For sites conducting clinical trials in the EU, what specific labeling requirement must be met?

The requirement for labeling in clinical trials conducted in the EU includes specifying the period of use for the product, which is essential for ensuring that participants are informed about how long they can safely use the investigational product. This information is crucial for maintaining participant safety and supporting compliance throughout the trial.

The period of use helps to prevent potential adverse effects associated with prolonged use beyond the indicated timeframe and informs both participants and investigators about the appropriate duration for which the product is intended to be utilized. It aids in the assessment of the product's effects and provides necessary instructions for managing the trial effectively.

While other labeling elements may also be important in various contexts, such as a manufacturer's name or an expiration date, the specific mention of the period of use is critical in the regulatory framework governing clinical trials, emphasizing the importance of participant safety and informed consent within the clinical setting.