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Human Investigation Committee
Yale University
School of Medicine
47 College Street,
Suite 204
New Haven, CT
06520-8010 USA
Phone:
(203) 785-4688
Fax:
(203) 785-2847
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Responsibilities of Sponsor Investigators
Investigators when designing research protocols which utilize a drug should consider whether an IND is required, or whether an IND exemption is appropriate prior to conducting the study.
Investigators should be fully aware of their obligations and responsibilities required by Yale University and the FDA prior to the filing of an IND application.
This site provides a summary of sponsor investigator responsibilities pertinent to data and document management. The summary should not be used as a substitute for thorough familiarity and compliance with applicable regulations and guidance. The documents are based on two primary references that all sponsor-investigators should be familiar with:
- Food and Drug Administration (FDA), 21 CFR Part 312, Investigational New Drug Application
- International Conference on Harmonization (ICH)-E6, Good Clinical Practice, Consolidated Guidance (PDF format)
Yale user ID and password required to access the summary.
Comments and feedback on the usefulness of this site and how HIC may further provide assistance to sponsor-investigators are welcomed.
Additional Assistance for Sponsor Investigators
For assistance in preparing for site monitoring or conducting a self assessment or in devising procedures to enhance compliance, contact the HIC Compliance Manager, Tracy Rightmer, J.D., or the Chair of HIC I, Sandra L. Alfano, Pharm.D, 785-4688.
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Last modified: Thursday, 31-Jan-2008 14:43:14 EST . (LMc)