Certified Clinical Research Associate (CCRA) Practice Exam

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Prepare for the CCRA Exam with interactive flashcards and multiple choice questions, each offering hints and detailed explanations. Equip yourself with the knowledge you need for certification success!

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When is it acceptable for an investigator to not use a new Form FDA 1572?

  1. When a new protocol is added to the study

  2. When there are no changes in study personnel

  3. When the IND is still active

  4. When the trial has started

The correct answer is: When there are no changes in study personnel

The correct choice highlights situations in which the use of a new Form FDA 1572 is not necessary. The Form FDA 1572 is essentially a statement of the investigator's commitments and provides essential information about the study, including details about the study site and personnel. In instances where there are no changes in study personnel, the current Form FDA 1572 remains valid, as it already includes the relevant information regarding the investigators involved in the study. This means that the responsibilities and qualifications for those conducting the trial are already documented, and therefore, there is no need to submit a new form unless there are modifications to the team. Other scenarios, such as adding a new protocol or starting the trial, typically require updates to the existing documentation to ensure that everything is current and reflective of the study's requirements. If the investigational new drug (IND) is still active, this does not directly relate to the necessity of the form; rather, it pertains to the ongoing nature of the study and oversight compliance.