Clinical Data Acquisition, Storage and Management

Definition The management of clinical data for supporting patient care and for supporting retrospective clinical research requires a means to acquire the clinical data and a repository that stores the data and provides the functions necessary for managing them over their lifetime. Typically, patient data are collected ‘‘at the point of care’’ (i.e. onsite where health care is being provided) and entered into a patient record system [1]. Data entry is typically the first line of precaution for maintaining a certain amount of quality on the data collected. Subsequently, a representative from an externally sponsoring organization or authorized personnel from within the health care institution then extracts a select set of medical record data into a Clinical Data Management System (CDMS). The entries in such systems are often referred to as secondary patient records since they are derived from a primary patient record and are used by personnel who are not involved in direct patient care [1]. These systems are also often referred to as patient registries. The study committee of the Institute of Medicine (IOM) defined [1] a computer-based patient record (CPR) as