Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Workshop Report (1999) / Chapter Skim
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Pages 13-25
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13 Presubmission and Submission DATA COLLECTION Presented by John R Schultz, Ph.D.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS14 Comprehensive Data Management and Analysis Plan Elements of a data management and analysis plan include an annotated case report form with instructions on how to complete and code the form, a data entry manual, and a flowchart that describes the location and custodian of the data. A list of data variables, an analysis grid, and samples of the tables and graphics used for data presentation should also be available.
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PRESUBMISSION AND SUBMISSION 15 first set of case report forms has been completed, the data flow is reviewed to reduce the likelihood of errors. The results of the review are shared with collaborating sites.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS16 force the contact between personnel at the different study sites. Document sharing and interactive voice recognition are other enabling technologies.
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PRESUBMISSION AND SUBMISSION 17 into the field to make sure that sites are properly initiated and that data are collected appropriately.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS18 tional agents and has up to 1,000 treatment trials, accruing over 20,000 new patients each year into studies at thousands of sites with thousands of investigators. In 1978, NCI filed quality control procedures with the Food and Drug Administration (FDA)
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PRESUBMISSION AND SUBMISSION 19 and contracts with a clinical trials monitoring service to audit its cancer centers and selected grantees. NCI spends an additional $575,000 on CCTG audits, $193,000 on auditing Phase 1 clinical trials, and $104,000 on audits of Phase 2 and select Phase 3 clinical trials.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS20 documentation on data-handling plans, data inconsistencies, and agreement changes. FDA verifies these data using individuals with expertise in several areas: medical reviewers, statisticians, and auditors.
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PRESUBMISSION AND SUBMISSION 21 specialists from both industry and FDA are important means to developing a common understanding of the requirements and processes that are acceptable to both. These efforts will prompt trust and achieve a common goal: production of a quality report with well-documented proof of safety and efficacy.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS22 FDA and more recently the International Committee on Harmonization (ICH) , have issued documents that provide guidance on the preparation of an NDA (Code of Federal Regulations, [21CFR 201, 312, 314, 600, 601]
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PRESUBMISSION AND SUBMISSION 23 1. The intent of medical records is to provide a factual account of a subject's response and therapy.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS24 tory practices and cross-training of personnel from different quality assurance (QA) groups are approaches undertaken by most companies.
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PRESUBMISSION AND SUBMISSION 25 tion of the process. Such a report could identify the nature of errors and their impacts on the outcome of the study and could be used to make theories about the impacts of undetected errors.
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