GCP- Social and Behavioral Research Best Practices for Clinical Research 2023 updated with verified

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 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 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 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 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 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 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 and compare them on a day-to-day basis - c. Compare current IRB protocol verbiage to previously submitted and IRB-approved protocols for consistency - d. Create SOPs from scratch for each study to ensure accuracy c. Compare current IRB protocol verbiage to previously submitted and IRB-approved protocols for consistency True or False: All amendments to a clinical protocol must be submitted, and prior to implementation, approved by your IRB - a. True - b. False a. True Marika has been working with a group of participants for several months and she's gotten to know them quite well. She has especially enjoyed working with Mr. Grummell. During a recent exercise study, Markia offered him a few extra words of encouragement. What has Markia done wrong? - a. She was too nice to Mr. Grummell - b. She didn't do anything wrong. Part of her job is to make participants comfortable and encourage them during a study - c. She deviated from the clinical protocol by offering extra words of encouragement to only one participant - d. She became too attached to a participant in her study c. She deviated from the clinical protocol by offering extra words of encouragement to only one participant True or False: To make sure that enough participants are enrolled in your study, it is appropriate to persuade a participant after he has said he does not want to participate. - a. True - b. False b. False True or False: Participants are more likely to leave a study if they find involvement to be a hassle - a. True - b. False a. True Choose all that apply. Printed materials should include: - a. The basics of the study - b. Accurate information - c. Eye-catching graphics - d. A promise of a cure a. The basics of the study b. Accurate information c. Eye-catching graphics What is the simplest way to assess which of your recruiting efforts work best? - a. Most recruiting efforts have the same success rate- evaluate your own by comparing the cost and time to implement each one - b. Visit your flyer locations on a daily basis to see how many are being picked up - c. Ask potential participants how they heard about the study - d. Search "successful recruitment methods" on the internet c. Ask potential participants how they heard about the study Unfortunately, a participant has decided to leave the study. What is the first step you should take? - a. Ask the participant to help find a replacement - b. Refer to your clinical protocol to review the process for participants who are withdrawing - c. There is no action required- the study will be fine without one participant b. Refer to your clinical protocol to review the process for participants who are withdrawing Which of the following statements is true? - a. Participants cannot speak about their experience to people outside of the study - b. Participation in a research study can cure the participant's disease - c. Once a participant has consented to being involved in a study, his participation is mandatory - d. Because participation in a social and behavioral research study is voluntary, a participant may choose to withdraw at any time d. Because participation in a social and behavioral research study is voluntary, a participant may choose to withdraw at any time Which of the following are methods used to ensure participant comprehension? Choose all that apply. - a. Sending a copy of the consent form ahead of time for the participant to review - b. Using the 6th to 8th grade reading level when writing consent - c. Asking the participant to summarize or explain certain elements in their own words - d. Asking a family member to be present in order to give consent on behalf of the participant a. Sending a copy of the consent form ahead of time for the participant to review b. Using the 6th to 8th grade reading level when writing consent c. Asking the participant to summarize or explain certain elements in their own words A PI has added an additional physical test to her study. The new test involves slightly different risks to her study participants. What is her best course of action? - a. Call each participant immediately and explain the new test and any possible risk, then obtain their verbal consent to continue participation in the study - b. To ensure that all participants receive the same verbiage, she must mail a revised consent to each participant with the new information highlighted - c. She must revise the consent form, then review the new form with each participant in a face-to-face conversation - d. She must submit a revised consent, highlighting the new test and any associated risk, to her IRB, and continue using the same methods previously used c. She must revise the consent form, then review the new form with each participant in a face-to-face conversation