📄️ Study Information

Comprehensive end-user guide to updating and modifying existing studies in the Clinical Data System. Learn step-by-step how to configure Study Description, Facility Information, Subject Parameters, Event Settings, and Email Notifications with practical examples and best practices.

🗃️ Study Setup

Set up the study itself: sites, users, roles, events, CRFs, rules, study group classes and dynamic groups.

🗃️ Form Builder

Design case report forms in Form Builder: manage CRFs, build a complete form, reuse the CRF library, generate forms with AI and configure form settings.

🗃️ Rule Studio

Write edit checks and derivations in Rule Studio so data is validated and calculated as it is entered.

🗃️ Randomization Setup

Set up the Randomization app for the study: algorithm, blinding, the event to randomize, eligibility data and notifications.

🗃️ IMP Setup

Configure the IMP (Investigational Medicinal Product) module — settings shared by both Randomization and PSP modes, plus where to find mode-specific configuration.

🗃️ Pre-Screen & eConsent Setup

Configure pre-screening questionnaires and electronic consent forms before subjects are enrolled.

📄️ Queries Setup

Configure pre-defined query descriptions and reason-for-change lists for the Queries app.

📄️ SDV Setup

Configure Source Data Verification (SDV) settings including query and CRF verification rules.

📄️ Medical Coding Setup

Configure the Medical Coding app — set the BioPortal account, dictionary preferences, and auto-code dictionary for your study.

📄️ Monitoring Visit Setup

Configure visit types, report sections, site contacts, site staff, delegation records, site branches, report deadlines and draft report emails for the Monitoring Visit module.

📄️ e-Signature Setup

Understand how to access Signature setup and what is configurable in the current study state.

📄️ CDS Surveys Setup

Configure surveys for your study — link them to screening or enrollment events, assign a CRF, and control how participants access them via public URL or invitation.

📄️ eSource

What eSource means in ClinicalDataS — a study-level data-source designation and an Event Definition type recognized by the platform. There is no dedicated eSource/eTMF application or configuration screen in the current release.

📄️ CDS Mobile App Setup

Configure which study features are accessible via the ClinicalDataS mobile app on Android and iOS.

📄️ AI Hub

Choose which AI capabilities are switched on for a study from the study's AI Hub page.

📄️ Email Templates

Customize the subject and content of the emails a study sends, add a Vietnamese translation, and preview an email before saving.