UK Warns Against Printing Out EHRs For Clinical Trial Monitors
MHRA Has Confidentiality Concerns, Offers Short-Term Fix
New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.
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The UK Department of Health is looking at ways to further improve two “model agreements” that are presently used as standard templates for industry-sponsored clinical trials in government hospitals1.
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.