Overview

ClinicalDataS is a platform for managing clinical study operations, data capture, and study workflows in one place. After signing in, users land on My Page and move between system-level and study-level areas from a consistent navigation header.

This page introduces platform-wide navigation. For screen-by-screen detail, use the pages linked below.

Key areas after sign-in

Area	What it is for
My Page	Personal home — tasks, current study, and other studies you can open
Study Home	Central hub inside a study — subjects, apps, and the event/CRF matrix
Icon Legend	Reference for icons and status symbols across the platform

Header navigation

Use the header menu at the top of every page to move between key areas:

• Home — Opens My Page
• Administrations — Study and user management (system level)
• System Settings — Platform configuration and security defaults
• All Tasks — Full task list across studies

The user menu in the top-right corner provides profile and session actions for your current role.

New to ClinicalDataS? Start here

If you are setting up a new study for the first time, follow this recommended path:

1. Create a new study — Enter study name, protocol ID, sponsor, and dates.
2. Configure study parameters — Set subject ID format, date format, and event parameters.
3. Create sites — Add participating research sites.
4. Create visit events — Define the visit schedule (Screening, Baseline, Follow-up, etc.).
5. Install apps — Enable the modules needed for your study (Form Builder, Randomization, Rule Studio, etc.).
6. Configure Randomization — Set up blinding, algorithm, and treatment arms.
7. Create Subject Group Classes — Define treatment arm codes for randomization.
8. Add study users — Assign investigators, CRCs, and monitors.
9. Build CRFs in Form Builder — Design data capture forms.
10. Create rules in Rule Studio — Add auto-calculations, validations, and edit checks.
11. Go Live — Transition the study to Production when setup is complete.

Learn more

• My Page — Tasks, current study shortcuts, and switching studies
• Study Home — Navigate inside an open study
• First Study: Create a new study — Step-by-step study creation