To what type of trials does ICH GCP apply?

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Multiple Choice

To what type of trials does ICH GCP apply?

Interventional clinical trials of investigational products intended for regulatory submission. ICH GCP sets the ethical and scientific standards for trials that involve human subjects and test an investigational product with the aim of obtaining regulatory approval. It covers how such trials should be designed, conducted, recorded, and reported to protect participants and ensure reliable data. This includes aspects like informed consent, risk–benefit assessment, data integrity, and monitoring. It does not apply to preclinical animal studies, observational or non-interventional studies, or non-interventional post-market surveillance, which follow different guidelines and regulatory requirements.

Interventional clinical trials of investigational products intended for regulatory submission. ICH GCP sets the ethical and scientific standards for trials that involve human subjects and test an investigational product with the aim of obtaining regulatory approval. It covers how such trials should be designed, conducted, recorded, and reported to protect participants and ensure reliable data. This includes aspects like informed consent, risk–benefit assessment, data integrity, and monitoring. It does not apply to preclinical animal studies, observational or non-interventional studies, or non-interventional post-market surveillance, which follow different guidelines and regulatory requirements.

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