Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop, 17138 [2011-7192]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Page 17138]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7192]



[[Page 17138]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Food and Drug Administration Clinical Trial Requirements, 
Regulations, Compliance, and Good Clinical Practice; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) Denver District Office, in 
co-sponsorship with the Society of Clinical Research Associates 
(SoCRA), is announcing a public workshop. The public workshop on FDA's 
clinical trial requirements is designed to aid the clinical research 
professional's understanding of the mission, responsibilities, and 
authority of FDA and to facilitate interaction with FDA 
representatives. The program will focus on the relationships among FDA 
and clinical trial staff, investigators, and institutional review 
boards (IRBs). Individual FDA representatives will discuss the informed 
consent process and informed consent documents; regulations relating to 
drugs, devices, and biologics; as well as inspections of clinical 
investigators, IRBs, and research sponsors.
    Date and Time: The public workshop will be held on May 4 and 5, 
2011, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at The Curtis Hotel, 
1405 Curtis St., Denver, CO 80202, 1-303-571-0300.
    Attendees are responsible for their own accommodations. Please 
mention SoCRA to receive the hotel room rate of $119 plus applicable 
taxes (available until the SoCRA room block is filled).
    Contact: David Arvelo, Office of Regulatory Affairs, Food and Drug 
Administration, 4040 N. Central Expressway, suite 900, Dallas, Texas 
75204, 214-253-4952, FAX 214-253-4970, e-mail david.arvelo@fda.hhs.gov; 
or
    Society of Clinical Research Associates (SoCRA), 530 West Butler 
Ave., suite 109, Chalfont, PA 18914, 800-762-7292, FAX: 215-822-8633, 
e-mail: SoCRAmail@aol.com, Web site: https://www.SoCRA.org.
    Registration: The registration fee covers the cost of actual 
expenses, including refreshments, lunch, materials, and speaker 
expenses. Seats are limited; please submit your registration as soon as 
possible. Workshop space will be filled in order of receipt of 
registration. Those accepted into the public workshop will receive 
confirmation. The cost of registration follows:

                          Cost of Registration
------------------------------------------------------------------------
 
------------------------------------------------------------------------
SoCRA member..............................  $575.00
SoCRA nonmember (includes membership).....  $650.00
Federal Government SoCRA member...........  $450.00
Federal Government SoCRA nonmember........  $525.00
FDA Employee..............................  Fee Waived
------------------------------------------------------------------------

    If you need special accommodations due to a disability, please 
contact SoCRA (see Contact) at least 21 days in advance.
    Extended periods of question and answer and discussion have been 
included in the program schedule. SoCRA designates this educational 
activity for a maximum of 13.3 Continuing Education (CE) Credits for 
SoCRA CE and Nurse CNE. SoCRA designates this educational activity for 
a maximum of 13.3 American Medical Association Physician's Recognition 
Award Category 1 Credit(s)\TM\. Physicians should claim credit 
commensurate with the extent of their participation. SoCRA is 
accredited by the Accreditation Council for Continuing Medical 
Education to provide continuing medical education for physicians. SoCRA 
is an approved provider of continuing nursing education by the 
Pennsylvania State Nurses Association (PSNA), an accredited approver by 
the American Nurses Credentialing Center's Commission on Accreditation 
(ANCC). ANCC/PSNA Provider Reference Number: 205-3-A-09.
    Registration instructions: To register, please submit a 
registration form with your name, affiliation, mailing address, 
telephone, fax number, and email, along with a check or money order 
payable to ``SoCRA.'' Mail to: SoCRA (see Contact for address). To 
register on the Internet, go to https://www.socra.org/html/FDA_Conference.htm. (FDA has verified the Web site addresses throughout 
this document, but we are not responsible for any subsequent changes to 
the Web site after this document publishes in the Federal Register.)
    Payment by major credit card is accepted (Visa/MasterCard/AMEX 
only). For more information on the meeting registration, or for 
questions on the public workshop, contact SoCRA (see Contact).

SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the 
Department of Health and Human Services' and FDA's important mission to 
protect the public health. The public workshop will provide those 
engaged in FDA-regulated (human) clinical trials with information on a 
number of topics concerning FDA requirements related to informed 
consent, clinical investigation requirements, IRB inspections, 
electronic record requirements, and investigator initiated research. 
Topics for discussion include the following: (1) What FDA Expects in a 
Pharmaceutical Clinical Trial; (2) Adverse Event Reporting--Science, 
Regulation, Error, and Safety; (3) Part 11 Compliance--Electronic 
Signatures; (4) Informed Consent Regulations; (5) IRB Regulations and 
FDA Inspections; (6) Keeping Informed and Working Together; (7) FDA 
Conduct of Clinical Investigator Inspections; (8) Meetings With FDA: 
Why, When, and How; (9) Investigator Initiated Research; (10) Medical 
Device Aspects of Clinical Research; (11) Working With FDA's Center for 
Biologics Evaluation and Research; (12) The Inspection Is Over--What 
Happens Next? Possible FDA Compliance Actions; (13) Ethical Issues in 
Subject Enrollment; (14) Medical Device Aspects of Clinical Research; 
and (15) Are We There Yet? An Overview of the FDA Good Clinical 
Practice Program.
    FDA has made education of the drug and device manufacturing 
community a high priority to help ensure the quality of FDA-regulated 
drugs and devices. The public workshop helps to achieve objectives set 
forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 
393) which includes working closely with stakeholders and maximizing 
the availability and clarity of information to stakeholders and the 
public. The public workshop also is consistent with the Small Business 
Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) as 
outreach activities by Government Agencies to small businesses.

    Dated: March 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-7192 Filed 3-25-11; 8:45 am]
BILLING CODE 4160-01-P