Implementing a clinical data management randomization system aimed to satisfy research regulations

Authors

• MJ Duvenhage
• Y Cai
• L Goldfeder
• L Dodd
• J Xiao
• K Newell
• C Whalen
• A Rosenthal
• M Tartakovsky

Abstract

The Office of Cyber Infrastructure and Computational Biology at the National Institute of Allergy and Infectious Diseases (NIH) has developed a fixed randomization solution (sequential allocation, also allowing stratification) integrated with their clinical data management system (CDMS) that complies with regulatory requirements while leveraging the benefits offered by IVRS/IWRS (Interactive Voice/Web Response Systems). The solution maps to the established randomization process and runs within the workflows of the CDMS itself and providing participant randomization based on inclusion and protocol criteria. The solution plans to map the digital process of randomization to the regulatory framework such as GCP and 21 CFR Part 11, and will further include user authentication, audit trails, and reporting tools. The solution aims to accommodate the collection of randomization data as part of the CDMS ensuring that the workflow is contained within the same system. It thereby simplifies the randomization process, reducing interfaces between multiple system and ensuring a more streamlined validated data flow. The presentation will consider risks such as 1) ensuring that the randomization tables are sufficiently protected against unintended user access, 2) technology is sufficiently tested before implementation, 3) change control testing, and 4) ensuring the solution meets the regulatory requirements.

Scientific Focus Area: Research Support Services

This page was last updated on Friday, March 26, 2021