Clinical Research Knowledge Quiz

The purpose of ICH is to bring together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop guidelines.

The responsibilities of a clinical research sponsor include providing guidelines, overseeing the conduct of the study, ensuring compliance with regulations, and providing financial support for the research.

The different types of ICH guidelines mentioned in the text are QUALITY (Q), SAFETY (S), and EFFICACY (E).

<p>The topics covered under the overview of ICH GCP include the definition, objective, and importance of GCP, different types of ICH guidelines, GCP standard rules, principles of ICH-GCP, ICH GCP E6 (R1) &amp; (R2), sponsor, investigator, and IRB responsibilities/guidelines, clinical protocol &amp; amendments, and investigator’s brochure.</p> Signup and view all the answers

<p>The ICH topics are divided into the four categories: QUALITY (Q), SAFETY (S), EFFICACY (E), and MULTIDISCIPLINARY (M).</p> Signup and view all the answers