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CTMS Module 3 of 29

Subject Management

Enrollment tracking, subject lifecycle, and safety monitoring across all sites.

Module Overview

The Subject Management module tracks every trial participant from screening through enrollment, treatment, follow-up, and study completion. It manages informed consent, eligibility verification, randomization, visit scheduling, and subject disposition with real-time enrollment dashboards.

Key Features

Subject screening and enrollment tracking
Informed consent management with eConsent support
Eligibility criteria verification
Randomization and treatment assignment
Visit scheduling and completion tracking
Subject disposition tracking (completed, withdrawn, lost to follow-up)
Enrollment velocity dashboards by site and overall

Workflow & Interface

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

1

Screening & Enrollment

Track subjects through the screening process with inclusion/exclusion criteria verification and enrollment decision.

medifirm-ctms — module view

SUBJ-001

Screening — Site A

Eligible

SUBJ-002

Consent Pending — Site A

Pending

SUBJ-003

Randomized — Site B

Enrolled

SUBJ-004

Screen Failed — Site B

Excluded

SUBJ-005

In Treatment — Site C

Active

SUBJ-006

Follow-up — Site C

Active
2

Subject Visit Schedule

Visual timeline of scheduled visits with completion status, missed visits, and protocol-defined windows.

medifirm-ctms — module view

Screening (Day -7)

Baseline (Day 1)

Treatment C1 (Day 8)

Treatment C2 (Day 15)

Treatment C3 (Day 22)

End of Treatment (Day 85)

Follow-up (Day 113)

Study Completion (Day 180)

3

Enrollment Analytics

Real-time enrollment dashboards showing screening-to-enrollment conversion, dropout rates, and enrollment velocity by site.

medifirm-ctms — module view

Total Screened

1,856

across 42 sites

Total Enrolled

1,248

67% conversion

Active in Treatment

892

71% retention

Completed Study

312

25% completed

Module Connections

How Subject Management integrates with other CTMS modules in the platform.

Receives fromStudy Management

Enrollment criteria defined by study protocol

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BidirectionalSite Management

Subjects enrolled at specific sites

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BidirectionalSafety & Pharmacovigilance

Adverse events reported per subject

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BidirectionalEDC & Data Capture

Visit data captured in EDC forms

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Sends toDiversity & Inclusion Metrics

Demographic data feeds diversity analytics

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Receives fromRecruitment Campaigns

Recruitment drives feed screening pipeline

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