SOCRA CCRP Practice Exam

In what ways can an IND safety report be submitted for drug studies?

1. Narrative document

2. FDA Form 3500A

3. Electronic format that FDA can process, review, archive

4. All of the above

The correct answer is: All of the above

An Individual New Drug (IND) safety report can be submitted through various methods such as a narrative document, FDA Form 3500A, or an electronic format that can be processed, reviewed, and archived by the FDA. These options are not exclusive and all are acceptable for submission. Selecting only one of the options listed would not be a comprehensive or accurate answer. Therefore, the correct answer is option D, as all listed methods can be used to submit an IND safety report for drug studies.