Managing Clinical Trials During the COVID-19 Pandemic
The FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. The FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19. This web seminar will discuss the recent FDA guidance for Industry, Investigators and Institutional Review Boards, Conduct of Clinical Trials of Medicinal Products during the COVID-19 Pandemic issued March 2020, which outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity.
- Review the latest FDA Guidance on COVID-19 and Clinical Trials
- Discuss FDA and IRB recommendations for handling study variances and safety management due to necessary deviations from approved protocols
- Evaluate elements of risk management applications in clinical trials as applied to emerging changes in our society
Who Should Attend
- Clinical Operations Personnel at Sponsors, CROs and Sites
- Clinical Research Associates
- Medical Affairs Specialists and Leaders
- Project Managers/Team Leaders
- Data Managers
- New Clinical Staff or other Project Team Leaders who will be managing clinical trial projects
- Physician Investigators and Clinical Research Coordinators
- Regulatory Affairs Professionals
- Quality Assurance/Control (QA/QC) Professionals
Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.
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.
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#: 0778-0000-20-088-L04-P. Released: 4/20.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.