ABSTRACT
From the time that data management groups were first formed, they set up studies, collected or entered data, cleaned those data, and processed them until the study could be considered ready for analysis. For the most part, they all did a good job of this and produced datasets with accurate data that reflected values provided by the investigator sites. Over time, as the idea of “if you didn’t document it, it wasn’t done” became the rule, groups made an effort to produce documents at key points along the way to record what was done and to provide evidence of good practice. These documents were (and still are) filed together in what is frequently referred to simply as the “study file.” To ensure that study files across groups were consistent, these companies eventually wrote standard operating procedures (SOPs) that outlined what the contents of each study file should be.
