The rapid uptake and incorporation of computerised systems and electronic data management into clinical research needs to be backed up by sound validation processes to ensure data quality and integrity are not compromised, says the Drug Information Association (DIA).
The clinical research community “often underestimates” the impact “the use of electronic applications, computerised systems and the transmission of subject data may have on the quality and integrity of data and subject safety”, the DIA warned.
The Association was launching a new publication that applies and extends the standards formulated through the DIA’s Red Apple II GLP (Good Laboratory Practice) initiative, which addressed the design and testing of computerised systems in non-clinical research.
According to the Association, Computerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts “provides a benchmark” for applying these technologies in the clinical research setting.
Many struggle
The new publication is designed to support “the many users struggling to implement validation processes into clinical research”, thereby stimulating innovation in the clinical research environment, the DIA explained.
Proper validation and use of computerised systems will help to ensure the safety of research subjects and the credibility of clinical research data, it added.
The publication is the result of “exhaustive work” by a large group of participants from the global clinical research arena, noted Earl Hulihan, Senior Vice President, Regulatory Affairs at Medidata Solutions Worldwide.
“We carefully evaluated and compared the current use of science and technology to define best practices in the design, validation, application and use of computerised systems in the clinical research environment,” Hulihan said.
