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Electronic reconciliation reporting
Abstracts
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and facilitate the optimal use of WW facilities and personnel. This approach eliminates redundant research efforts, capitalizes on the WW economy of scale, minimizes the number of protocols carried out, and establishes a single WW database from which all data can be immediately accessed for efficient and consistent reporting WW.
Electronic Reconciliation Reporting J u d y Worth, Diane Seif, a n d D e n i s e H a r p e r
Marion Laboratories, Inc., Kansas City, Missouri (P02) A trial management system to electronically calculate and reconcile study drug inventory records was used in a large, long-term multicenter trial. The system generated reports for clinical supply, regulatory compliance, clinical research, and investigator study sites. Data presentation details the following reports: Final Comparison Report Discrepancy Report Case Report Form Detail Drug Log Detail Unassigned Patient Numbers Summary Report By Lot Number Clinical Supply Patient Detail Report Patient Reconciliation Status Report Used to document GCP compliance, detailed reports aided investigation and resolution of discrepancies. In addition, the system allowed a means to identify final reconciliation status of each patient in the study.
Education and Orientation of a Contract Research Group to Co-Monitor and Close Out a Multicenter Study Larry Dollar, Diane Seif, Sue Ruckh, Esam Sidarous, a n d J u d y W o r t h
Marion Laboratories, Inc., Kansas City, Missouri (P03) A need was identified for help in monitoring a 38-site multicenter trial as well as conduct study closure visits for the same trial. The use of a contract research group was deemed necessary to complete this task. This large multicenter trial had a patient enrollment of 2500, with an individual site enrollment range of 18 to 179. The primary research needs required by the sponsor of the contract group were as follows: (1) monitoring and maintenance of protocol compliance; (2) drug accountability and data integrity; (3) prompt and accurate reporting of events; (4) confidentiality; and (5) ethical practices in clinical research. The training and orientation process was effectively accomplished and the needs of the sponsor were deafly defined using a two-step approach: (1) day-long workshops and (2) co-monitoring. This presentation addresses the development of these study management processes.
Microcomputer-Based Data Management and Statistical Analysis in a VA Cooperative Study D o m e n i c J. Reda, Yui-Li H s u , D o r o t h y H o n g , a n d the VA Cooperative TURP Group Hines VA Cooperative Studies Program Coordinating Center, Hines, Illinois (P04) Advances in hardware design and the conversion of mainframe database management and statistical analysis software packages to the microcomputer environment have made it possible to perform all data processing for large clinical trials on a microcomputer. VA Cooperative Study #246 is designed to compare TURP surgery to medical follow-up in men over age 55 with moderately symptomatic benign prostatic hyperplasia. The study is being conducted at nine VA urology departments with a target sample size of 526 patients. The medical database will grow to 25,000 records. A medical resource utilization database is also being maintained for a costeffectiveness subprotocol and will contain over 50,000 records. All data processing, including data entry, database management and interim statistical analyses are being conducted on an IBM PC AT. This presentation focuses on the selection of hardware and software, systems design, and problems encountered that are unique to the microcomputer environment.
263
and facilitate the optimal use of WW facilities and personnel. This approach eliminates redundant research efforts, capitalizes on the WW economy of scale, minimizes the number of protocols carried out, and establishes a single WW database from which all data can be immediately accessed for efficient and consistent reporting WW.
Electronic Reconciliation Reporting J u d y Worth, Diane Seif, a n d D e n i s e H a r p e r
Marion Laboratories, Inc., Kansas City, Missouri (P02) A trial management system to electronically calculate and reconcile study drug inventory records was used in a large, long-term multicenter trial. The system generated reports for clinical supply, regulatory compliance, clinical research, and investigator study sites. Data presentation details the following reports: Final Comparison Report Discrepancy Report Case Report Form Detail Drug Log Detail Unassigned Patient Numbers Summary Report By Lot Number Clinical Supply Patient Detail Report Patient Reconciliation Status Report Used to document GCP compliance, detailed reports aided investigation and resolution of discrepancies. In addition, the system allowed a means to identify final reconciliation status of each patient in the study.
Education and Orientation of a Contract Research Group to Co-Monitor and Close Out a Multicenter Study Larry Dollar, Diane Seif, Sue Ruckh, Esam Sidarous, a n d J u d y W o r t h
Marion Laboratories, Inc., Kansas City, Missouri (P03) A need was identified for help in monitoring a 38-site multicenter trial as well as conduct study closure visits for the same trial. The use of a contract research group was deemed necessary to complete this task. This large multicenter trial had a patient enrollment of 2500, with an individual site enrollment range of 18 to 179. The primary research needs required by the sponsor of the contract group were as follows: (1) monitoring and maintenance of protocol compliance; (2) drug accountability and data integrity; (3) prompt and accurate reporting of events; (4) confidentiality; and (5) ethical practices in clinical research. The training and orientation process was effectively accomplished and the needs of the sponsor were deafly defined using a two-step approach: (1) day-long workshops and (2) co-monitoring. This presentation addresses the development of these study management processes.
Microcomputer-Based Data Management and Statistical Analysis in a VA Cooperative Study D o m e n i c J. Reda, Yui-Li H s u , D o r o t h y H o n g , a n d the VA Cooperative TURP Group Hines VA Cooperative Studies Program Coordinating Center, Hines, Illinois (P04) Advances in hardware design and the conversion of mainframe database management and statistical analysis software packages to the microcomputer environment have made it possible to perform all data processing for large clinical trials on a microcomputer. VA Cooperative Study #246 is designed to compare TURP surgery to medical follow-up in men over age 55 with moderately symptomatic benign prostatic hyperplasia. The study is being conducted at nine VA urology departments with a target sample size of 526 patients. The medical database will grow to 25,000 records. A medical resource utilization database is also being maintained for a costeffectiveness subprotocol and will contain over 50,000 records. All data processing, including data entry, database management and interim statistical analyses are being conducted on an IBM PC AT. This presentation focuses on the selection of hardware and software, systems design, and problems encountered that are unique to the microcomputer environment.