[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Pages 3829-3830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01300]



Food and Drug Administration

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

Society of Clinical Research Associates--Food and Drug 
Administration: 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) is announcing an 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

[[Page 3830]]

clinical trial staff, investigators, and institutional review boards 
(IRBs). Individual FDA representatives will discuss the informed 
consent process including the informed consent documents, regulations 
relating to drugs, devices, and biologics, as well as inspections of 
clinical investigators, of IRBs, and of research sponsors.
    Date and Time: The public workshop will be held on March 12 and 13, 
2014, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Hyatt Regency 
Newport Beach Hotel, 1107 Jamboree Rd., Newport Beach, CA 92660, 949-
729-6061. Attendees are responsible for their own accommodations. 
Please mention SoCRA to receive the hotel room rate of $152.00 plus 
applicable taxes (available until February 18, 2014, or until the SoCRA 
room block is filled).
    Contact: Jane Kreis, Food and Drug Administration, 1301 Clay St., 
Suite 1180N, Oakland, CA 94612, 510-287-2708, FAX: 510-287-2739, 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: 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 workshop will receive confirmation. The cost of 
registration is as follows:

SoCRA member..............................  $575
SoCRA nonmember (includes membership).....  $650
Federal Government SoCRA member...........  $450
Federal Government SoCRA nonmember........  $525
FDA Employee..............................  Fee Waived

    If you need special accommodations due to a disability, please 
contact SoCRA, 800-762-7292 or 215-822-8644, FAX: 215-822-8633, or 
email: [email protected] 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 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, 
telephone, fax number, and email, along with a check or money order 
payable to ``SoCRA''. Mail to: Society of Clinical Research Associates 
(SoCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914. To 
register via the Internet, go to: http://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 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, 800-762-7292 or 215-
822-8644, FAX: 215-822-8633, or email: [email protected].

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) 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 safety and effectiveness 
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: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01300 Filed 1-22-14; 8:45 am]