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CTMS Implementation Checklist: Kickstart Your CTMS Strategy

Use this checklist to establish a high-level plan with CTMS requirements, implementation timelines, user expectations, and training needs – aligning your team on how a CTMS fits into your processes and enhances efficiency.

Implementing a clinical trial management system (CTMS) requires intensive planning and coordination. This checklist breaks down the key steps and considerations to help you prioritize tasks, streamline global study management, and ensure nothing falls through the cracks.

Checklist Overview

Establish a clearly defined set of high-level CTMS requirements.

Enlist subject matter experts.

Define a clear implementation strategy for your organization.

Establish training and documentation expectations.

Establish High-Level CTMS Requirements

Define what information and standardized templates your team will use during site visits to ensure consistency and efficiency.

Determine the key metrics and KPIs for CTMS reports, and decide how data should be presented for quick, informed decision-making.

Plan for any new or updated SOPs and process guides needed when adopting the CTMS, to maintain quality and integrity in trial operations.

Identify your end-users and their needs. Decide on role-based access levels, mobile app necessity, and ensure the CTMS meets user expectations to drive adoption and productivity.

Outline relevant regulations (e.g., 21 CFR Part 11, GDPR) that the CTMS must comply with, so you can safeguard compliance and your organization’s reputation from day one.