Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

The correct answer is based on the regulatory requirement that a new Form FDA 1572, which is the Statement of the Investigator, must be signed by an investigator when a new investigator is added to the study. This form is essential as it documents the qualifications and commitments of the investigator, ensuring they understand their responsibilities for the conduct of the clinical trial.

When a new investigator joins, it is crucial to have their information officially recorded and to confirm their agreement to comply with the protocol and regulatory requirements. This maintains the integrity of the study and ensures that the roles and responsibilities are clearly defined for all investigators involved.

In contrast, while the closure of a trial site, a change in the sponsor, or changes to the duration of the trial might impact the study’s operational aspects, they do not necessitate a new Form FDA 1572 to be signed unless there is a new investigator included in the study. Thus, signing a new form is specifically tied to the addition of new investigators.