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Important factors to consider when working with CRFs

pharmaphorum

They must also comply with regulatory requirements, such as those defined by the FDA. Well-designed forms must: Gather data that’s complete, accurate, and of high quality. Well-designed forms must: Gather data that’s complete, accurate, and of high quality. Be unambiguous and allow for accurate data entry.

article thumbnail

Important factors to consider when working with CRFs

pharmaphorum

They must also comply with regulatory requirements, such as those defined by the FDA. Well-designed forms must: Gather data that’s complete, accurate, and of high quality. Well-designed forms must: Gather data that’s complete, accurate, and of high quality. Be unambiguous and allow for accurate data entry.

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Methodology to Define a Pharma 4.0™ Roadmap

ISPE

™ 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.