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Overview of global clinical data management regulations and standards

Liu, D.

Yao Xue Xue Bao 50(11): 1443-1451

2015

ISSN/ISBN: 0513-4870
PMID: 26911040
Document Number: 683931
Quality and integrity of clinical trials and associated data management is a basis on the scientific and rightly assessments of drug safety and efficacy. While both normalization and standardization of clinical trial procedures assure quality of clinical trials and the relevant data processes, they will drive and improve the efficiency and reliability of real-world deliverables in clinical trials in turn. Currently, the comprehensive standards and practices of clinical trials and associated data management are globally established better, and US and EMA have enacted and implemented adequate guidances and regulations well. China is in the initial stage of development of relevant regulations regarding clinical trials and associated data management. This review will focus on the above-mentioned global regulations and standards of clinical data management in the views of good clinical data management standpoints, making references to improve the Chinese regulative system of clinical data management.

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Heitmann, K.U.; Schweiger, R.; Dudeck, J. 2002: Discharge and referral data exchange using global standards--the SCIPHOX project in Germany Studies in Health Technology and Informatics 90: 679-684
Haire, B.G.; Folayan, M.Oluwatoyin.; Brown, B. 2014: Standards and guidelines for HIV prevention research: considerations for local context in the interpretation of global ethical standards African Journal of Reproductive Health 18(3 Spec No): 55-65
Ott, W.E. 2003: Electronic and data management issues: global positioning system and EMS Jems: a Journal of Emergency Medical Services 28(8): 94-97
Jeff Burton; Lou DiBerardinis; Jack Price; Mili Mavely 2008: Standards of good practice: Overview of ANSI Z9 ventilation standards with emphasis on ANSI/AIHA Z9.2-2006: Fundamentals governing the design and operation of LEV systems Journal of Chemical Health and Safety 15(3): 4-8
Birkner, J. 2017: The Status of Current Respirator Regulations and Standards Occupational Health and Safety 86(5): 14; 16, 18
Guillot, M.; Gerland, P.; Pelletier, F.ço.; Saabneh, A. 2012: Child mortality estimation: a global overview of infant and child mortality age patterns in light of new empirical data Plos Medicine 9(8): E1001299
Guillot, M.; Gerland, P.; Pelletier, F.ço.; Saabneh, A. 2012: Child mortality estimation: a global overview of infant and child mortality age patterns in light of new empirical data Plos Medicine 9(8): E1001299
Guillot, M.; Gerland, P.; Pelletier, F.ço.; Saabneh, A. 2012: Child mortality estimation: a global overview of infant and child mortality age patterns in light of new empirical data Plos Medicine 9(8): E1001299
Guillot, M.; Gerland, P.; Pelletier, F.ço.; Saabneh, A. 2012: Child mortality estimation: a global overview of infant and child mortality age patterns in light of new empirical data Plos Medicine 9(8): E1001299
Baumgarten, H.J. 1977: Food regulations as regulations to which penalties are attached before and after their transfer to the sphere of regulations governing illegal actions Fleischwirtschaft 57(11): 1984-1988
Chadwick, P.; Taherinejad, F.; Hamberg, K.; Waring, M. 2009: Clinical and scientific data on a silver-containing soft-silicone foam dressing: an overview Journal of Wound Care 18(11): 483
Benson, M.; Junger, A.; Quinzio, L.; Michel, A.; Sciuk, G.; Fuchs, C.; Marquardt, K.; Hempelmannn, G. 2000: From data entry to data presentation at a clinical workstation--experiences with Anesthesia Information Management Systems (AIMS) Zeitschrift für Arztliche Fortbildung und Qualitatssicherung 94(7): 613-619
Dove, E.S.; Taylor, M.J. 2021: Signalling Standards for Progress: Bridging the Divide Between a Valid Consent to use Patient Data Under Data Protection Law and the Common Law Duty of Confidentiality Medical Law Review 29(3): 411-445
Rosenberger, R. 2007: Changes in clinical standards and the need for adjusting legal standards of care from the point of view of civil law Zeitschrift für Arztliche Fortbildung und Qualitatssicherung 101(8): 537-540
Cornu, C.; Donche, A.; Coffre, C.; Le Gouge, Aélie.; Rym, B.; Vaugier, I.; Barbot, Fédéric.; Leizorovicz, A.; Juge, N.; Giraud, Céline.; Gueyffier, Fçois.; Félin, A.; Mura, T.; Chevassus, H.; Binquet, C. 2016: ECRIN standard requirements for good clinical practices-compliant data management in multinational clinical trials Therapie 2016
Kelley, E.; Geslin, C.; Djibrina, S.; Boucar, M. 2001: Improving performance with clinical standards: the impact of feedback on compliance with the integrated management of childhood illness algorithm in Niger, West Africa International Journal of Health Planning and Management 16(3): 195-205
Kelley, E.; Geslin, C.; Djibrina, S.; Boucar, M. 2001: Improving performance with clinical standards: the impact of feedback on compliance with the integrated management of childhood illness algorithm in Niger, West Africa International Journal of Health Planning and Management 16(3): 195-205
Kondrachine, A.V.; Trigg, P.I. 1997: Global overview of malaria Indian Journal of Medical Research 106: 39-52
Fowler, J.L.; Ruckh, P.B.; Murnane, T.G. 1974: A computerized food microbiologic data collection program and its potential in formulating data for microbiologic standards Journal of the American Veterinary Medical Association 165(11): 1000-1002
Morin, K.H.; Yan, J. 2007: Developing global standards for initial nursing and midwifery education Journal of Obstetric Gynecologic and Neonatal Nursing: Jognn 36(3): 201-202