Notice ID: 75D301-23-Q-77070
Description
The purpose is to develop a clinical trial monitoring system specifically for intake, analysis, and monitoring of TB clinical trial data.
The contractor shall provide a clinical trial management system to be used by the Tuberculosis Trials Consortium (TBTC). TBTC trial management is currently done through a custom-built system. The objective of the new project is to enhance the current process by creating a system with the capabilities to continue to perform electronic data capture processes as well as additional tasks. The contractor will be responsible for creating a system to manage two TBTC clinical trials (Study 37/ASTERoiD and Study 38/CRUSH). This system must include electronic data capture, monitoring, participant randomization, integrated MedDRA and WHO Drug Dictionary coding, data visualization, data collected in compliance with Clinical Data Acquisition Standards Harmonization (CDASH) and the management of study sites, Institutional Review Board (IRB) data and users. The contractor will provide training to Clinical Research Branch (CRB) staff on the sue of the system. The system is required to be accessible internationally at all TBTC sites while meeting CDC security requirements. This scope of work includes the creation of a trial management system and all labor, materials, and equipment required for system development.
SECTION 4 – TASKS TO BE PERFORMED
Task 1: The Contractor shall prepare a plan for a timeline and provide scheduled status updates for the development of the Trial Management System for two (2) TB clinical research trials (Study 37 and Study 38).
Training plan for CRB staff
Deliver detailed explanation of approach for providing appropriate training to CRB staff
Timeline for development of study 37 management system
Status updates for study 37
- Deliver detailed update on progress via virtual meeting or email, as determined by program
- Deliver email to follow up if in virtual meeting
Task 2: The Contractor shall provide training to Clinical Research Branch (CRB) staff on the use of the system. The Training shall be via virtual meeting. The training shall include all necessary documentation.
Task 3: The Contractor shall provide training to CRB staff to aid in future system builds and modifications. The training shall be via virtual meeting. The training shall include all necessary documentation.
Task 4: The Contractor shall develop a Trial Management System that can be easily accessed by all international sites participating in TBTC studies (Canada, Uganda, Benin, South Africa, Australia, Haiti, and Vietnam). The Trial Management system must comply with international accessibility.
