The impact of escalating regulatory requirements on the conduct of clinical research

Autor:	S. L. Mann, Anne Kessinger, Bruce Geoffrey Gordon, Ernest D. Prentice
Rok vydání:	2003
Předmět:	Cancer Research Biomedical Research media_common.quotation_subject Immunology MEDLINE Guidelines as Topic Academic institution Government regulation Political science Institution Adverse Drug Reaction Reporting Systems Humans Immunology and Allergy Genetics (clinical) media_common Clinical Trials as Topic Transplantation Informed Consent Conflict of Interest United States Food and Drug Administration business.industry Cell Biology Public relations Institutional review board United States Human Experimentation Clinical research Oncology Government Regulation United States Dept. of Health and Human Services Clinical Trials Data Monitoring Committees business Administration (government)
Zdroj:	Cytotherapy. 5:309-313
ISSN:	1465-3249
DOI:	10.1080/14653240310002225
Popis:	A discussion of the impact of escalating regulatory requirements is provided, from the point of view of the administration of the institutional review board of an academic institution, and from clinical investigators who conduct studies at that same institution. Current and anticipated future issues are discussed.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a3ea988f3824856718f7baf5906aeb49 https://doi.org/10.1080/14653240310002225 Zobrazit plný text záznamu Full Text from ScienceDirect Plný text ve formátu PDF