EMA Reflection Paper on Expectations for Electronic Source Data & Data Transcribed to Data Collection Tools in Clinical Trials, 8/10

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The European Medicines Agency (EMA) publishes “Reflection Papers” to provide expectations for industry.

The guidance Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials went into effect in August, 2010.ﾠ

This document outlines GCP (good clinical practice) inspectors’ expectations for computer system topics such as validation, SOPs for system use, audit trails, backups, system security, data safeguards, user training, and record archival.