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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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• 2.  INVESTIGATOR 
• 3. SPONSOR
• 4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR
• Appendix A. INVESTIGATOR’S BROCHURE
• Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
• 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
• https://ichgcp.net/news/the-study-of-the-new-investigational-drug-for-acute-myeloid-leukemia-and-myelodysplastic-syndrome
• https://ichgcp.net/news/open-label-study-of-entrectinib-in-ros1-gene-fusion-positive-rare-adult-paediatric-and-teenage-young-adult-tya-cancers
• https://ichgcp.net/news/randomized-double-blind-placebo-controlled-phase-1b-study-of-gsbr-1290-in-adult-overweight-or-obese-healthy-subjects
• https://ichgcp.net/news/a-study-of-dexpramipexole-in-adolescents-and-adults-with-severe-eosinophilic-asthma-exhale-2
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• Breast Cancer PSMA PET
• A Dose-exploration Study of EDP167 in HoFH
• GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer
• NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
• Arthrosemid vs. Steroid for the Management Knee Osteoarthritis
• Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy
• Metabolomic Pathways and Traditional Chinese Medicine Body Constitution in Cancer-related Fatigue
• A Study to Evaluate D-2570 in Participants With Moderate to Severe Plaque Psoriasis (N/Z)
• Functional Impact at 12 Months Post-op of Posterior Cruciate Ligament Conservation During Robotic-assisted Surgery (MAKO) for Total Knee Replacement. (LCPTG)
• IIT2025-03-YANG-LIFT-HCC
• Phase 3 Bunionectomy Study
• At-Home Paracentesis for Women With Cancer-Related Malignant Ascites (Paracentesis) (Paracentesis)
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