A Systems Audit Approach to Nonstandard Systems in Clinical Research

“Standard” models of pharmaceutical clinical research typically involve the prospective execution of an approved study protocol by a clinical investigator and the transcription of study data from source documents (medical records) to a case report form by the investigator or a research coordinator, with audit and review performed by a study monitor. Other models of clinical research, or methods of clinical data collection, may be thought of as “nonstandard.” One example of a nonstandard clinical research model involves the retrospective collection of clinical data, that is, data which were either not originally generated as part of a research protocol, or were generated as part of one or more protocols with different original purposes and intents. Data from such studies may be collected by personnel with no direct involvement in the original study. Another “nonstandard” system involves studies which are primarily dependent on results from specialized laboratory analyses for their primary efficacy or safety endpoints. Through the use of a process- or systems-oriented quality assurance program, the critical components of these diverse nonstandard systems can be identified and evaluated, using the same set of basic principles, so that overall data quality can be assessed.