Certified Clinical Research Coordinator (CCRC) Practice Exam

What is Form FDA 1572 primarily associated with in clinical research?

1. Informed consent documentation

2. Study randomization procedures

3. Investigator's agreement to personally conduct or supervise the investigation

4. Patient recruitment strategies

The correct answer is: Investigator's agreement to personally conduct or supervise the investigation

Form FDA 1572, also known as the Statement of Investigator, is fundamentally tied to the investigator's commitment to personally conduct or oversee the clinical investigation. This form signifies the investigator’s agreement to fulfill the responsibilities associated with the trial, ensuring compliance with regulatory requirements. It outlines the investigator's qualifications, the study protocol, and the responsibilities that they must uphold throughout the study. The importance of this form cannot be overstated, as it establishes the investigator's accountability for the study's conduct and the protection of study participants. By signing this form, the investigator affirms their understanding of the protocol, the device or drug being studied, and their role in ensuring that the investigation is carried out in accordance with Good Clinical Practice (GCP) and related regulations. This framework is critical for maintaining the integrity of clinical research and ensuring participant safety. In the context of clinical trials, the other aspects mentioned—such as informed consent documentation, study randomization, and patient recruitment strategies—are certainly important elements of the overall research process. However, they are not directly encapsulated by Form FDA 1572, making it clear that the focus of the form is specifically on the investigator's agreement to conduct the research.