Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA), Baltimore 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 the 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; regulation, relating to drugs, devices, and biologics; as well as inspections of clinical investigators, of IRB, and research sponsors.
If you need special accommodations due to a disability, please contact SoCRA or Cynthia Harris (see
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 nurse education (CNE). SoCRA designates this educational activity for a maximum of 13.3 American Medical Association Physician's Recognition Award Category 1 Credit(s)
Payment by major credit card is accepted (Visa/MasterCard/AMEX only). For more information on the meeting registration, or for questions on the public workshop, contact SoCRA (see
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 to informed consent, clinical investigation requirements, IRB inspections, electronic record requirements, and investigator initiated research. Topics for discussion include the following: (1) Are We There Yet?; (2) What FDA Expects in a Pharmaceutical Clinical Trial; (3) Medical Device Aspects of Clinical Research; (4) Adverse Event Reporting—Science, Regulation, Error, and Safety; (5) Working With FDA's Center for Biologics Evaluation and Research; (6) Ethical Issues in Subject Enrollment; (7) Keeping Informed and Working Together; (8) FDA Conduct of Clinical Investigator Inspections; (9) Investigator Initiated Research; (10) Meetings with FDA—Why, When, and How; (11) Part 11 Compliance—Electronic Signatures; (12) IRB Regulations and FDA Inspections; (13) Informed Consent Regulations; and (14) 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 (Pub. L. 104–121) as outreach activities by Government Agencies to small businesses.