GCP- Social and Behavioral Research Best Practices for Clinical Research rated A+

You overhear someone say the following about Good Clinical Practice (GCP) in the hallway: "GCP is mostly just meant to curb abuses by unscrupulous researchers who make bad decisions in response to pressure to discover the next big thing." What could you say in response to this? - a. That's right; GCP are very rigorous rules that every researcher must follow - b. That's not quite right, because GCP is really more about the behavior of participants...NOT about the behavior of researchers - c. It's true that GCP was developed in part to concerns about unethical behavior, but overall it aims to ensure that clinical trials are carried out in a way that protects participants and ensures high quality study data - Answer- c. It's true that GCP was developed in part to concerns about unethical behavior, but overall it aims to ensure that clinical trials are carried out in a way that protects participants and ensures high quality study data True or False: Following Good Clinical Practice (GCP) is one way to help minimize your risk of non-compliance - a. True - b. False – Answer- a. True True or False: Good Clinical Practice (GCP) is an approach used by researchers to only care for participants who are involved in a drug, device, or biologic trial - a. True - b. False - Answer- b. False True or False: Maintaining a detailed study log that identifies the interviewers making phone calls, tracks the number of phone calls they made, and when, and includes written notes for the next shift of interviewers is an example of GCP - a. True - b. False - Answer- a. True Choose all that apply. The International Conference on Harmonization (ICH), held in 1990, laid out a foundation of guidance for all clinical research, including minimum standards for: - a. Protecting participants - b. Ensuring quality data - c. Hiring study staff - Answer- a. Protecting participants b. Ensuring quality data 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 - Answer- 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