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

Federal Register: Volume 76, Number 244 (Tuesday, December 20, 2011)
                  Pages 78933-78934

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

    The Food and Drug Administration (FDA), Los Angeles 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; 
regulations 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 March 7 and 8, 
2012, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Hyatt Regency 
Newport Beach, 1107 Jamboree Rd., Newport Beach, CA 92660, 1 (949) 729-
1234.
    Attendees are responsible for their own accommodations. Please 
mention SoCRA to receive the hotel room rate of $145.00 plus applicable 
taxes (available until February 14, 2012, or until the SoCRA room block 
is filled).
    Contact: Linda Hartley, Office of Regulatory Affairs, Food and Drug 
Administration, 19701 Fairchild, Irvine, CA 92612, (949) 608-4413, FAX: 
(949) 608-4417; or Society of Clinical Research Associates (SoCRA), 530 
West Butler Ave., Suite 109, Chalfont, PA 18914, 1 (800) 762-7292 or 
(215) 822-8644; FAX: (215) 822-8633, email SoCRAmail@aol.com, 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 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..................    450.00
Federal Government SoCRA nonmember...............    525.00
FDA Employee.....................................       [*]
------------------------------------------------------------------------
* Fee Waived.

    If you need special accommodations due to a disability, please 
contact SoCRA or Linda Hartley (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 
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 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).

[[Page 78934]]

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 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 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; and (12) 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 (Public Law 104-121) as 
outreach activities by Government Agencies to small businesses.

    Dated: December 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32435 Filed 12-19-11; 8:45 am]
BILLING CODE 4160-01-P