[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Pages 49449-49450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19852]



Food and Drug Administration

[Docket No. FDA-2012-N-0001]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.


    The Food and Drug Administration (FDA), Office of Regulatory 
Affairs (ORA), Dallas 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 March 6 and 7, 
2013, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Sheraton Dallas 
Hotel, 400 North Olive St., Dallas, TX 75201, 214-922-8000.
    Attendees are responsible for their own accommodations. Please 
mention SoCRA to receive the hotel room rate of $145 plus applicable 
taxes (available until February 3, 2013, or until the SoCRA room block 
is filled).
    Contact: David Arvelo, Office of Regulatory Affairs, Food and Drug 
Administration, Southwest Regional Office, 4040 North Central 
Expressway, Suite 900, Dallas, TX 75204, 214-253-4952, Fax: 214-253-
4970, email: [email protected] or SoCRA, 530 West Butler Ave., 
Suite 109, Chalfont, PA 18914, 800-762-7292, FAX: 215-822-8633, email: 
[email protected], Web site: http://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 workshop will receive 
confirmation. The cost of registration is as follows:

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 continuing nursing education (CNE). SoCRA designates 
this educational activity for a maximum of 13.3 American Medical 
Association Physicians 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 CNE 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, phone, 
fax number, and email, along

[[Page 49450]]

with a check or money order payable to ``SoCRA''. Mail to: SoCRA (see 
Contact for address). To register via the Internet, go to http://www.socra.org/html/FDA_Conference.htm. (FDA has verified the Web site 
address, but we are not responsible for any subsequent changes to the 
Web site after this document is published 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 workshop, contact SoCRA (see Contact).

SUPPLEMENTARY INFORMATION: The public conference helps fulfill the 
Department of Health and Human Services' and FDA's important mission to 
protect the public health. The 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: August 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19852 Filed 8-15-12; 8:45 am]