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Excellence Award“Most Successful Company or Programme of the Year in Raising GCP Standards” category  \nSociety for Clinical Data Management  \nGood Clinical Data Management Practices  \nPublished October 2013  \n“The need for Good Clinical Data Management Practices is not new. In the early 1970s, the Public Health Service recognized this need through a contract to a major research university for training of research data managers. However, the need continues, the need changes over time, and the need for good clinical data management practices has become even more important as biopharmaceutical and medical device industry and regulatory bodies rely more and more heavily on the evaluation of electronically transmitted clinical trials data for critical data-based decision making.”  \nThus, the Society for Clinical Data Management provides the Good Clinical Data Management Practices to the SCDM membership.  \nThis document constitutes neither consensus nor endorsement by regulatory agencies, pharmaceutical or biotech companies, contract research organizations or the academic community, but rather reflects the current views of SCDM membership. Additionally, none of the recommendations contained herein supersede regulations or regulatory guidelines, which should always be consulted prospectively to assure compliance. The document should not be considered  \nan exhaustive list of topics.  \nThis page is intentionally blank.  \nGCDMP Revision History  \n\n| Publication Date | Comments |\n| --- | --- |\n| September 2000 | Initial publication of the GCDMP with the following chapters: Assuring Data Quality; Data Acquisition; Data Entry and Data Processing; Data Storage; Database Closure; Database Validation, Programming and Standards; Laboratory and Other External Data; Measuring Data Quality; Safety Data Management and Reporting; Vendor Management; Glossary. |\n| January 2002 | The following chapters added to the GCDMP: CDM Presentation at Investigator Meetings; CRF Printing and Vendor Selection; Preparation and Preservation of CRF Completion Guidelines; Serious Adverse Event Data Reconciliation; Training.\u003Cbr>Data Entry and Data Processing chapter revised. |\n| September 2003 | The following chapters added to the GCDMP: Clinical Data Archiving; Data Privacy; Dictionary Management; Electronic Data Capture Principles. |\n| October 2005 | Metrics chapter revised. |\n| May 2007 | All chapters revised for consistency of style, grammar, and clarity. Substance of chapter content unchanged. |\n| July 2008 | All chapters revised with new headers, footers and pagination. The following chapters were revised for content, style, grammar and clarity: Serious Adverse Event Data Reconciliation; CRF Completion Guidelines; Clinical Data Archiving, CDM Presentation at Investigator Meetings, Vendor Management.. |\n| September 2008 | The following chapters added to the GCDMP: Electronic Data Capture—Concepts and Study Start-up; Electronic Data Capture—Study Conduct; Electronic Data Capture—Study Closeout.\u003Cbr>Measuring Data Quality chapter revised for content, style, grammar and clarity. |\n| December 2008 | The following chapter added to the GCDMP: Data Management Plan. |\n| March 2009 | Database Validation, Programming and Standards chapter revised for content, style, grammar and clarity. |\n| April 2009 | Data Privacy chapter revised for content, style, grammar and clarity. |\n| May 2009 | Dictionary Management chapter revised for content, style, grammar and clarity and renamed Medical Coding Dictionary Management and Maintenance. |\n| July 2009 | The following chapters added to the GCDMP: Patient-Reported Outcomes; Data Management Standards in Clinical Research. |\n| October 2009 | The following chapter added to the GCDMP: Laboratory Data Handling.\u003Cbr>Data Entry and Data Processing chapter revised for content, style, grammar and clarity and renamed Data Entry Processes\u003Cbr>Laborato","cbCaipCs2pPCTce7","https://ap.wps.com/l/cbCaipCs2pPCTce7","pdf",2423506,524,"English","# Contents\n## Executive Summary\n## Acknowledgements\n## Introduction\n## Data Privacy\n## Data Management Plan\n## Project Management for the Clinical Data Manager","[{\"question\":\"What is the purpose of Good Clinical Data Management Practices in the October 2013 edition?\",\"answer\":\"It provides guidance on the need for and value of good clinical data management practices, especially as electronic clinical trial data becomes central to critical decision making.\"},{\"question\":\"Does the document act as a regulatory endorsement or consensus?\",\"answer\":\"No. It states the views reflect SCDM membership and neither constitutes consensus nor endorsement by regulatory agencies or related organizations.\"},{\"question\":\"Do the recommendations override regulations or regulatory guidelines?\",\"answer\":\"No. The document notes that none of its recommendations supersede regulations or regulatory guidelines, which should be consulted to ensure compliance.\"}]","Good Clinical Data Management Practices - October 2013 Edition | PDF",1789642851,1320]