ICH GCP Quiz Question 1. When did ICH GCP become effective in Europe? Answer: January1997 Question 2. According to the principles of ICH GCP what is the most important consideration when conducting a clinical trial? Answer: protection of trial subjects Question 3. What are the 5 categories of adverse event classified as serious? Answer: Fatal Life-threatening Congenital anomaly Hospitalisation Permanent or significant incapacity Question 4. What is the name of the document, originally drawn up in 1964 which provides a basis for ethical considerations in clinical research? Answer: Declaration of Helsinki Question 5. In which chapter of ICH GCP are essential documents listed? Answer: 8 Question 6. According to ICH GCP for how long should the sponsor and investigator retain records after a study? Answer: 2 years after the last marketing authorisation, 2 years after the last anticipated marketing application in an ICH region, or 2 years after discontinuation of the product. (Or longer if required by local legislation!!) Question 7. What is covered in chapter 6 of ICH GCP? Answer: Protocol and amendments.
Provided by Logic Squared Ltd, www.logic2.co.uk
Question 8. What 3 geographical regions are involved in ICH? Answer: US, Europe and Japan. Question 9. In the ICH GCP Guidelines how many items are listed for inclusion in informed consent? Answer: 20 Question 10. What does the abbreviation ICH stand for? Answer: International Conference on Harmonisation.
Provided by Logic Squared Ltd, www.logic2.co.uk