Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency-Reference-Cited by-同舟云学术

Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

Published:2016-07 Issue:4 Volume:50 Page:480-486
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Arango Jaime,Chuck Tina,Ellenberg Susan S.,Foltz Bridget,Gorman Colleen,Hinrichs Heidi,McHale Susan,Merchant Kunal,Seltzer Jonathan,Shapley Stephanie,Wild Gretchen

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479016635220.pdf

Reference47 articles.

1. US Department of Health and Human Services. Guidance for Industry. E6 Good Clinical Practice: Consolidated Guidance. International Conference on Harmonisation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf. Published April 1996. Accessed March 11, 2014.

2. US Department of Veterans Affairs. Options for fulfilling Office of Research and Development (ORD) training requirements. http://www.research.va.gov/pride/training/options.cfm. Accessed September 16, 2015.

3. National Institute of Allergy and Infectious Diseases (NIAID). Good Clinical Practice training for NIAID and awardee clinical research staff. https://www.niaid.nih.gov/LabsAndResources/resources/toolkit/Documents/NIAIDGCPTrainingPolicy.pdf. Accessed September 16, 2015.

4. Division of Acquired Immunodeficiency Syndrome (DAIDS). Human Subjects Protection (HSP) and Good Clinical Practice (GCP) training requirements. https://www.niaid.nih.gov/LabsAndResources/resources/toolkit/Documents/gcp_hsp_sitetrain_policy.pdf. Accessed September 16, 2015.

5. Clinical Trials Transformation Initiative. GCP training expert meeting. http://www.ctti-clinicaltrials.org/what-we-do/ctti-projects/gcp-training/expert-meeting. Accessed November 23, 2015.

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