GCP- Social And Behavioral Research Best
Practices For Clinical Research
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 ANS✔✔ 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 ANS✔✔ 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 ANS✔✔ 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 ANS✔✔ 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:
, Solution 2024/2025
Pepper
- a. Protecting participants
- b. Ensuring quality data
- c. Hiring study staff ANS✔✔ 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 ANS✔✔ 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 ANS✔✔ 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 ANS✔✔ 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
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