A company discovers that one site has not consented a significant portion of its study subjects properly. What is the first action the company should take?

In this scenario, the first course of action the company should take is to re-consent all improperly consented subjects. Ensuring that all study participants have provided proper informed consent is a fundamental regulatory requirement and an ethical obligation in research involving human subjects. Proper consent is essential not only to uphold the integrity of the study but also to protect the rights and welfare of the participants.

Re-consenting the improperly consented subjects helps to rectify the breach in compliance and reinforces the ethical standards of the research. It ensures that these subjects are fully informed about the study, the potential risks, and their rights, thereby maintaining their autonomy and trust.

In contrast, other options like stopping the entire study or informing the FDA and asking for guidance may be required later but do not address the immediate need to correct the consent issues. Re-training study staff, while important for preventing future issues, is also a secondary step that does not resolve the current problem of improperly consented subjects.