[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Pages 8886-8887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3553]



Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Food and Drug Administration Clinical Trial Requirements, 
Regulations, Compliance, and Good Clinical Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.


SUMMARY: The Food and Drug Administration (FDA) Detroit 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 May 9 and 10, 
2012, from 8 a.m. to 5 p.m.

[[Page 8887]]

    Location: The public workshop will be held at the Marriott Ann 
Arbor Ypsilanti at Eagle Crest, 1275 S. Huron St., Ypsilanti, MI 48197, 
    Contact: 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: [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.); or 
Nancy Bellamy, Food and Drug Administration, Detroit District Office, 
300 River Pl., Suite 5900, Detroit, MI 48207, 313-393-8143, Fax: 313-
393-8139, email: [email protected].
    Accommodations: Attendees are responsible for their own 
accommodations. Please mention SoCRA to receive the hotel room rate of 
$119 plus applicable taxes (available until April 17, 2012 or until the 
SoCRA room block is filled).

                          Cost of Registration
SoCRA member...............................................         $575
SoCRA nonmember (includes membership)......................          650
Federal Government member..................................          450
Federal Government nonmember...............................          525
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 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. 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 

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: February 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3553 Filed 2-14-12; 8:45 am]