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CTMS Module 23 of 29

Document Approvals

Structured review and approval workflows with e-signatures and version control.

Module Overview

The Document Approvals module manages structured document review and approval workflows with multi-reviewer support, e-signatures, version control, and full audit trails. It ensures all critical study documents — protocols, SAPs, ICFs, investigator brochures — go through formal review and approval before distribution.

Key Features

Multi-reviewer approval workflows with parallel and sequential review
21 CFR Part 11 compliant e-signatures
Document version control with full revision history
Review comment tracking and resolution
Approval delegation and escalation
Document distribution tracking and acknowledgment

Workflow & Interface

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

1

Document Review Queue

Reviewers see documents awaiting their approval with priority, deadline, and review context.

medifirm-ctms — module view

Protocol Amendment v3.0

Medical Reviewer

Urgent — 2 days left

SAP v2.1

Biostatistics Review

In Review

ICF v4.2 — Site A

IRB Submission

Approved

IB v5.0

Regulatory Review

Pending

Monitoring Plan v1.3

QA Review

Comments
2

Approval Workflow Tracker

Track documents through multi-step approval chains with current reviewer, comments, and status.

medifirm-ctms — module view

Draft Created

Author Review

Medical Review

Regulatory Review

Sponsor Approval

E-Signature

Distributed

3

Document Approval Dashboard

Overview of all documents in approval pipeline with aging, bottlenecks, and completion metrics.

medifirm-ctms — module view

Pending Approvals

23

4 urgent

Mean Approval Time

6.2 days

Within 10-day SLA

Approval Rate

94%

First-time approval

E-Signatures (30d)

142

21 CFR Part 11 compliant

Module Connections

How Document Approvals integrates with other CTMS modules in the platform.

BidirectionalStudy Management

Protocol and amendments require approval

View Module
BidirectionalStatistical Analysis Plans

SAP requires formal approval

View Module
BidirectionalConfigurable Workflows

Approval workflows configured here

View Module
Sends toRegulatory Vault

Approved documents stored in vault

View Module
Sends toInspection Readiness

Approved documents tracked for readiness

View Module