Use of computerized systems in clinical research: A regulatory perspective

Abstract

Electronic source data and documentation from clinical investigations should be attributable, legible, contemporaneous, original and accurate. 21 Code of Federal Regulations (CFR) Part 11 provides acceptance criteria for electronic records, signatures, and handwritten signatures executed to electronic records. All study protocols should identify each step at which a computerized system will be used to create, modify, maintain, archive, retrieve, or transmit source data. Standard operating procedures and controls should be established when using computerized systems to create, modify, maintain, or transmit electronic records, and when collecting source data at clinical trial sites. Access must be limited to authorized individuals. Computer generated, time-stamped electronic audits trails should be undertaken to track changes to electronic source documentation. Controls should be established to ensure that the system’s date and time are correct. Procedures and controls should be put in place to prevent the altering, browsing, querying, or reporting of data via external software applications that do not enter through the protective system software. Prompts, flags, or other help features should be incorporated in a computerized system to encourage consistent use of clinical terminology. Individuals should have training necessary to perform their assigned tasks.