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

Investigational products must be stored according to protocol specifications and the manufacturer's directions because these guidelines are designed to ensure the integrity, safety, and efficacy of the investigational products. Each investigational product comes with specific storage requirements that may include temperature controls, light protection, humidity levels, and other conditions that must be strictly adhered to in order to maintain the product's stability and effectiveness throughout the study.

Storing investigational products according to protocol and manufacturer specifications helps prevent degradation or changes in the product that could compromise the study's outcomes. Additionally, proper storage aligned with these directives ensures compliance with regulatory standards and upholds participant safety during clinical trials.

While general storage rules or FDA guidelines might provide some relevant information, they do not replace the need to follow the specific protocols and directions developed for each investigational product. The investigator's discretion, while important in certain aspects of study management, should always align with these established guidelines to ensure regulatory compliance and participant safety.