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CTMS Module 9 of 29

EDC & Data Capture

Electronic data capture with form builder, field validation, and real-time review.

Module Overview

The EDC & Data Capture module provides a full electronic data capture system with a visual form builder, field-level validation, edit checks, and real-time data review. CRFs are designed per protocol requirements with automated skip logic, range checks, and cross-form consistency validation.

Key Features

Visual CRF form builder with drag-and-drop fields
Field-level validation with range, format, and required checks
Automated edit checks and cross-form consistency rules
Skip logic and conditional field display
Real-time data entry with auto-save
Query management with source data verification

Workflow & Interface

Explore the module's workflow through interactive interface mockups showing each step of the process.

1

CRF Form Builder

Design electronic case report forms with a visual drag-and-drop builder supporting multiple field types.

medifirm-ctms — module view
Demography (DM)
Screening/Baseline
12 fields defined
3 conditional rules
5 validation rules
8 of 12
Published — v1.2
94.2%
2

Data Entry & Query Management

Real-time data entry with automatic validation. Queries generated for missing, out-of-range, or inconsistent data.

medifirm-ctms — module view

DM — SUBJ-005

Site A — Complete

Verified

AE — SUBJ-005

Site A — Query Open

Query

VS — SUBJ-008

Site B — In Progress

Draft

LB — SUBJ-010

Site C — Out of Range

Edit Check

IE — SUBJ-012

Site D — Complete

Verified
3

Data Quality Overview

Monitor data entry progress, query resolution rates, and SDV coverage across all sites.

medifirm-ctms — module view

Forms Completed

8,432

94.2% completion

Open Queries

234

-15% this week

SDV Coverage

78%

Target: 80%

Edit Check Pass

96.8%

Above 95% target

Module Connections

How EDC & Data Capture integrates with other CTMS modules in the platform.

BidirectionalSubject Management

Visit data captured per subject visit

View Module
Sends toStats Analytics Dashboard

Live data feeds into analytics

View Module
Sends toCentral Monitoring

Data quality metrics drive monitoring alerts

View Module
Receives fromStudy Management

CRF design aligned with protocol

View Module
BidirectionalAPI Integration Hub

External lab and EHR data integration

View Module