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Article: Data management and quality assurance

TitleData management and quality assurance
Authors
KeywordsClinical Data Management
Data Validation
Good Clinical Data Management Practice
Quality Assurance
Standard Operating Procedures
Issue Date2001
PublisherDrug Information Association. The Journal's web site is located at http://www.diahome.org/docs/Journal/DIAJournal_index.cfm?PageID=dijindex
Citation
Drug Information Journal, 2001, v. 35 n. 3, p. 839-844 How to Cite?
AbstractClinical data management is a vital vehicle in clinical trials to ensure the integrity and quality of data being transferred from trial subjects to a database system. Poor management of data is a pitfall to statisticians, study investigators, sponsors, and most importantly, patients. Efforts in quality assurance in clinical data management have been increasing, as reflected in the increase of related publications in MEDLINE during the past 10 years. Despite the success of harmonization of Good Clinical Practice (GCP) in Europe, Japan, and the United States, no harmonized guideline on good clinical data management is available yet. We attempt to examine the current regulatory requirements on clinical data management and to discuss specific issues in data acquisition and data validation consistent with good clinical data management. In summary, good clinical data management currently means compliance with International Conference on Harmonization (ICH) GCP and Food and Drug Administration (FDA) guidelines. The three most important concepts for good clinical data management are implementation of quality control procedures, an audit trail, and quality quantification of the final database. They should all be dictated in standard operating procedures that are continually updated to the current best practice.
Persistent Identifierhttp://hdl.handle.net/10722/178266
ISSN
2014 Impact Factor: 0.5
2015 SCImago Journal Rankings: 0.252
References

 

DC FieldValueLanguage
dc.contributor.authorFong, DYTen_US
dc.date.accessioned2012-12-19T09:44:53Z-
dc.date.available2012-12-19T09:44:53Z-
dc.date.issued2001en_US
dc.identifier.citationDrug Information Journal, 2001, v. 35 n. 3, p. 839-844en_US
dc.identifier.issn0092-8615en_US
dc.identifier.urihttp://hdl.handle.net/10722/178266-
dc.description.abstractClinical data management is a vital vehicle in clinical trials to ensure the integrity and quality of data being transferred from trial subjects to a database system. Poor management of data is a pitfall to statisticians, study investigators, sponsors, and most importantly, patients. Efforts in quality assurance in clinical data management have been increasing, as reflected in the increase of related publications in MEDLINE during the past 10 years. Despite the success of harmonization of Good Clinical Practice (GCP) in Europe, Japan, and the United States, no harmonized guideline on good clinical data management is available yet. We attempt to examine the current regulatory requirements on clinical data management and to discuss specific issues in data acquisition and data validation consistent with good clinical data management. In summary, good clinical data management currently means compliance with International Conference on Harmonization (ICH) GCP and Food and Drug Administration (FDA) guidelines. The three most important concepts for good clinical data management are implementation of quality control procedures, an audit trail, and quality quantification of the final database. They should all be dictated in standard operating procedures that are continually updated to the current best practice.en_US
dc.languageengen_US
dc.publisherDrug Information Association. The Journal's web site is located at http://www.diahome.org/docs/Journal/DIAJournal_index.cfm?PageID=dijindexen_US
dc.relation.ispartofDrug Information Journalen_US
dc.subjectClinical Data Managementen_US
dc.subjectData Validationen_US
dc.subjectGood Clinical Data Management Practiceen_US
dc.subjectQuality Assuranceen_US
dc.subjectStandard Operating Proceduresen_US
dc.titleData management and quality assuranceen_US
dc.typeArticleen_US
dc.identifier.emailFong, DYT: dytfong@hku.hken_US
dc.identifier.authorityFong, DYT=rp00253en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.scopuseid_2-s2.0-0034840459en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-0034840459&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume35en_US
dc.identifier.issue3en_US
dc.identifier.spage839en_US
dc.identifier.epage844en_US
dc.publisher.placeUnited Statesen_US
dc.identifier.scopusauthoridFong, DYT=35261710300en_US

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