R. Saravana Kumar, Jayam College of Engineering and Technology, Dharmapuri, Tamilnadu, India.
G. Tholkappia Arasu, AVS Engineering College, Salem, Tamilnadu, India.
DOI : 01.0401/ijaict.2014.06.12
International Journal of Advanced Information and Communication Technology
Received On : May 10, 2016
Revised On : June 20, 2016
Accepted On : July 15, 2016
Published On : August 05, 2016
Volume 03, Issue 08
Pages : 528-533
Abstract
Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. With the implementation of regulatory compliant data management tools, CDM team can meet these demands. Additionally, it is becoming mandatory for companies to submit the data electronically. CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. This article highlights the processes involved and provides the reader an overview of the tools and standards adopted as well as the roles and responsibilities in CDM.
Keywords
Cluster-Based WSNS, Id-Based Digital Signature, Id-Based Online/Offline Digital Signature, Secure Data Transmission Protocol.
Cite this article
R. Saravana Kumar, G. Tholkappia Arasu, “Data Management and Data Analysis Interoperability in Medical Research” INTERNATIONAL JOURNAL OF ADVANCED INFORMATION AND COMMUNICATION TECHNOLOGY, pp.528-533, August 05, 2016.
Copyright
© 2016 R. Saravana Kumar, G. Tholkappia Arasu. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.