Definition

Original records or certified copies containing raw data and observations about an adverse event, such as medical records, lab reports, emails, or call recordings.

Example

A hospital discharge summary documenting a patient's adverse reaction is a source document. The ICSR derived from it should accurately reflect the source information.

Regulatory source

ICH E6 (GCP), 21 CFR Part 11

Common mistakes

Discarding original emails or call notes after entering data into the safety database. Source documents must be retained.

Inspector question

Show me the source documents for this case. How do you ensure traceability between the database entry and original sources?

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