Good Clinical Practice (ICH) Questions and Answers | Latest Version | 2024/2025 | Rated A+

Good Clinical Practice (ICH) Questions and Answers | Latest Version | 2024/2025 | Rated A+ Which of the following is NOT a fundamental principle of Good Clinical Practice (GCP)? • Benefits must outweigh risks GCP emphasizes the importance of: * Balancing foreseeable risks against potential benefits * Ensuring accurate recording, handling, and storage of data to facilitate reporting, interpretation, and verification * Protecting participants' confidentiality * Conducting studies according to a well-defined protocol * Utilizing adequate information on the investigational product to support the study ICH-GCP guidelines are not a legal requirement, but rather a set of standards to ensure the integrity of clinical trials. Why are GCP guidelines important in low- and middle-income countries? • To ensure the highest standards of clinical research and participant protection What is NOT true about the informed consent process? • A participant can withdraw from the study at any time without providing a reason • The participant can sign the consent form before joining the study • Details of alternative treatments/options must be given to participants after they have given consent Informed consent requires: * Obtaining IEC/IRB approval for all participant-related materials and documents * Ensuring participants give consent freely without coercion or undue influence * Allowing participants to withdraw from the study at any time without providing a reason Can a participant's consent form be marked/signed at any time during participation if they cannot read or write? • Yes, as long as the participant has agreed