NDLI: Data safety and monitoring for research involving remote health monitoring.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Kovach, Karen A. Aubrecht, Jill Ann Dew, Mary Amanda Myers, Brad Dabbs, Annette Devito
Description	Country affiliation: United States Author Affiliation: Kovach KA ( School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania 16105, USA. kak114@pitt.edu)
Abstract	Investigators conducting research involving human subjects are obligated to safeguard the wellbeing of the study participants. Other than requiring investigators to establish procedures for ongoing monitoring and reporting of adverse events, federal regulations do not dictate how human subject safety should be ensured. A variety of data safety monitoring (DSM) procedures may be acceptable depending on the nature, size, and complexity of the study. However, practical guidance for establishing and implementing appropriate DSM plans for such studies are lacking. In this article, we provide a review of the DSM considerations associated with monitoring health remotely and describe the Pocket Personal Assistant for Tracking Health project as an exemplar for how to develop effective DSM plans for research that captures clinical data using remote health-monitoring devices. Protecting the safety and welfare of participants is one of the most important mandates for research involving human subjects. Investigators have an ethical and scientific responsibility to monitor the safety of research participants. Investigators typically fulfill this responsibility by monitoring and reporting adverse events.
File Format	HTM / HTML
ISSN	15305627
e-ISSN	15563669
DOI	10.1089/tmj.2010.0219
Journal	Telemedicine and e-Health
Issue Number	7
Volume Number	17
Language	English
Publisher	Mary Ann Liebert, Inc.
Publisher Date	2011-09-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Discipline Medical Informatics Computer Security Confidentiality Electronic Health Records Human Experimentation Ethics Remote Consultation Medical Informatics Research Support, N.i.h., Extramural
Content Type	Text
Resource Type	Article
Subject	Health Information Management Health Informatics

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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