Document ID: FDA-2014-N-0001-0020
Agency: fda
Document Type: Notice
Title: Society of Clinical Research Associates—Food and Drug
Administration Clinical Trial Requirements, Regulations,
Compliance, and Good Clinical Practice; Public Workshop
Posted Date: 2014-02-19T05:00Z

[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Notices]
[Page 9471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03583]

[[Page 9471]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Society of Clinical Research Associates--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.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Educational Conference Co-Sponsored With the 
Society of Clinical Research Associates (SoCRA).'' The public workshop 
regarding 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 21 and 22, 
2014, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Sheraton 
Indianapolis at Keystone Crossing, 8787 Keystone Crossing, 
Indianapolis, IN 46240, 317-846-2700.
    Attendees are responsible for their own accommodations. Please 
mention SoCRA to receive the hotel room rate of $109.00 plus applicable 
taxes (available until April 20, 2014, or until the SoCRA room block is 
filled).
    Contact: Myra K. Casey, Food and Drug Administration, 101 West Ohio 
St., Suite 500, Indianapolis, IN 46204, 317-226-6500, ext. 104; 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: SoCRAmail@aol.com.
    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 workshop will receive confirmation. The cost of 
the registration is as follows: SoCRA member, $575.00; SoCRA nonmember 
(includes membership), $650.00; Federal Government member, $450.00; 
Federal Government nonmember, $525.00; and FDA employee, free (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 education 
activity for a maximum of 13.3 Continuing Education (CE) Credits for 
SoCRA CE and continuing nurse education (CNE). SoCRA designates this 
live activity for a maximum of 13.3 American Medical Association 
Physicians Recognition Award Category 1 Credit(s)TM. 
Physicians should claim only the credit commensurate with the extent of 
their participation. Continuing Medical Education for physicians: SoCRA 
is accredited by the Accreditation Council for Continuing Medical 
Education to provide continuing medical education for physicians. CNE 
for nurses: SoCRA is accredited as a provider of CNE by the American 
Nurses Credentialing Center's Commission on Accreditation.
    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://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 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 on related informed 
consent, clinical investigation requirements, IRB inspections, 
electronic record requirements, and investigator initiated research. 
Topics for discussion include the following: (1) The Role of the FDA 
District Office Relative to the Bioresearch Monitoring Program (BIMO); 
(2) Modernizing FDA's Clinical Trials/BIMO Programs; (3) What FDA 
Expects in a Pharmaceutical Clinical Trial; (4) Medical Device Aspects 
of Clinical Research; (5) Adverse Event Reporting--Science, Regulation, 
Error, and Safety; (6) Working with FDA's Center for Biologics 
Evaluation and Research; (7) Ethical Issues in Subject Enrollment; (8) 
Keeping Informed and Working Together; (9) FDA Conduct of Clinical 
Investigator Inspections; (10) Investigator Initiated Research; (11) 
Meetings with FDA: Why, When and How; (12) Part 11 Compliance--
Electronic Signatures; (13) IRB Regulations and FDA Inspections; (14) 
Informed Consent Regulations; (15) The Inspection is Over--What Happens 
Next? Possible FDA Compliance Actions; and (16) Question and Answer 
Session/Panel Discussion.
    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: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03583 Filed 2-18-14; 8:45 am]
BILLING CODE 4160-01-P