PIVOT QUIZ - GOOD CLINICAL PRACTICE correctly answered graded A+ 2023/2024

PIVOT QUIZ - GOOD CLINICAL PRACTICE NOT a principle of GCP: - correct answer Publication of results is not required if the study results were not as expected. ICH-GCP guidelines are a legal requirement and studies found not following it will be terminated. - correct answer False It is important for investigators in low-and middle-income countries to adopt good clinical practice guidelines because their studies will consequently be recognised as being of the same standard as other GCP compliant studies across the globe. - correct answer True Which of the following is NOT true about the informed consent process: (Please select all that apply) - correct answer 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. 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 into another study. - correct answer False Participants in a study with an investigational medicinal product should only contact the study physician if feeling unwell if their own physician is unavailable. - correct answer False