ICH Drafts Modernized Principles For E6 Good Clinical Practice Guide
As part of efforts to “renovate” its good clinical practice (GCP) framework, the International Council for Harmonisation has framed new overarching GCP principles that can be applied to diverse trial types and data sources.
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The International Council for Harmonisation has issued updated Good Clinical Practice principles to accommodate new clinical trial and data types.
Guidance on regulatory and data protection considerations for decentralized clinical trials varies widely between the EU and the US. Trial sponsors need to pay particular attention to issues such as missing data, informed consent and data collection, say lawyers from Sidley Austin.
The European Medicines Agency has published a keenly awaited guidance document on how to use computerized systems in clinical trials while ensuring data integrity and patient rights.