What is the best action for a regulatory professional who discovers operational difficulties during the review of a clinical trial protocol?

Consulting with the regulatory agency is a crucial step when a regulatory professional identifies operational difficulties during the review of a clinical trial protocol. Engaging with the regulatory authority allows for clarification on the regulatory expectations, guidance on how to address the specific difficulties encountered, and potentially obtaining a pathway to resolve challenges that could affect the trial's compliance and approval. This direct line of communication can lead to more informed decisions that align with regulatory requirements ensuring that the study can be conducted smoothly while adhering to governance standards.

While consulting with the clinical trial team is important and conducting a feasibility study can provide insights into operational viability, these actions may not provide the necessary regulatory perspective that is critical for ensuring compliance. Revising the protocol independently could lead to deeper issues, as modifications made without regulatory input might not meet the necessary guidelines or could further complicate the trial's approval status. Therefore, seeking a consultation with the regulatory agency stands out as the most comprehensive and strategic approach.