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Both the EMA and FDA have released draft guidance on the issue and are currently soliciting feedback. Increased study adherence: Patients are most familiar with their own devices, and the ability to download an application and complete entries on a device they understand increases their adherence to the study requirements.
™ Roadmap Emmie Heeren AREND JAN WASSINK Venkateshwar Rao Nalluri, PhD Sebastian NIEDERHAUSER 1 May 2023 In the context of data integrity, data flows are essential. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. Published 30 November 2018.
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