Regulatory Affairs Certification (RAC) Practice Exam

What information related to a clinical investigator who conducts Phase I pharmacokinetic studies must be disclosed with your IND submission if they receive a retainer for another product?

1. Additional forms are required

2. No additional forms are required

3. Only financial disclosures are needed

4. The investigator's credentials must be submitted

The correct answer is: No additional forms are required

In the context of an Investigational New Drug (IND) submission for Phase I pharmacokinetic studies, the requirement for disclosure focuses on the financial interests of clinical investigators involved in the study. If a clinical investigator receives a retainer for another product, the regulation mandates that this financial interest should be disclosed as it may create a potential conflict of interest or bias in conducting the study. However, simply noting that no additional forms are required implies that the existing regulatory framework and forms already suffice to capture necessary financial disclosures without necessitating extra documentation for this specific scenario. This is aligned with the regulatory guidance that emphasizes the need for transparency but also balances the requirement for unnecessary duplication of effort in the submission process. Thus, indicating that no additional forms are required streamlines the disclosure process while ensuring that the pertinent financial conflicts are addressed appropriately.