Hot Topics from ACDM
Hot Topic: How RBM impacts Clinical data management and Clinical Data Manager?
|Date:||September 6, 2019|
|Session Lead:||Valerie Cotonnec|
|Locatione:||Online 12:00 – 13:00 UK Time|
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:
|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
|Price (Member)||£0 (+VAT)|
|Price (Non-Member)||£50 (+VAT)|
|Link for Booking:||click here|
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