Since its inception in 2000, the clinical trials registry has served as a source of information for the general public, academia, and industry. In 2007, the U.S. Congress passed FDAAA, which required additional trial registration information, more types of trials to be registered, and the submission of summary results for applicable clinical trials. The following year, sponsors and Principal Investigators would begin submitting the results of clinical studies on ClinicalTrials.gov. Although submission of Adverse Event information was optional when the results database was released, it became required in September 2009.
Despite these requirements, recent studies indicate that not all required information is submitted. In late 2012, the U.S. DHHS transferred authority to the FDA to oversee ClinicalTrials.gov and seek out those who do not file, or file misleading or false data.
- Discuss the purpose and procedures for registration and the requirements for submission of results
- Explore who is responsible for registration and reporting, who benefits and how, and which entities require compliance
- Explain an “applicable clinical trial” and exceptions to registration and reporting
- Examine timelines for reporting and extensions and penalties for noncompliance
- Review procedures for editing and updating submissions
- Professionals from Academia whose institutions or Investigators hold INDs or IDEs, or whose institutions support clinical research with Site Management Organizations (SMOs)
- Clinical Quality Assurance Auditors and Compliance Professionals
- Clinical Research Associates
- Regulatory Affairs Professionals
Elizabeth Ronk Nelson, M.P.H.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-13-057-L01-P. Released: 8/13.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.