Document ID: FDA-2014-N-0001-0089
Agency: fda
Document Type: Notice
Title: Society of Clinical Research Associates—Food and Drug
Administration: Food and Drug Administration Clinical Trial
Requirements, Regulations, Compliance, and Good Clinical
Practice; Public Workshop
Posted Date: 2014-10-14T04:00Z

[Federal Register Volume 79, Number 198 (Tuesday, October 14, 2014)]
[Notices]
[Pages 61645-61646]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24307]

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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: 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 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 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 5 and 
6, 2014, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Wyndham Lake 
Buena Vista Hotel, 1850 Hotel Plaza Blvd., Lake Buena Vista, FL 32830, 
407-828-4444.
    Attendees are responsible for their own accommodations. Please 
mention SoCRA to receive the hotel room rate of $95.00 plus applicable 
taxes (available until October 6, 2014, or until the SoCRA room block 
is filled).
    Contact: C. Stewart Watson, Food and Drug Administration, 555 
Winderley Pl., Suite 200, Maitland, FL 32751, 407-475-4756, FAX: 407-
475-4768, 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, 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 
the registration is as follows: SoCRA member--$575; SoCRA nonmember 
(includes membership)--$650; Federal Government 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 (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 nursing 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 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. (FDA has verified the Web site addresses throughout 
this document, but we are not responsible for any subsequent changes to 
the Web

[[Page 61646]]

sites after this document is published 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 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 informed consent, 
clinical investigation requirements, institutional review board 
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; (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 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: October 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24307 Filed 10-10-14; 8:45 am]
BILLING CODE 4164-01-P