Week 11: Good Clinical Practice - Part 2 question n answers graded A+ 2023/2024

Week 11: Good Clinical Practice - Part 2I.C.H-GCP - correct answer International Conference on Harmonization - Good Clinical Practice Initiation of I.C.H - correct answer Launched in 1990s ; Undertakings that brings together the drug regulatory authorities and the pharmaceutical industry ; Europe, Japan and US Good Clinical Practice (GCP) - correct answer Rules of conducting good, hygienic and ethical research because of unethical and unsafe treatment of human rights; laws came from USA and UK Harmonise GCPs - correct answer Standardise the conduct of clinical trials so that data could be universally accepted; improve public health and make most efficient use of human, animal and material resources I.C.H QSEM guidelines - correct answer Q- Quality S- Safety E- Efficacy M- Multidisciplinary I.C.H rules of conduct - correct answer Chapter 3: IRB/EC (international review board/ ethics committee) Chapter 4: Investigator's responsibilities Chapter 5: Sponsor's responsibilities Chapter 6: Trial Protocol Chapter 7: Investigator's brochure Chapter 8: Essential documents I.C.H legislation objectives - correct answer 1. Ensure that trials of new products in humans are performed so as to ensure that least amount of harm to participants 2. Ensure the safety and efficacy of the product is adequately demonstrated