[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Pages 49448-49449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19851]



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), Baltimore District Office, 
in cosponsorship 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 the 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 (IRB). Individual FDA representatives will discuss the informed 
consent process and informed consent documents; regulation, relating to 
drugs, devices, and biologics; as well as inspections of clinical 
investigators, of IRB, and research sponsors.
    Date and Time: The public workshop will be held on November 14 and 
15, 2012, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Radisson Plaza 
Lord Baltimore Hotel, 20 West Baltimore St., Baltimore, MD 21201, 410-
539-8400. Attendees are responsible for their own accommodations. 
Please mention SoCRA to receive the hotel room rate of $129.00 plus 
applicable taxes (available until October 13, 2012, or until the SoCRA 
room block is filled).
    Contact: Cynthia A. Harris, Food and Drug Administration, 6000 
Metro Dr., Suite 101, Baltimore, MD 21215, 410-779-5133, FAX: 410-779-
5705; or Society of Clinical Research Associates (SoCRA), 530 West 
Butler Ave., Suite 109, Chalfont, PA 18914, 800-762-7292 or 215-822-
8644; Fax: 215-822-8633, email: [email protected], Web site: http://www.socra.org.
    Registration: The registration fee will cover 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 the registration is as follows:

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

    If you need special accommodations due to a disability, please 
contact SoCRA or Cynthia Harris (see Contact) at least 21 days in 
    Extended periods of question and answer and discussion have been 
included in the program schedule. SoCRA designates this education 
activity for a maximum of 13.3 Continuing Education (CE) Credits for 
SoCRA CE and continuing nurse education (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 only the credit commensurate with the extent of 
their participation. SoCRA is

[[Page 49449]]

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: 205-3-1-09.
    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 via the Internet, go to http://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 sites after this document is published in the Federal 
    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) Are We There Yet?; (2) 
What FDA Expects in a Pharmaceutical Clinical Trial; (3) Medical Device 
Aspects of Clinical Research; (4) Adverse Event Reporting--Science, 
Regulation, Error, and Safety; (5) Working With FDA's Center for 
Biologics Evaluation and Research; (6) Ethical Issues in Subject 
Enrollment; (7) Keeping Informed and Working Together; (8) FDA Conduct 
of Clinical Investigator Inspections; (9) Investigator Initiated 
Research; (10) Meetings with FDA--Why, When, and How; (11) Part 11 
Compliance--Electronic Signatures; (12) IRB Regulations and FDA 
Inspections; (13) Informed Consent Regulations; and (14) The Inspection 
Is Over--What Happens Next? Possible FDA Compliance Actions.
    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. 2012-19851 Filed 8-15-12; 8:45 am]