Guidance for Industry Electronic Source Data in Clinical Investigations

September 3, 2015
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.2 In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.
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Recommendations on Evidence to Support Equivalence between Electronic and Paper-based Patient-Reported Outcomes
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