52: Understanding Regulatory Expectations for the Data Management of Randomization Schedules

Music City Center 

Regulatory authorities consider the Randomization Schedule as data critical to the integrity of a clinical trial. As cited in several regulatory guidance documents, randomization is a mandatory area evaluated during regulatory reviews, applications and final study reports. Thus, the Data Management for Randomization Schedules must follow robust processes.
For instance, ICH-E9 states that "the randomization schedule itself should be filed securely by the sponsor or an independent party in a manner that ensures that blindness is properly maintained throughout the trial." Further in the recent FDA guidance on AI-enabled devices, it affirms that "data management is also an important means of identifying and mitigating bias." While the randomization schedule data management is imperative for any type of randomized clinical trial, it may be even more critical for trials that examine AI enabled devices due to their novelty.
This presentation will provide best practices for the data management of randomization schedules for all types of randomized trials. It will summarize the relevant regulatory guidance documents and provide illustrations on how to successfully achieve compliance.

Randomization

Randomization Schedules

Randomization Lists

Data Management

Regulatory Guidance Review 

Biopharmaceutical Section