An outline of data management in clinical research
Clinical data management (CDM) is an indispensable part of clinical research. CDM activities lead to the collection of reliable, high-quality and statistically sound data generating from the clinical trials. Several studies suggest that such data helps in extreme reduction in time from drug development processes to the marketing stage. Several practices in CDM including CRF annotation, case report form (CRF) designing, data extraction, data entry, data validation, database designing, database locking, discrepancy management and medical coding are evaluated for quality checks at regular intervals during clinical trial. In recent times, the huge gap about improvements of the CDM standards for meeting the regulatory requirements remains to be filled. Fulfilling these requirements will help the clinical trial sector to stay ahead of the game. The current article accentuates the practices followed and activities involved in CDM. Therefore, it enables the reader an outline of management of data in the clinical research.
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. Trials. 2010;11:79.
Gerritsen MG, Sartorius OE, vd Veen FM, Meester GT. Data management in multi-center clinical trials and the role of a nation-wide computer network. A 5 year evaluation. Proc Annu Symp Comput Appl Med Care.1993:659-62.
Lu Z, Su J. Clinical data management: Current status, challenges, and future directions from industry perspectives. Open Access J Clin Trials. 2010;2:93-105.
Roderick J, D'Agostino R, Cohen ML, Dickersin K, Emerson SS, John T. The Prevention and Treatment of Missing Data in Clinical Trials. New Eng J Med. 2012;367:1355-60.
Tai BC, Seldrup J. A review of software for data management, design and analysis of clinical trials. Ann Acad Med Singapore. 2000;29(5):576-81.
Study Data Tabulation Model. Texas: Clinical Data Interchange Standards Consortium.; c2011. Available at http://www.cdisc.org/sdtm. Accessed on 1 October 2016.
CDASH. Texas: Clinical Data Interchange Standards Consortium. c2011. Available at http://www.cdisc.org/cdash. Accessed on 8 October 2016.
Cummings J, Masten J. Customized dual data entry for computerized data analysis. Qual Assur. 1994;3:300-3.
Reynolds-Haertle RA, McBride R. Single vs. double data entry in CAST. Control Clin Trials. 1992;13:487-94.
Babre D. Medical Coding in Clinical Trials. Perspect Clin Res. 2010;1(1):29–32.
Elizabeeth Ness, Clinical data management Centre for Cnacer Research National Cancer Institute. Available at https://ccrod.cancer.gov/confluence/
display/CCRCRO/CCR+Orientation. Accessed on 15 October 2016.
Rondel RK, Varley SA, Webbs CF. Clinical Data Management. 2nd edition. Wiley Publications; 1993.