[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Pages 51040-51041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20858]



Food and Drug Administration

[Docket No. FDA-2011-N-0002]

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) Philadelphia 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 (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, IRB, and research sponsors.
    Date and Time: The public workshop will be held on November 16 and 
17, 2011, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Sheraton 
Philadelphia City Center Hotel, 201 North 17th St., Philadelphia, PA 
19103, 1-215-448-2000.
    Attendees are responsible for their own accommodations. Please 
mention SoCRA to receive the hotel room rate of $159 plus applicable 
taxes (available until November 1, 2011, or until the SoCRA room block 
is filled).
    Contact: Anne Johnson, Food and Drug Administration, Philadelphia 
District, 900 U.S. Customhouse, Second & Chestnut Streets, 
Philadelphia, PA 19106, 215-597-4390, FAX: 215-597-4660, e-mail: 
[email protected]; 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, e-mail: [email protected], 
Web site: http://www.SoCRA.org. (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.)
    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:

                          Cost of Registration
SoCRA member.............................  ($575.00)
SoCRA nonmember (includes membership)....  ($650.00)
Federal Government member................  ($450.00)
Federal Government nonmember.............  ($525.00)
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 educational 
activity for a maximum of 13.3 Continuing Education Credits for SoCRA 
CE and Nurse CNE. SOCRA designates this live activity for a maximum of 
13.3 AMA PRA Category 1 Credit(s) TM. Physicians should 
claim only the credit commensurate with the extent of their 
participation. CME 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 continuing nursing education 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 e-mail, 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. 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 

[[Page 51041]]

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 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); 
(15) Are We There Yet? An Overview of the FDA GCP 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 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20858 Filed 8-16-11; 8:45 am]