What is a Letters of Cross-Reference used for in clinical trials?

The use of Letters of Cross-Reference in clinical trials is primarily to enable reference to previously submitted Investigational New Drug (IND) information. This tool facilitates the efficient sharing of relevant data that has already been evaluated by regulatory authorities, streamlining the process of reviewing new submissions. It allows investigators and sponsors to cite relevant information from prior IND applications or submissions, ensuring that key findings and regulatory feedback are easily accessible without the need to resubmit all the prior data.

In contrast, outlining individual subject data pertains to the documentation of specific findings related to the participants in the study, which does not fall under the purview of Cross-Reference letters. Compiling consent forms from different studies involves managing informed consent documentation, which is a separate process focused on participant rights and understanding. Recording adverse events is essential for safety monitoring during a clinical trial but is not the purpose of a Letter of Cross-Reference. Thus, the correct answer highlights the importance of efficiently utilizing previously submitted regulatory information within the framework of clinical trials.