
[Federal Register: September 21, 2010 (Volume 75, Number 182)]
[Notices]               
[Page 57472]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se10-68]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0456]

 
Clinical Investigator Training Course

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA), Office of Critical 
Path Programs, in cosponsorship with the Clinical Trials Transformation 
Initiative (CTTI), is announcing a 3-day training course for health 
care professionals responsible for, or involved in, the conduct and/or 
design of clinical trials (clinical investigators). This course is 
intended to assist clinical investigators in understanding what 
preclinical and clinical information is needed to support the 
investigational use of medical products, as well as the scientific, 
regulatory, and ethical considerations involved in the conduct of 
clinical trials.

DATES:  The training course will be held on November 8 and 9, 2010, 
from 8 a.m. to 5 p.m. and on November 10, 2010, from 8 a.m. to 3 p.m.

ADDRESSES:  The training course will be held at the National Labor 
College, 10000 New Hampshire Ave., Silver Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Nancy Masiello, Office of Critical 
Path Programs, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, rm. 4166, Silver Spring, MD 20993-0002, 301-796-8498, 
Nancy.Masiello@fda.hhs.gov.
    Registration: Register by November 1, 2010, at the registration/
information Web site at https://www.trialstransformation.org/fda-
clinical-investigator-training-course/. Registration materials, payment 
procedures, accommodation information, and a detailed description of 
the course can be found at the registration/information Web site. The 
registration fee is $350 per person. The fee includes course materials 
and onsite lunch. Early registration is recommended because seating is 
limited. There will be no onsite registration. Persons attending the 
course are advised that FDA is not responsible for providing access to 
electrical outlets. If you need special accommodations due to a 
disability, please contact Nancy Masiello at least 7 days in advance.

SUPPLEMENTARY INFORMATION: Clinical trial investigators play a critical 
role in the development of medical products. They bear the 
responsibility for ensuring the safe and ethical treatment of study 
subjects and for acquiring adequate and reliable data to support 
regulatory decisions. This course is intended to assist clinical 
investigators in understanding what preclinical and clinical 
information is needed to support the investigational use of medical 
products, as well as the scientific, regulatory, and ethical 
considerations involved in the conduct of clinical trials.
    The training course is designed to provide clinical investigators 
with an overview of the following topics:
     The essential toxicological, pharmacological, and 
manufacturing data to support investigational use in humans;
     Fundamental issues in the design and conduct of clinical 
trials;
     Statistical and analytic considerations in the 
interpretation of trial data;
     Appropriate safety evaluation during studies;
     The ethical considerations and regulatory requirements for 
clinical trials; and
     Application and compliance issues.
    In addition, the course should:
     Foster a cadre of clinical investigators with knowledge, 
experience, and commitment to investigational medicine;
     Promote communication between clinical investigators and 
FDA;
     Enhance investigators' understanding of FDA's role in 
experimental medicine; and
     Improve the quality of data while enhancing subject 
protection in the performance of clinical trials.
    On November 8, 2010, the course will address the role of FDA in 
clinical studies, regulatory considerations for clinical trials, and 
review of the material generally appearing in an ``investigator's 
brochure,'' i.e., the preclinical information (toxicology, animal 
studies, and chemistry/manufacturing information) that supports initial 
clinical trials in humans. Presentations will also discuss the role of 
clinical pharmacology in early clinical studies and how this 
information is used in the design of subsequent studies. On November 9, 
2010, the course will include discussions of scientific, statistical, 
ethical, and regulatory aspects of clinical studies. On November 10, 
2010, the course will include discussions of safety assessment in 
clinical trials, including hepatic and cardiovascular safety, 
approaches to special populations (e.g., pregnant women and 
pediatrics), and breakout sessions to discuss how to put together an 
application, including related compliance issues.

    Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23493 Filed 9-20-10; 8:45 am]
BILLING CODE 4160-01-S

