Part 1 - Preparing for a Risk-Based Future: What ICH Revisions Mean for Clinical Trial Design and Conduct
In a two-part series, this first paper outlines the quality and regulatory thinking that underpins RBQM, and details essential points of compliance for emerging ICH core guidances on RBQM—including ICH E8 (R1) and ICH GCP E6 (R3)—and offers further discussion of RBQM implications for sponsors, clinical sites and patients.n a two-part series, this first paper outlines the quality and regulatory thinking that underpins RBQM, and details essential points of compliance for emerging ICH core guidances on RBQM—including ICH E8 (R1) and ICH GCP E6 (R3)—and offers further discussion of RBQM implications for sponsors, clinical sites and patients. n a two-part series, this first paper outlines the quality and regulatory thinking that underpins RBQM, and details essential points of compliance for emerging ICH core guidances on RBQM—including ICH E8 (R1) and ICH GCP E6 (R3)—and offers further discussion of RBQM implications for sponsors, clinical sites and patients.