ICH Good Clinical Practice question n answers graded A+ 2023/2024

ICH Good Clinical PracticeWhat is GCP? - correct answer You're probably wonder what Good Clinical Practice, or GCP, is exactly! In 1990, a conference called the International Conference on Harmonization took place and GCP guidelines were created. According to this document, GCP is: "A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected." Rights of Safety of Human Subjects - correct answer The rights and safety of human subjects should always be first priority. By being in a study, a person is putting themselves at risks they would otherwise not be exposed to had they not signed up for the study. As such, it is the job of the CRC to make sure their rights and safety are always at the forefront of all decisions and procedures carried out during the trial. Risk to Benefit ratio - correct answer Risk to benefit ratio - any foreseeable risks should be weighed against the potential benefits of the trial. The sponsor, CRO, and PI should all evaluate this before submitting a trial to the IRB. The IRB will also weight the risk:benefit ratio. If the benefits justify the risks, the IRB may approve the trial. Investigator Brochure - correct answer Investigator Brochure (IB) is a document that contains all of the information known to date about the investigational product, including but not limited to chemical makeup, pharmacokinetics, results of animals studies, dosing information, and any known safety information. The IB is used to understand the rationale and justification for the study. Protocol - correct answer The protocol is your guide for everything trial-related. It gives the background, rationale, and specifics of everything that must be carried out during the trial. The protocol must be approved by the IRB before a study can start. Qualifications and Training - correct answer All staff working on the trial must be qualified to do their job and have proper training. Qualifications should be apparent on one's CV and training should be tracked in the training log.