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Telecommunication techniques in a distributed data entry system for multicenter clinical trials
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Abstracts P23 TELECOMMUNICATION TECHNIQUES IN A DISTRIBUTED DATA ENTRY SYSTEM FOR MULTICENTER CLINICAL TRIALS Larry Kamons, William Amoroso, Tim Kuntz, Nancy Remaley, and Robert Sillett
University of Pittsburgh Pittsburgh, Pennsylvania Performing file maintenance, remotely executing programs and transmitting data between microcomputers remotely located at Clinical Centers (CC) and a Data Coordinating Center (DCC) is a burdensome and tedious problem. The Epidemiology Data Center (EDC) has developed a hardware/software solution to this problem. The solution is a configuration of MS-DOS based microcomputers, 2,400 bps MNP modems, Dynatech TumOn power centers, HyperAccess communications software and HyperAccess script files written at the EDC. Customized script files allow a centralized computer located at the EDC to poll all of the CC computers at scheduled times and execute any command file. Each command file may include DOS batch commands or "Kermit-like" commands. Each communication session may be selfactualized in an unattended manner with no human intervention required. All transactions and commands performed during each session are fully audited. Automatic error recovery and retry features are implemented. In this presentation we will discuss two case studies. The system as implemented for the NHLBI Bypass Angioplasty Revascularization Investigation (BARI) and the NIDDK Liver Transplantation Database (LTD).
P24 THE IMPLEMENTATION OF A VOICE INFORMATION SYSTEM IN CLINICAL TRIALS Bruce Chow, Mlchsel Jeung, Kenneth E. James and Bor-Ming Ou DVA Medical Center Palo Alto, California When conducting clinical tdals in the Veterans Affairs environment, it is necessary for the various sites to obtain important information frequently and accurately from the Coordinating Center. The present system for this type of information transfer relies heavily on the U.S. Postal Service and on personal telephone contact which has many drawbacks. A remedy to this situation is the Voice Information System (VIS). The VIS is an unattended data transfer system which is designed to transfer data via telephone and computer. At the Palo Alto Cooperative Studies Program Coordinating Center (CSPCC), this system was modified to allow site personnel to call the Center any time of the day, and control the transfer of selected information on any subject from the computer with a regular touch-tone phone. Randomization classification, retesting options and data correction procedure were implemented in the VIS logic routines. Security and error checks of data were also incorporated into the VIS with simple programming. The voice and the touchtone input of the incoming calls are both recorded in the VIS for later referral. We will describe the implementation and use of the Voice Information System at the Palo Alto CSPCC. Flow diagrams and descriptions of clinical trial applications will be presented.
P25 THE DEVELOPMENT OF A PC-BASED DISTRIBUTED DATA ENTRY SYSTEM FOR THE P=C=HIV STUDY Joseph A. McPherson, Kenneth Abraham, Victoria Konlg, Kirk Easley, end James M. Boyett The Cleveland Clinic Foundation Cleveland, Ohio The Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted Human Immunodeficiency Virus Infection (P~C2HIV) Study is a multicentered natural history study which has developed a distdbuted data entry system on personal computers based on the FoxPro database management system (DBMS). The proper design of programs and data structures, along with the selection of commercially available software packages that integrate well with each other, allows the development of software that is both flexible and general in its applicability. Specifically, the issue of designing programs and integrating commercially available software packages in a manner that allows the resultant work to be directly generalized to other studies while still maintaining an adequate level of flexibility in the system development/maintenance cycle will be presented. The P2C2HIV study has designed a vadety of utilities that are not study specific including electronic mail, database maintenance, data communications, and file transfers. The selection of a proper DBMS software, such as FoxPro,
Abstracts P23 TELECOMMUNICATION TECHNIQUES IN A DISTRIBUTED DATA ENTRY SYSTEM FOR MULTICENTER CLINICAL TRIALS Larry Kamons, William Amoroso, Tim Kuntz, Nancy Remaley, and Robert Sillett
University of Pittsburgh Pittsburgh, Pennsylvania Performing file maintenance, remotely executing programs and transmitting data between microcomputers remotely located at Clinical Centers (CC) and a Data Coordinating Center (DCC) is a burdensome and tedious problem. The Epidemiology Data Center (EDC) has developed a hardware/software solution to this problem. The solution is a configuration of MS-DOS based microcomputers, 2,400 bps MNP modems, Dynatech TumOn power centers, HyperAccess communications software and HyperAccess script files written at the EDC. Customized script files allow a centralized computer located at the EDC to poll all of the CC computers at scheduled times and execute any command file. Each command file may include DOS batch commands or "Kermit-like" commands. Each communication session may be selfactualized in an unattended manner with no human intervention required. All transactions and commands performed during each session are fully audited. Automatic error recovery and retry features are implemented. In this presentation we will discuss two case studies. The system as implemented for the NHLBI Bypass Angioplasty Revascularization Investigation (BARI) and the NIDDK Liver Transplantation Database (LTD).
P24 THE IMPLEMENTATION OF A VOICE INFORMATION SYSTEM IN CLINICAL TRIALS Bruce Chow, Mlchsel Jeung, Kenneth E. James and Bor-Ming Ou DVA Medical Center Palo Alto, California When conducting clinical tdals in the Veterans Affairs environment, it is necessary for the various sites to obtain important information frequently and accurately from the Coordinating Center. The present system for this type of information transfer relies heavily on the U.S. Postal Service and on personal telephone contact which has many drawbacks. A remedy to this situation is the Voice Information System (VIS). The VIS is an unattended data transfer system which is designed to transfer data via telephone and computer. At the Palo Alto Cooperative Studies Program Coordinating Center (CSPCC), this system was modified to allow site personnel to call the Center any time of the day, and control the transfer of selected information on any subject from the computer with a regular touch-tone phone. Randomization classification, retesting options and data correction procedure were implemented in the VIS logic routines. Security and error checks of data were also incorporated into the VIS with simple programming. The voice and the touchtone input of the incoming calls are both recorded in the VIS for later referral. We will describe the implementation and use of the Voice Information System at the Palo Alto CSPCC. Flow diagrams and descriptions of clinical trial applications will be presented.
P25 THE DEVELOPMENT OF A PC-BASED DISTRIBUTED DATA ENTRY SYSTEM FOR THE P=C=HIV STUDY Joseph A. McPherson, Kenneth Abraham, Victoria Konlg, Kirk Easley, end James M. Boyett The Cleveland Clinic Foundation Cleveland, Ohio The Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted Human Immunodeficiency Virus Infection (P~C2HIV) Study is a multicentered natural history study which has developed a distdbuted data entry system on personal computers based on the FoxPro database management system (DBMS). The proper design of programs and data structures, along with the selection of commercially available software packages that integrate well with each other, allows the development of software that is both flexible and general in its applicability. Specifically, the issue of designing programs and integrating commercially available software packages in a manner that allows the resultant work to be directly generalized to other studies while still maintaining an adequate level of flexibility in the system development/maintenance cycle will be presented. The P2C2HIV study has designed a vadety of utilities that are not study specific including electronic mail, database maintenance, data communications, and file transfers. The selection of a proper DBMS software, such as FoxPro,