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France Consults On Best Practice Guidelines For Decentralized Trials

 
• By Ian Schofield

The CNIL plans to update its data protection methodologies based mostly on the results of a new consultation and the outcome of a pilot in which companies are asked to identify the challenges they have faced when designing trials with decentralized elements.

Patient data
Decentralized trials require new guarantees of patient data protection • Source: Shutterstock

The French data protection agency, the CNIL, has produced three guidelines on the handling of data in decentralized clinical trials in a move to bring its good practices and recommendations into line with EU regulations and advances in health research and technology.

The documents, which cover good practices for remote quality control in decentralized trials, home monitoring arrangements, and electronic provision of information to trial subjects, have been put out for

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