ichgcp.net

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Title 63 символа
ICH GCP - ICH E6 (R3) Guideline on good clinical practice (GCP)
Description 717 символов
ICH GCP - GOOD CLINICAL PRACTICE (GCP) E6(R3) Step 5. Date for coming into effect 23 July 2025. ICH E6(R3) introduces innovative provisions designed to apply across various types and settings of clinical trials, ensuring continued relevance in the face of ongoing technological and methodological advancements. This guideline provides a new language to facilitate innovations in clinical trial design, technology, and operational approaches. It encourages a risk-based and proportionate approach to conducting clinical trials, promoting fit-for-purpose solutions. It fosters transparency through clinical trial registration and result reporting and offers additional guidance to enhance the informed consent process.​
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Keywords 439 символов
ICH GCP - good clinical practice GOOD CLINICAL PRACTICE (GCP) E6(R3) Step 5 ICH E6(R1) ICH E6(R2) ICH GCP ICH GCP E6(R2) 23 January 2025 Date for coming into effect 23 July 2025 decentralised real-world pragmatic investigator sponsor protocol investigator's brochure trial design safety reporting informed consent statistics ethics committee clinical study/trial report  clinical trials innovation design. ICH GCP
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