2025 CITI GCP Practice Exam – Complete Study Resource

For participation in a clinical trial, the essential documents primarily focus on the scientific and ethical aspects of the study. The protocol outlines the trial's objectives, design, methodology, statistical considerations, and the organization of the study, making it crucial for guiding the trial's execution and ensuring compliance with Good Clinical Practice (GCP) requirements.

The informed consent form is vital for ensuring that participants are fully informed about the nature of the trial, potential risks, benefits, and their rights. Participants must understand what their involvement entails and provide written consent, which is a cornerstone of ethical clinical research.

Institutional Review Board (IRB) approval is necessary as it ensures that the trial's ethical aspects have been evaluated and that participant rights and welfare are protected throughout the study. This approval is a regulatory requirement before the trial can begin.

In contrast, marketing materials are not essential for the actual conduct of the study. They may serve promotional purposes or assist with recruitment efforts but do not impact the scientific integrity or ethical framework necessary for running a clinical trial. Thus, while they can be useful, they are not required documentation for participating in the trial.