Volume : 10, Issue : 01, January – 2023

Title:

36.A REVIEW ON DATA MANAGEMENT IN CLINICAL RESEARCH

Authors :

Pradip Ganesh Landge*, Saiprasad Narayan Dachawar, Chetan Shivaji Salgude, Dr. Sameer Shafi, Vishweshwar Dharashive

Abstract :

Clinical Data Management (CDM) could be a crucial innovative clinical analysis, that ends up in the generation of high-quality, reliable, and statistically sound information from clinical trials. This helps to provide a forceful reduction in time from drug development to promotion. Team members of CDM square measure actively concerned altogether stages of trial right from origination to completion. they must have adequate method data that helps maintain the standard standards of CDM processes. varied procedures in CDM as well as Case Report From (CRF) coming up with, CRF annotation, info coming up with, data-entry, information validation, discrepancy management, medical committal to writing, information extraction, and info protection square measure assessed for quality at regular intervals throughout an effort. within the gift situation, theirs is an exaggerated demand to enhance the CDM standards to fulfill the regulative necessities and keep them before the competition by suggests that of quicker commercialization of the product. With the implementation of regulative compliant information management tools, the CDM team will meet these demands. Clinical information Management has to draw on a broad variety of skills like technical, scientific, project management, data technology, and systems engineering to offer valued service in managing information at intervals of the anticipated e-clinical age.
KEY WORDS: Clinical data, clinical data management systems, data management, e-CRF, validation, data entry, discrepancy management.

Cite This Article:

Please cite this article in press Pradip Ganesh Landge et al, A Review On Data Management In Clinical Research., Indo Am. J. P. Sci, 2023; 10(01)./p>

Number of Downloads : 10

References:

1. N. G. Forouhi and N. J. Wareham, “Epidemiology of diabetes,” Medicine,2019; 47(1): 22 27.
2. 2. F. M. Puchulu, “Definition, diagnosis and classification of diabetes mellitus,” in Dermatology and Diabetes, Springer Cham,2018; 7–18.
3. CFR – Code of Federal Regulations Title 21 [Internet]. Maryland: Food and Drug Administration; Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfcfr/CFRSearch.cfm?fr=11.10. [Updated 2010 Apr 4; Cited 2011 Mar 1].
4. Study Data Tabulation Model [Internet]. Texas: Clinical Data Interchange Standards Consortium.; c2011. Available from: http://www.cdisc.org/sdtm. [Updated 2007 Jul; Cited 2011 Mar 1].
5. CDASH [Internet]. Texas: Clinical Data Interchange Standards Consortium.; c2011. Available from: http://www.cdisc.org/cdash. [Updated 2011 Jan; Cited 2011 Mar 1].
6. Fegan GW, Lang TA. Could an open-source clinical trial data-management system be what we have all been looking for? PLoS Med 2008;5:e6.
7. Kuchinke W, Ohmann C, Yang Q, Salas N, Lauritsen J, Gueyffier F, et al. Heterogeneity prevails: The state of clinical trial data management in Europe – results of a survey of ECRIN centres. Trials 2010;11:79.
8. Cummings J, Masten J. Customized dual data entry for computerized data analysis. Qual Assur 1994;3:300-3.
9. Reynolds-Haertle RA, McBride R. Single vs. double data entry in CAST. Control Clin Trials 1992;13:487-94.
10. Gerritsen MG, Sartorius OE, Veen FM, Meester GT. Data management in multicenterclinical trials and the role of a nationwide computer network. Med Care.1993;659–62.
11. Lu Z, Su J. Clinical data management: Current status, challenges, and future directions from industry perspectives. J Clin Trials.2010, 2:93–105.
12. Haux R, Knaup P, Leiner F. On educating about medical data management – the other side of the electronic health record. Methods Inf Med 2007;46:74