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P24 a quality assurance monitoring system: The national cancer institute clinical cooperative oncology group experience
125s
Abstracts P24
A QUALITY ASSURANCE MONITORING SYSTEM: TEIE NATIONAL CANCER INSTITUTE CLINICAL COOPERATIVE ONCOLOGY GROUP EXPERIENCE Gary Smith, Joan Mauer and Richard Mowery National Cancer Institute Bethesda, Maryland
The National Cancer Institute @ICI) sponsors approximately 200 active INDs of antineoplastic agents at any given time. The bulk of the extramural clinical trials of investigational agents are conducted through the eleven Clinical Cooperative Oncology Groups. In 1982, with the approval of the Food and Drug Administration, the NC1 delegated its responsibility for monitoring investigational agent studies to the cooperative groups but retained direct oversight of each group’s quality assurance program. The NC1 monitoring guidelines require that each cooperative group conduct a quality assurance audit of its members at least once every thirty six months. During the quality assurance audits, assessments of compliance with regulatory requirements, protocol adherence, and verification of reported data are made. In February 1995, the Clinical Trials Monitoring Branch (CTMB) implemented revised Guidelines for On-site Monitoring of Clinical Trials for Cooperative Groups and CCOP Research Bases. In October 1995, a computerized system for scheduling, tracking and reporting findings of the cooperative group audits was implemented. This computer system standardized the format for reporting cooperative group audit findings and resulted in improved scheduling, monitoring and follow-up of audit fmdings by CTMB staff. The computerized audit system will be described, and the findings since the introduction of the computerized system will be detailed. The findings will include frequency of deficiencies involving the various categories reviewed during the audit: Institutional Review Board review, informed consent, protocol eligibility, treatment administration, response assessment, toxicity evaluation, and general data quality.
PEACE AUTOMATED RANDOMIZATION AND DRUG ASSIGNMENT SYSTEM Carol L. Fye, Mark S. Jones, William II. Gagne, Joel Verter, and Patricia Cleary for the PEACE Study Group VA Cooperative Studies Program Albuquerque, New Mexico
The Department of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (PCC) designed and installed an automated randomization and drug assignment system for use in the NHLBI PEACE (“Prevention of Events with Angiotensin Converting Enzyme Inhibitors’) Trial. The system allows authorized personnel to access an 800 number, using a touch-tone telephone, to randomize patients and obtain routine as well as emergency drug assignments 24 hours/day, 7 day/week from any of the more than 140 participating clinical centers throughout the United States and Canada. The randomization process collects demographic data, verifies patient eligibility, and assigns a randomization code. Patients are randomized to one of two strata: prior history of an myocardial infarction (MI) or documented obstructive coronary artery disease with or without an MI. When randomized each patient is automatically assigned two drug therapy kits from the available study drug supply at their clinical center. For routine and emergency drug assignments, authorized clinic personnel key in the number of kits and the strength required for a specific patient. After each drug therapy kit is assigned, the caller is required to correctly enter the kit ID number for verification. As kits are assigned, the computer system
Abstracts P24
A QUALITY ASSURANCE MONITORING SYSTEM: TEIE NATIONAL CANCER INSTITUTE CLINICAL COOPERATIVE ONCOLOGY GROUP EXPERIENCE Gary Smith, Joan Mauer and Richard Mowery National Cancer Institute Bethesda, Maryland
The National Cancer Institute @ICI) sponsors approximately 200 active INDs of antineoplastic agents at any given time. The bulk of the extramural clinical trials of investigational agents are conducted through the eleven Clinical Cooperative Oncology Groups. In 1982, with the approval of the Food and Drug Administration, the NC1 delegated its responsibility for monitoring investigational agent studies to the cooperative groups but retained direct oversight of each group’s quality assurance program. The NC1 monitoring guidelines require that each cooperative group conduct a quality assurance audit of its members at least once every thirty six months. During the quality assurance audits, assessments of compliance with regulatory requirements, protocol adherence, and verification of reported data are made. In February 1995, the Clinical Trials Monitoring Branch (CTMB) implemented revised Guidelines for On-site Monitoring of Clinical Trials for Cooperative Groups and CCOP Research Bases. In October 1995, a computerized system for scheduling, tracking and reporting findings of the cooperative group audits was implemented. This computer system standardized the format for reporting cooperative group audit findings and resulted in improved scheduling, monitoring and follow-up of audit fmdings by CTMB staff. The computerized audit system will be described, and the findings since the introduction of the computerized system will be detailed. The findings will include frequency of deficiencies involving the various categories reviewed during the audit: Institutional Review Board review, informed consent, protocol eligibility, treatment administration, response assessment, toxicity evaluation, and general data quality.
PEACE AUTOMATED RANDOMIZATION AND DRUG ASSIGNMENT SYSTEM Carol L. Fye, Mark S. Jones, William II. Gagne, Joel Verter, and Patricia Cleary for the PEACE Study Group VA Cooperative Studies Program Albuquerque, New Mexico
The Department of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (PCC) designed and installed an automated randomization and drug assignment system for use in the NHLBI PEACE (“Prevention of Events with Angiotensin Converting Enzyme Inhibitors’) Trial. The system allows authorized personnel to access an 800 number, using a touch-tone telephone, to randomize patients and obtain routine as well as emergency drug assignments 24 hours/day, 7 day/week from any of the more than 140 participating clinical centers throughout the United States and Canada. The randomization process collects demographic data, verifies patient eligibility, and assigns a randomization code. Patients are randomized to one of two strata: prior history of an myocardial infarction (MI) or documented obstructive coronary artery disease with or without an MI. When randomized each patient is automatically assigned two drug therapy kits from the available study drug supply at their clinical center. For routine and emergency drug assignments, authorized clinic personnel key in the number of kits and the strength required for a specific patient. After each drug therapy kit is assigned, the caller is required to correctly enter the kit ID number for verification. As kits are assigned, the computer system