Good Clinical practice (ICH), Exam Questions and answers, rated A+/LATEST UPDATES, 2024/25/ EXAMS PREDICTION PAPER/

Good Clinical practice (ICH), Exam Questions and answers, rated A+ Which of the following is NOT a principle of GCP: (Please select all that apply) Any foreseeable risks and inconveniences must be weighed up against any benefits Information must be recorded, handled and stored in a manner that allows accurate reporting, interpretation and verification and which ensures the confidentiality of participants' records. Publication of results is not required if the study results were not as expected. The study protocol must provide inclusion and exclusion criteria, monitoring details and a publication policy. Available non-clinical and clinical information on the investigational medicinal product being used must be adequate to support the study. The study must be conducted according to the Nuremberg Code of 1947 - -Publication of results is not required if the study results were not as expected. The study must be conducted according to the Nuremberg Code of 1947 ICH-GCP guidelines are a legal requirement and studies found not following it will be terminated. True False - -False It is important for investigators in low-and middle-income countries to adopt good clinical practice guidelines because their studies will conseque... True False - -True Which of the following is NOT true about the informed consent process: (Please select all that apply) IEC/IRB approval must be gained for all participant related materials and documents. Details of any alternative treatments/options must be given to participants after they have given consent Consent must be given freely without coercion or undue influence. A participant can withdraw from the study at any time without providing a reason. If the participant cannot read or write the consent form can be marked/signed at any time during participation as long as the participant has agreed to join the study. - -If the participant cannot read or write the consent form can be marked/signed at any time during participation as long as the participant has agreed to join the study. Details of any alternative treatments/options must be given to participants after they have given consent As long as you document the entire process, you can unblind a participant at the request of a site investigator who wants to enter the participant ... True False - -False Participants in a study with an investigational medicinal product should only contact the study physician if feeling unwell if their own physician ... True False - -False Approval from the IEC/IRB is not required for which of the following: Study management plan Study protocol Compensation plans - -Study management plan The IMP temperature was not recorded for 3 days, according to protocol this should have been monitored daily; who will you hold responsible