Question: Goals of ICH

Answer: To standardize technical guidelines and requirements for drug marketing registrations, so that applications for marketing to various regulatory agencies around the world can occur without redundant testing

Question: ICH E6 has become

Answer: The international standard for the design, conduct, monitoring, and reporting of clinical research of investigational drugs

Question: Good Clinical Practice (GCP)

Answer: enhances protection of study subjects and the integrity of the data collected during a trial.

Question: Legally Authorized Representative (LAR)

Answer: an individual, or judicial or other body, authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the research

Question: Protocol Deviation (or Violation)

Answer: an unplanned excursion from the requirements of the protocol that is not implemented or intended as a systematic change.

Question: CH membership includes which five (5) regulators?

Answer: Health Canada

European Commission EU

Ministry of Health Labor & Welfare

Pharmaceuticals &Medical device agency (PDMA from Japan)

Swissmedic

FDA

Question: When does the ICH E6 guideline apply?

Answer: several countries adopted it as law. In the U.S., however, the FDA adopted the ICH E6 only as guidance

Question: FDA adopted the ICH E6 only as guidance (HHS and FDA 1997) True or False

Answer: True: ICH guidelines do not have the force of law in the U.S. and are not regulations

Question: Advantages of complying with ICH E6

Answer: Studies conducted in accordance with ICH E6 to meet the regulatory requirements of the drug approval processes for all of these countries.

Question: (4) main categories of ICH guidelines

Answer: Quality, Safety, Efficacy, Multidisciplinary