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• name: description content: 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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• Appendix A. INVESTIGATOR’S BROCHURE
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• Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
• GLOSSARY
• https://ichgcp.net/news/applying-for-a-paediatric-investigation-plan-pip-review-of-the-ema-guidelines
• https://ichgcp.net/news/considerations-for-the-use-of-real-world-data-and-real-world-evidence-to-support-regulatory-decision-making-for-drug-and-biological-products
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• GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer
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• A Study to Evaluate D-2570 in Participants With Moderate to Severe Plaque Psoriasis (N/Z)
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