SOCRA CCRP Practice Exam

In what ways does a sponsor ensure investigators obtain informed consent from participants?

1. Annual compliance training for investigators

2. Obtaining a signed FDA 1572 form

3. Dispatching bi-weekly newsletters

4. Conducting public seminars

The correct answer is: Obtaining a signed FDA 1572 form

A. Annual compliance training for investigators is not the best way for sponsors to ensure that investigators obtain informed consent from participants. While training can help investigators understand the rules and regulations, they still need to obtain informed consent directly from participants. B. Obtaining a signed FDA 1572 form is the correct way for a sponsor to ensure investigators obtain informed consent from participants. This form is used to document the investigator's agreement to comply with certain regulations and obtain informed consent from participants. C. Dispatching bi-weekly newsletters is not an effective method for ensuring that investigators obtain informed consent from participants. While newsletters may provide information about regulatory updates, they do not directly ensure that informed consent is obtained. D. Conducting public seminars may help raise awareness about the importance of informed consent and provide education for investigators. However, it is not the most effective method for ensuring that investigators actually obtain informed consent from participants