Development and deployment of an internet-based data management system for use by the Asthma Clinical Research Network.

Data management system development for the first Asthma Clinical Research Network (ACRN) study began at the data coordinating center (DCC) in May 1995 with the requirement for delivery of a production system by November 1995. Special methods had to be used to establish an internet local area network (LAN), place clinical client systems, and achieve an accelerated software development cycle. The development of a fully integrated data management system prior to the start of the study was not possible. Therefore an early analysis focused on identifying discrete groupings of data management functions that would allow development of distinct database modules to provide specific functionality such as subject randomization, subject registration, and data entry. The modules were categorized as either being associated with clinical centers or the DCC so that the clinical center modules could be developed and delivered to meet the start date of the study. In the second phase of development during the relatively slow patient-enrollment period, the DCC functional modules were delivered discretely over time. While at the time this development model was a necessity due to limited DCC resources, it continues to be used today as it permits the DCC to implement studies more rapidly and efficiently for the ACRN. This paper describes the methodologies used to develop an internet-based LAN, establish clinical center client systems, establish DCC client and server operations, and develop a data management system. It describes the circumstances that contributed to the development of these systems and the special methodologies developed. The technical aspects of the data management system and LAN are presented as well as a description of the requirements and constraints analysis used to develop the hardware and software systems.

Data management procedures in the Asthma Clinical Research Network.

Well-designed data management processes are essential in ensuring the quality of data collected in multicenter clinical trials. This paper describes the data management processes and systems that were developed by the data coordinating center of the Asthma Clinical Research Network. A combination of manual and electronic processes has been designed to process clinical trial data from the point of collection to statistical analysis. A distributed database management system consisting of modular applications for separate data processing activities was developed to enter, track, verify, validate, and edit collected data. In addition, processes for monitoring and reporting data quality are discussed.

Effects of alcohol intoxication on risk taking, strategy, and error rate in visuomotor performance.

Adult men (N = 44) participated for 2 days (alcohol vs. placebo treatment) in a double-blind, crossover experiment. Performance on the Digit Symbol Substitution Task (DSST) and a visuomotor (VM) task was measured 4 times each day. On the alcohol-treatment day, data were obtained once during ascending breath alcohol levels (BALs), once during maximal BALs (0.05 or 0.10), and twice during descending BALs. Data were collected at the same time points on the placebo-treatment day. Limited evidence for acute tolerance was obtained with the DSST, but error rates on the VM task were higher during maximal and descending BALs. Error rates remained near placebo values, and participants displayed slightly greater caution, while BALs were ascending. Strategy scores on the VM task exceeded placebo scores during maximal intoxication. Data interpretation is focused on individuals in higher level (e.g., professional) positions.