Clinical Trial Registration: Requirements, Record Maintenance and Reporting of Results

Course Description

The registration and summary results reporting of clinical trials has two main purposes: To inform potential subjects, and to increase transparency of conducted clinical trials and the likelihood that negative results of trials will be publicized. This web seminar will explore the requirements and challenges clinical teams and sponsoring organizations face in determining if a clinical trial is qualified and required to be registered, including determining the time frame for updates to be posted and the reporting of results.

Learning Objectives

• Discuss key factors to consider for the registration of clinical trials
• Review rules, policies and guidelines to identify operational processes and best practices to register clinical trials, provide updates in a timely manner and file final reports
• Review “Summary of HHS Final Rule and NIH Policy on Registration/Reporting in ClinicalTrials.gov” in NEJM (Nov. 2016)
• Provide overview of the registration process on ClinicalTrials.gov
• Discuss record maintenance and results reporting requirements

Who Should Attend

• Regulatory Affairs Professionals working in biotech, pharmaceutical products and medical device companies
• Medical Affairs Professionals
• Project Managers
• Clinical Research Associates involved in the planning, monitoring, and execution of clinical trials, and responsible for clinical trial reporting
• Grant Managers
• Principal Investigators

Instructor

Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

Click here for complete trainer biographies

Registration Fees

$735

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 +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com

Accreditation Information

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 issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-21-048-L04-P. Released: 9/21. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.