ICH E6 R3 Appendices

Journey with an expedition team to the far corners of clinical research, where you’ll discover the critical documents that serve as the map, compass, and logbook for a successful trial. You’ll be immersed in the world of ICH E6 (R3)’s Appendices and how Essential Records collectively support the integrity and ethics of your journey. You’ll gain a keen understanding of your expedition’s blueprint – the clinical trial protocol, along with the Investigator’s Brochure, other essential records that populate a trial’s lifecycle, and the Good Documentation Practices (GDP) that govern them and ensure that every discovery is properly recorded. The result of this adventure will be your increased confidence that your trial is documented with precision, participants are protected, and every finding is trustworthy.