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Hot Topics from ACDM

Hot Topic: How RBM impacts Clinical data management and Clinical Data Manager?

Date: September 6, 2019
Type: Hot Topic
Session Lead: Valerie Cotonnec
Locatione: Online 12:00 – 13:00 UK Time
Learning Objectives:

Regulators are encouraging the industry to take a new quality risk management (QRM) approach to clinical trial execution. The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 R2 guidelines provides recommendations on ensuring quality management in clinical trials. A majority of the companies are looking not only to reduce their clinical development risk but also to ensure their data quality is such that it continues to meet the standards expected by regulators. To reduce the risk, companies are paying increasingly more attention to risk management practices and are using risk-based monitoring approaches (RBM).

The Clinical Data Manager has a key role to play in this new process. But what could be this role and what are the impacts of the RBM on the data-management processes?

Please join us to discuss some key topics:

  • How did you implement RBM in your company? (implementation process, strategy)
  • What were/are the main pain points / positive aspects?
  • What are Clinical Data Manager’s inputs in this process?
  • Does the validation of data need to follow a RBM approach too?
  • What are the RBM metrics to follow to ensure the quality of the data?
Who is this suitable for?

ACDM members and non-members who would like to join an open discussion concerning a Hot Topic in Data Management

Outline content
Price (Member)  £0 (+VAT)
Price (Non-Member)  £50 (+VAT)
Link for Booking:  click here

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