Good Clinical Practice (GCP)

GCP

Regulatory

International ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Protects trial subjects' rights and ensures data integrity.

Ejemplos

ICH E6(R2)
Informed consent requirements
IRB/Ethics committee oversight

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International ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Protects trial subjects' rights and ensures data integrity.