Print  Close

Recent Regulatory Guidance Trends for Randomization Monitoring in Clinical Trials

Abstract Number:

1780 

Submission Type:

Contributed Abstract 

Contributed Abstract Type:

Poster 

Participants:

Jennifer Ross (1), Kevin Venner (1), Noelle Sassany (1), Brian Stella (2)

Institutions:

(1) Almac Group, N/A, (2) Almac, Souderton, PA

Co-Author(s):

Kevin Venner  
Almac Group
Noelle Sassany  
Almac Group
Brian Stella  
Almac

First Author:

Jennifer Ross  
Almac Group

Presenting Author:

Jennifer Ross  
Almac Group

Abstract Text:

Monitoring is a process to ensure that data integrity is maintained across the duration of a clinical trial. Regulatory authorities recommend that Sponsors focus monitoring strategies on data critical to reliability of trial results. As Randomization is considered critical data, recent regulatory guidance (ICH, MHRA, FDA, EMA) places higher focus on Randomization Monitoring. This type of monitoring concentrates on reviewing accumulated randomization data to confirm that randomization has occurred per protocol/relevant specifications. Randomization monitoring is important in every clinical trial to provide verifiable evidence proving the randomization's integrity. It becomes even more crucial in complex innovative designs (e.g., Master Protocols, trials with AI-enabled devices/machine learning) due to their complexity/novelty. This presentation will establish the importance of randomization monitoring (both in standard and complex/novel protocol designs) and summarize regulatory requirements for randomization monitoring (e.g., sponsors' responsibilities, contents of monitoring plans/reports). It will also present guidance for developing an effective randomization monitoring process.

Keywords:

Randomization Monitoring|Clinical Trial Monitoring|Randomization|Regulatory Guidance Review| |

Sponsors:

Biopharmaceutical Section

Tracks:

Trial Monitoring

Can this be considered for alternate subtype?

Yes

Are you interested in volunteering to serve as a session chair?

Yes

I have read and understand that JSM participants must abide by the Participant Guidelines.

Yes

I understand that JSM participants must register and pay the appropriate registration fee by June 3, 2025. The registration fee is non-refundable.

I understand