Pivot/Remote: a distributed database for remote data entry in multi-center clinical trials.

摘要: 1. INTRODUCTION. Data collection is a critical component of multi-center clinical trials. Clinical trials conducted in intensive care units (ICU) are even more difficult because the acute nature illnesses ICU settings requires that masses data be collected short time. More than thousand points routinely for each study patient. The majority still "paper-based," if remote entry (RDE) system utilized. typical RDE consists computer housed CC office and connected by modem to centralized coordinating center (DCC). Study must first recorded on paper case report form (CRF), transcribed into system, transmitted DCC. This approach additional monitoring since both CRF database verified. paper-based cannot take full advantage automatic checking routines. Much effort (and expense) trial ensuring matches original patient data. 2. METHODS. We have developed an Pivot/Remote, eliminates need CRFs. It creates innovative, distributed database. resides partially at centers (CC) Pivot/Remote descended from technology introduced with Pivot [1]. bedside laptop computers. A graphical user interface (GUI) allows display electronic CRFs closely mimic normal forms. time same as Pull-down menus, displaying possible responses, simplify process entering Edit checks performed most items. For example, entered dates conform some temporal logic imposed study. acceptable range values. Calculations, such computing subject's age or APACHE II score, automatically made entered. serially (BP, HR, etc.) can displayed graphically trend along other related variables. An audit trail created tracks all changes data, making it reconstruct any point On-line help provides information protocol well assistance use system. Electronic security makes lock certain parts once has been monitored. Completed DCC via mail where reviewed merged Questions about subject back mail. maintaining unique files among Until monitored (verified against residing hospital record), logically was collected. Copies only read there. Any pre-monitoring CC. Once monitored, moves DCC, subsequent copies flowing 3. DISCUSSION. forms utilizing portable computers used bedside. GUI quickly enter Because gets instant feedback error conditions, saved close hand. ability trended variables context detection erroneous conditions beyond simple checks. logical construction minimizes problem managing dual databases (at DCC) keeps personnel loop until made.