81 FR 7802 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 30 (February 16, 2016)

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Educational Conference Co- Sponsored With the Society of Clinical Research Associates (SOCRA).'' 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, clinical trial staff, investigators, and institutional review boards (IRBs). 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 IRBs, and of research sponsors.

[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7802-7803]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Food and Drug Administration Clinical Trial Requirements, 
Regulations, Compliance, and Good Clinical Practices; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Educational Conference Co-
Sponsored With the Society of Clinical Research Associates (SOCRA).'' 
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, clinical trial staff, investigators, and institutional 
review boards (IRBs). 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 IRBs, and of research sponsors.

DATES: The public workshop will be held on March 9 and 10, 2016, from 8 
a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the Holiday Inn San 
Diego Bayside, 4875 North Harbor Dr., San Diego, CA 92106, 619-224-
3621.

FOR FURTHER INFORMATION 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, 
telephone: 800-762-7292 or 215-822-8644, FAX: 215-822-8633, 
[email protected], Web site: 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.)

SUPPLEMENTARY INFORMATION: 

I. Background

    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.
    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 workshop helps to achieve objectives set forth 
in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393), 
which include 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.

II. Topics for Discussion at the Public Workshop

    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; (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.
    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, Federal

[[Page 7803]]

Government nonmember--$525, and FDA Employee--(free) Fee Waived.
    Attendees are responsible for their own accommodations. Please 
mention SOCRA to receive the hotel room rate of $142 plus applicable 
taxes (available until the SOCRA room block is filled).
    If you need special accommodations due to a disability, please 
contact SOCRA (see FOR FURTHER INFORMATION 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 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: Society of 
Clinical Research Associates is accredited as a provider of continuing 
nursing education by the American Nurses Credentialing Center's 
Commission on Accreditation.
    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 FOR FURTHER INFORMATION 
CONTACT). To register via the Internet, go to http://www.socra.org/html/FDAConference.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 FOR 
FURTHER INFORMATION CONTACT).

    Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02965 Filed 2-12-16; 8:45 am]
 BILLING CODE 4164-01-P