NDLI: Practical guide to understanding clinical research compliance.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Neely, J. Gail Paniello, Randal C. Graboyes, Evan M. Sharon, Jeffrey D. Grindler, David J. Nussenbaum, Brian
Spatial Coverage	United States
Description	Country affiliation: United States Author Affiliation: Neely JG ( Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St Louis, Missouri, USA.)
Abstract	Noncompliance with federal regulations, as monitored through institutional review boards for the ethical conduct of clinical research, can occur, even to seasoned investigators. The cause of this noncompliance can be that an investigator is overloaded, does not know the regulations, or does not take the time to pay attention to the details. Sometimes it happens just because of inevitable human error that can befall us all at any time. The authors begin by citing the inherent differences between clinical practice and clinical research. This is followed by an illustration of common noncompliance errors, with examples, followed by general and specific concepts and methods to minimize noncompliance events. The objective of this article is to condense the myriad details involved in conducting clinical research into a set of manageable recommendations that can be recalled easily before and during the research. The material supporting these recommendations comes from years of institutional review board work at several institutions and consultation with experienced principal investigators and their research coordinators.
File Format	HTM / HTML
ISSN	01945998
Issue Number	5
Volume Number	150
e-ISSN	10976817
Journal	Otolaryngology -- Head and Neck Surgery
Language	English
Publisher	SAGE Publications
Publisher Date	2014-05-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Ethics Informed Consent United States Ethics Committees, Research Humans Ethical Review Discipline Otolaryngology Legislation & Jurisprudence Government Regulation Biomedical Research Human Experimentation Journal Article
Content Type	Text
Resource Type	Article
Subject	Otorhinolaryngology Surgery

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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
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