What is a critical requirement for a new database system chosen by a medical center for clinical research?

Choosing a database system for clinical research in a medical center mandates that the system be "Part 11 compliant." This compliance refers to the regulations set forth by the FDA, which require electronic records and electronic signatures to be trustworthy, reliable, and equivalent to traditional paper records. This is vital in a clinical research context, where maintaining data integrity and security is paramount for regulatory approval and for ensuring the validity of the research outcomes.

Part 11 compliance ensures that the database incorporates necessary features such as audit trails, validation, access controls, and the ability to ensure data privacy and integrity. These features are especially crucial when handling sensitive patient information and maintaining compliance with regulations that govern clinical trials.

While cost-effectiveness, user-friendliness, and a focus on patient records are important considerations, they do not address the regulatory aspects of data handling and integrity required for clinical research. Ensuring compliance with Part 11 is fundamental to safeguarding the rigor and compliance of clinical research activities.