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www.fdanews.com/articles/158938-fda-finalizes-guidance-on-electronic-source-data-in-clinical-trials

FDA Finalizes Guidance on Electronic Source Data in Clinical Trials

September 26, 2013
The FDA has finalized a draft guidance on electronic source data used in clinical trials that it hopes will help streamline research and regulatory submissions for drug and devicemakers. The guidance, Electronic Source Data in Clinical Investigations, outlines protocol requirements when filling in electronic case report forms.
Devices & Diagnostics Letter