Attachment 1 SOW crosswalk.docx

This document is a compliance crosswalk matrix that maps the government's Statement of Work (SOW) requirements to corresponding sections within an offeror's proposal for RFQ 75D30126Q79181. The crosswalk identifies seven core technical task areas that offerors must address: Core Platform Requirements & 21 CFR Part 11 Compliance, System Initialization/Configuration & User Acceptance Testing (UAT) Execution, API Development & CDC Electronic Data Capture (EDC) Cross-Platform Interfaces, Electronic Master File (eTMF) Storage & Controls, Ad-Hoc System Modifications Handling, FedRAMP Security Baselines & Continuous Monitoring, and Contractor Offboarding & NIST SP 800-88 Data Sanitization. The matrix format requires offerors to provide specific proposal page numbers and paragraph references where each SOW section requirement is addressed, establishing traceability between government requirements and proposed solutions.

This template is designed to ensure systematic compliance verification for the Clinical Trial Management System (CTMS) procurement supporting the CDC's Division of Tuberculosis Elimination. The crosswalk serves as an evaluation tool to confirm that all critical technical, security, regulatory, and operational requirements have been adequately covered in offeror submissions, with particular emphasis on FDA Part 11 electronic records compliance, federal security baselines, data protection standards, and system lifecycle management for clinical trial data management at the TB Trials Consortium.