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

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The Food and Drug Administration (FDA) New Jersey District Office, in cosponsorship 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 (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, IRBs, and research sponsors.

Date and Time: The public workshop will be held on November 4 and 5, 2010, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Hyatt Regency Jersey City, Two Exchange Pl., Jersey City, NJ 07302, 1-800-233-1234. (The hotel is connected to the PATH Train to New York City). Attendees are responsible for their own accommodations. Please mention SoCRA to receive the hotel room rate of $169 plus applicable taxes (available until October 20, 2010, or until the SoCRA room block is filled).

Contact: Joan Lytle, Food and Drug Administration, 120 North Central Dr., North Brunswick, NJ 08902, 732-940-8946 ext. 33, FAX: 732-940-8936, or Society of Clinical Research Associates (SoCRA), 530 West Butler Ave., suite 109, Chalfont, PA 18914, 800-762-7292, FAX: 215-822-8633, email:, Web site:

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 or receipt of registration. Those accepted into the workshop will receive confirmation. The cost of registration is as follows: SoCRA member ($575.00), SoCRA nonmember (includes membership) ($650.00), FDA/Federal Government member ($450.00), FDA/Federal Government nonmember ($525.00).

If you need special accommodations due to a disability, please contact SoCRA (see Contact) at least 10 days in advance.

Extended periods of question and answer and discussion have been included in the program schedule. This program offers 13.3 hours of continuing medical education (CME) and continuing nursing education (CNE) credit. 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, phone, 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​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.)

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 Contacts).

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The public conference 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.

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 (Public Law 104-121) as outreach activities by Government agencies to small businesses.

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Dated: August 17, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-20834 Filed 8-20-10; 8:45 am]