[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Pages 45577-45578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19149]



Food and Drug Administration

[Docket No. FDA-2011-N-0523]

Clinical Investigator Training Course

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA), Office of Critical 
Path Programs and the Clinical Trials Transformation Initiative (CTTI) 
are cosponsoring a 3-day training course for clinical investigators on 
scientific, ethical, and regulatory aspects of clinical trials. This 
training course is intended to provide investigators with expertise in 
the design, conduct, and analysis of clinical trials; improve the

[[Page 45578]]

quality of clinical trials; and enhance the safety of trial 
participants. Senior FDA staff will communicate directly with clinical 
investigators on issues of greatest importance for successful clinical 
    Date and Time: The training course will be held on November 7 and 
8, 2011, from 8 a.m. to 5 p.m., and on November 9, 2011, from 8 a.m. to 
3:30 p.m.
    Location: The course will be held at the National Labor College, 
10000 New Hampshire Ave., Silver Spring, MD 20903-0002.
    Contact Person: Leonard Sacks, Office of Critical Path Programs, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 
4174, Silver Spring, MD 20993, 301-796-8502.
    Registration: Register by October 21, 2011. The registration fee is 
$400 per person. The fee includes course materials and onsite lunch. 
Early registration is recommended because seating is limited. There 
will be no onsite registration.
    Register online for the training course at the registration/
information Web site at https://www.trialstransformation.org/fda-clinical-investigator-training-course or by FAX to 919-660-1769. An e-
mail will be sent confirming your registration.
    Attendees are responsible for their own accommodations. A block of 
rooms has been reserved under ``FDA Clinical Investigator Course'' at 
the National Labor College at a reduced conference rate. Reservations 
can be made at https://www.supportnlc.org/Room_Reservations.html or by 
calling 301-431-6400. FDA has verified the Web site address, but is not 
responsible for subsequent changes to the Web site after this document 
publishes in the Federal Register.
    Registration materials, payment procedures, accommodation 
information, and a detailed description of the course can be found at 
    If you need special accommodations due to a disability, please 
contact Leonard Sacks at least 7 days in advance. Persons attending the 
course are advised that FDA is not responsible for providing access to 
electrical outlets.


I. Background

    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 course will cover a wide variety of key 
topics, including material on novel safety concerns, adverse event 
monitoring, compliance with the legal and ethical obligations of 
clinical research, and acceptable scientific and analytic standards in 
the design and conduct of clinical studies. The faculty will include a 
diverse representation of senior FDA staff, enabling FDA to communicate 
directly with clinical investigators on issues of greatest importance 
for successful clinical research.

II. Description of the Training Course

A. Purpose

    The training course is designed to provide clinical investigators 
with an overview of the following information:
     The essential toxicological, pharmacological, and 
manufacturing data to support investigational use in humans;
     Fundamental issues in the design and conduct of clinical 
     Statistical and analytic considerations in the 
interpretation of trial data;
     Appropriate safety evaluation during studies; and
     The ethical considerations and regulatory requirements for 
clinical trials.
    In addition, the course should do the following:
     Foster a cadre of clinical investigators with knowledge, 
experience, and commitment to investigational medicine;
     Promote communication between clinical investigators and 
     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.

B. Proposed Agenda

    The course will be conducted over 3 days and will comprise 
approximately 26 lectures, each lasting between 30 and 45 minutes. The 
course will be presented mainly by senior FDA staff, with guest 
lecturers presenting selected topics.
    On November 7, 2011, 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 8, 
2011, the course will include discussions of scientific, statistical, 
ethical, and regulatory aspects of clinical studies. On November 9, 
2011, participants will choose among three breakout sessions that 
explain how to put together an application to FDA for drugs, biologics, 
or devices.

C. Target Audience

    The course is targeted at health care professionals responsible 
for, or involved in, the conduct and/or design of clinical trials.

    Dated: July 25, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19149 Filed 7-28-11; 8:45 am]