GCP- Social and Behavioral Research Best Practices for Clinical Research Questions and Answers | Latest Update | 2024/2025 | Already Passed

GCP- Social and Behavioral Research Best Practices for Clinical Research Questions and Answers | Latest Update | 2024/2025 | Already Passed What could you say in response to someone who says Good Clinical Practice (GCP) is mostly about curbing abuses by unscrupulous researchers? a. That's correct, GCP is all about strict rules b. That's not true, GCP is more focused on participant behavior c. It's true that GCP was developed to address concerns about unethical behavior, but it's also important for ensuring high-quality data and participant protection What is one way to minimize your risk of non-compliance in a clinical trial? a. Failing to follow GCP guidelines b. Following GCP guidelines True or False: Good Clinical Practice (GCP) is only necessary for studies involving drugs. a. True b. False What is an example of a practice that aligns with Good Clinical Practice (GCP)? a. Keeping a detailed study log b. Not keeping a study log c. Only keeping a study log during working hours d. Only keeping a study log for important calls e. Not using a study log at all What was the International Conference on Harmonization (ICH) founded for? a. To ensure that all clinical research is carried out in a consistent manner across different countries b. To develop new treatments for diseases c. To protect participants in clinical trials A PI is struggling to set a timeframe for follow-up study visits. She thinks a check-in one month after an initial visit is appropriate, but her coordinator recommends that the follow-up occur at two months. What should be written in the IRB protocol to accommodate both opinions? - a. One month- the IRB will require exact specifications - b. One month plus or minus one week- a range like this will minimize later deviations, but include enough specificity within the IRB protocol - c. 3 months- it is beneficial to "pad" the estimate, so it will never run over the time listed in the IRB protocol b. One month plus or minus one week- a range like this will minimize later deviations, but include enough specificity within the IRB protocol True or False: Your study team can begin participant related activities, such as recruitment before a protocol is approved by the IRB - a. True - b. False b. False Which of the following is a best practice for ensuring treatment fidelity in a behavioral intervention? - a. Encourage participants to return for multiple studies by offering rewards - b. Record participant interactions