ICH Good Clinical Practice question n answers 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. Subjects' Medical Care - correct answer A qualified physician or trained professional should be charged with making all medical decisions during the course of a trial. For example, if the study involved foot health, then a podiatrist may be added as a sub-investigator. Likewise, if a mouth exam is needed, then a dentist may be necessary to add to the study staff. Individuals with appropriate training should be delegated to perform the tasks specific to their training, aways keeping in mind the well-being of the subjects. Informed Consent - correct answer Informed consent should be obtained from all research subjects prior to any study-related procedures occurring. The informed consent form (ICF) tells the subject everything that they need to know about the study. Good Manufacturing Practices - correct answer Good manufacturing practice refers to the shipping and storage of investigational product throughout the study. All guidelines and regulations must be followed when it comes to shipping and storing a product that will be given to human subjects. Documentation - correct answer All documentation throughout the study should be attributable, legible, contemporaneous, original, and accurate. This helps to protect the safety of subjects and ensures that the data is collected and recorded correctly. Confidentiality - correct answer The confidentiality of all records must be protected throughout a clinical trial. All necessary steps must be taken to ensure that a subject's records are kept private and confidential at all times. If a breach occurs, proper regulatory bodies must be informed. Quality Assurance - correct answer Every site running a clinical trial should have standard operating procedures in place to ensure quality assurance. The study monitor (aka CRA) will also help with quality assurance. Investigator Responsibilities - correct answer The investigator: -Has ultimate responsibility for the entire conduct of the trial -Ensures that all staff are adequately trained to carry out tasks -Delegates tasks to study staff