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

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.


Notice of public workshop.


The Food and Drug Administration (FDA) Los Angeles District Office, in cosponsorship with the Society of Clinical Research Associates, Inc. (SoCRA) is announcing a public workshop entitled “FDA Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices.” The public workshop is intended 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 the FDA and clinical trial staff, investigators, and ivestigational review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents, and regulations relating to drugs, devices, and biologics, as well as inspections of clinical investigators, IRBs, and research sponsors.

Date and Time: The public workshop will be held on Wednesday and Thursday, May 5 and 6, 2010, 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, 949-729-1234.

Contact: Linda Hartley, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, 949-608-4413, FAX: 949-608-4417. Attendees are responsible for their own accommodations. To make reservations at the Hyatt Regency Newport Beach, contact the Hyatt Regency Newport Beach (see Location).

Registration: The SoCRA registration fees cover 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. Registration will close after the workshop is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration is as follows: FDA employee (fee waived), Government employee member ($450), Government employee nonmember ($525), non-Government employee SoCRA member ($575), non-Government employee non-SoCRA member ($650).

If you need special accommodations due to a disability, please contact Linda Hartley (see Contact) at least 10 days in advance of the public workshop.

Extended periods of question and answer and discussion have been included in the program schedule.

Registration instructions: To register, please submit a registration form with your name, affiliation, mailing address, phone, fax number, and e-mail, along with a check or money order payable to “SoCRA.” Mail to: SoCRA, 530 West Butler Ave., suite 109, Chalfont, PA 18914. To register via the Internet, go to​html/​FDA_​Conference.htm. (FDA has verified the Web site address, but we are not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

The registrar will also accept payment by major credit cards (VISA/MasterCard/AMEX only). For more information on the meeting, or for questions on registration, contact SoCRA at 800-762-7292 or 215-822-8644, FAX: 215-822-8633, or e-mail:

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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, institutional review board 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) Start Printed Page 14449keeping 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? What are the 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 workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) as an outreach activity by Government agencies to small businesses.

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Dated: March 19, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-6579 Filed 3-24-10; 8:45 am]