Clinical Training with answers graded A+ 2023/2024

Clinical TrainingWhat is Good Clinical Practice (GCP)? - correct answer A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical studies. GCP guidelines provide a framework for the fair, scientifically sound conduct of research studies involving human participants What is the purpose of the ICH GCP guidelines? - correct answer To ensure that the rights, safety, and confidentiality of participants in clinical trials are protected. To ensure that the data collected in clinical trials, as well as the reported results of clinical trials, are accurate and credible. What is the Code of Federal Regulations? - correct answer Official regulations of all federal agencies that are published according to topic in a massive set What is HIPPA? What does it do? - correct answer Health Insurance Portability and Accounting Act, which protects the privacy of individually identifiable health information. According to HIPAA, patients have a right to: • See and copy their health record • Update their health record • Get a list of the disclosures that a health care institution has made independent of disclosures made for the purposes of treatment, payment, and health care operations • Request a restriction on certain uses or disclosures • Choose how to receive health information What is the IRB and what do they do? - correct answer Institutional review board Approve, disapprove, or terminate all research activities that fall within its local jurisdiction according to relevant federal regulations and institutional policy. Require modifications in protocols, including protocols of previously approved research.