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ICH GCP E6(R2) Section5.5.3.hCriticaltoQuality Questions do you ensure data integrity including data describing context, content and structure when making changes to the computerized systems, software

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What is ich gcp?

ICH GCP stands for International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Good Clinical Practice. It is a guideline for the conduct of clinical trials involving human subjects.

Who is required to file ich gcp?

Sponsors, researchers, and investigators involved in clinical trials are required to comply with ICH GCP guidelines.

How to fill out ich gcp?

ICH GCP guidelines provide detailed instructions on how to conduct and document clinical trials in a compliant manner.

What is the purpose of ich gcp?

The purpose of ICH GCP is to ensure the rights, safety, and well-being of trial subjects are protected, and that the clinical trial data is credible and reliable.

What information must be reported on ich gcp?

ICH GCP requires reporting of all trial-related information, including adverse events, protocol deviations, and study outcomes.

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