This week Silvia Palá Intérpretes coordinated interpreting services for the FDA in an audit on good clinical practices, although we have experience in GMP, GLP, GDP and GCP.
How do we prepare?
1) We familiarise ourselves with the audited drug by reading the protocol in English.
2) We also familiarise ourselves with the audited drug by reading the Spanish protocol.
3) We compare both versions and elaborate a bilingual glossary.
4) We assist the auditor in the review of the documentation and interviews with the personnel involved.
