If you’ve visited the doctor or a hospital recently, you can’t help but notice how much of your care depends on some form of electronic information exchange. From the prescription your doctor writes ...
Last week, FDA issued the final version of its 2023 revised draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers,” which ...
US regulators have released a new draft guidance document aimed at providing industry with insight on the use of electronic source data in clinical investigations. The guidance, set to be published on ...
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