With
the need to “shelter in place” and reduced social interactions due to the
COVID-19 pandemic, it is more important than ever to look at ways to manage the
conduct of clinical trials remotely, in real-time. Sites have had to modify
strategies to manage patients in clinical trials and sponsors/CROs need to
adapt quickly to meet obligations to the FDA and the general public to ensure
trials are conducted under GCP. With sponsors/CROs focusing on expanding
approaches to monitoring remotely, this web seminar will evaluate process and
documentation, explore techniques for identifying issues at sites remotely, and
examine the regulatory expectations for managing compliance. Better utilization
of remote monitoring is critical to ensure sites are compliant and the data is
accurate and consistent. Strategies for remote monitoring will be addressed,
including the review of data trends, remote study management and communication,
and “red flags” that may indicate issues on site.
- Evaluate development of monitoring plans through
protocol analysis for remote risk management
- Discuss tools and risk evaluation
approaches for remote monitoring
- Explain techniques for practical
corrective and preventive actions to ensure clear communication and
resolution and documentation of issues
- Clinical Research Associate Managers
- Clinical Research Associates
- Project Managers
- Clinical Trial Managers
- Study Coordinators
Nikki
Christison, B.S., C.C.R.A., T.I.A.C.R.
Click here for complete trainer
biographies
$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.
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#: 0778-0000-20-097-L04-P. Released: 4/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.