Document Detail


Ensuring data quality in a multicenter clinical trial: remote site data entry, central coordination and feedback.
MedLine Citation:
PMID:  2697015     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
In an ongoing multicenter clinical trial, "Treatment Strategies in Schizophrenia," the five participating sites have the capacity to perform a variety of tasks or study functions independently. These tasks include (a) verification of diagnostic eligibility through the use of computerized decision algorithms; (b) assignment of patients to treatment based on prognostic indicators using a computerized randomization algorithm; (c) entry of data into a microcomputer using a clinical trial data management system that performs simple range and missing data item checks; and (d) regular transfer of all data to the central coordinating team. The clinical trial data management system employed allows for both independent site functioning and assurance of consistency across sites. The integration of a variety of software outside the main data management system provides the central coordinators with the tools to monitor critical data as it is collected, as well as the capacity to assess the flow, quality, and uniformity of the ongoing trial.
Authors:
J B Severe; N R Schooler; J H Lee; G Haas; K T Mueser; P Rosen; D Shortell; M Shumway
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  Psychopharmacology bulletin     Volume:  25     ISSN:  0048-5764     ISO Abbreviation:  Psychopharmacol Bull     Publication Date:  1989  
Date Detail:
Created Date:  1990-04-04     Completed Date:  1990-04-04     Revised Date:  2009-11-11    
Medline Journal Info:
Nlm Unique ID:  0101123     Medline TA:  Psychopharmacol Bull     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  488-90     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Clinical Trials as Topic
Humans
Multicenter Studies as Topic
Quality Control
Research Design
Schizophrenia / therapy*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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