RACE
single_select
-
6/12
+
3c
6c
12c
* Req
Race (Select primary)
*
-- Select from 6 options --
▼
SDTM: DM.RACE
Core: HR
ETHNIC
single_select
-
6/12
+
3c
6c
12c
* Req
Ethnicity
*
-- Select from 4 options --
▼
SDTM: DM.ETHNIC
Core: HR
Add New Section to Form
+ Widget
Layout Canvas
12-Column Responsive Grid
Desktop
Tablet
ePRO Mobile
Add Section
+ Section
DM
Demographics & Informed Consent
Subject baseline characteristics, demographics, and consent tracking
§1.
Informed Consent
2 fields
ICDAT
date
-
6/12
+
3c
6c
12c
* Req
Date Informed Consent Signed
*
SDTM: DS.DSSTDTC [DSDECOD=INFORMED CONSENT OBTAINED]
Core: R
ICYN
radio
-
6/12
+
3c
6c
12c
* Req
Did subject provide written consent prior to any protocol procedures?
*
No
Yes
§2.
Baseline Demographics
5 fields
BRTHYR
integer
-
4/12
+
3c
6c
12c
* Req
Year of Birth (YYYY)
*
SDTM: DM.BRTHYR
Core: HR
AGE
integer
-
4/12
+
3c
6c
12c
* Req
Age at Screening
*
Years
SDTM: DM.AGE
Core: HR
SEX
single_select
-
4/12
+
3c
6c
12c
* Req
Sex assigned at birth
*
-- Select from 4 options --
▼
SDTM: DM.SEX
Core: R
RACE
single_select
-
6/12
+
3c
6c
12c
* Req
Race (Select primary)
*
-- Select from 6 options --
▼
SDTM: DM.RACE
Core: HR
ETHNIC
single_select
-
6/12
+
3c
6c
12c
* Req
Ethnicity
*
-- Select from 4 options --
▼
SDTM: DM.ETHNIC
Core: HR
Add New Section to Form
+ Widget
Forms (6)
Canvas
Inspector
Return to Portfolio
Neuroimaging CAD
NeuroRecon: FreeSurfer Simulator
Interactive 3D Pipeline
Formal Logic Engine
Logical Proof Workspace
Deductive Proof Canvas