Certified Clinical Research Associate (CCRA) Practice Exam

What does 21 CFR 11 enable in the regulatory process for drugs and devices?

1. Use of traditional paper records

2. Compliance with international law

3. Use of electronic documents

4. Standardization of clinical trials

The correct answer is: Use of electronic documents

The regulation outlined in 21 CFR 11 primarily addresses the use of electronic records and electronic signatures in the context of clinical trials and related activities. It establishes criteria under which electronic records and signatures are considered trustworthy, reliable, and essentially equivalent to traditional paper records and handwritten signatures. This is crucial for the regulatory process for drugs and devices, as it allows for the secure and efficient management of clinical data, thereby facilitating the collection, storage, and retrieval of information in a digital format that meets regulatory requirements. The implementation of 21 CFR 11 supports organizations in transitioning to more modern systems that enhance productivity and decrease the reliance on physical documentation. This not only streamlines processes but also supports better data integrity and compliance during the drug and device approval process, ultimately leading to faster and more efficient pathways for bringing innovations to market. While compliance with international law, the use of traditional paper records, and the standardization of clinical trials hold significance in the broader context of clinical research, they do not specifically capture the fundamental essence of what 21 CFR 11 enables within the regulatory framework. The regulation's explicit focus on electronic documentation and signatures marks its critical role in facilitating modern practices in the clinical research environment.