Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

The correct choice indicates that 'lot expiration' is not part of the minimum primary information required on investigational drug labels. In clinical research, investigational drug labels are primarily focused on providing essential information needed for the safe handling and administration of the drug within the study context.

The required elements typically include the name of the study, which helps identify the clinical trial and its purpose. Instructions for use are essential to guide healthcare professionals on how to properly administer the investigational drug. The lot number is crucial for tracking the specific batch of the drug for quality control and monitoring any potential adverse reactions.

While lot expiration dates are important for commercial pharmaceuticals, in the context of investigational drugs, the focus is more on safety and identification rather than expiration. It's essential that investigational drugs are used within their effective timeframe; however, this information may be documented elsewhere and is not typically mandated to be on the investigational label itself. Thus, 'lot expiration' does not meet the minimum primary requirements established for investigational drug labeling.