Literature DB >> 12944237

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

B G Gordon1, A Kessinger, S L Mann, E D Prentice.   

Abstract

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.

Keywords:  Biomedical and Behavioral Research; Legal Approach

Mesh：

Year:  2003        PMID： 12944237     DOI： 10.1080/14653240310002225

Source DB:  PubMed          Journal:  Cytotherapy        ISSN： 1465-3249            Impact factor:   5.414


  4 in total

Review 1.  Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform.

Authors:  George Silberman; Katherine L Kahn
Journal:  Milbank Q       Date:  2011-12       Impact factor: 4.911

2.  Effects of Regulatory Support Services on Institutional Review Board Turnaround Times.

Authors:  Pankaja Desai; Priyanka Nasa; Jackie Soo; Cunhui Jia; Michael L Berbaum; James H Fischer; Timothy P Johnson
Journal:  J Empir Res Hum Res Ethics       Date:  2017-04-16       Impact factor: 1.742

3.  How to improve the implementation of academic clinical pediatric trials involving drug therapy? A qualitative study of multiple stakeholders.

Authors:  Delphine Girard; Olivier Bourdon; Hendy Abdoul; Sonia Prot-Labarthe; Françoise Brion; Annick Tibi; Corinne Alberti
Journal:  PLoS One       Date:  2013-05-28       Impact factor: 3.240

4.  Academic pediatric clinical research: factors associated with study implementation duration.

Authors:  Delphine Meier-Girard; Annick Tibi; Hendy Abdoul; Sonia Prot-Labarthe; Françoise Brion; Olivier Bourdon; Corinne Alberti
Journal:  BMC Med Res Methodol       Date:  2016-03-29       Impact factor: 4.615
  4 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.