Monitoring Considerations for Clinical Trials Using eConsent
Sponsored by: CRF Health
- Clinical Trial
Date: 8 March
Time: 4PM London/11AM New York
Creating an Easier Consent Process that Saves Time, Reduces Costs, and Boosts Efficiency
Sponsors are responsible to ensure proper consenting of subjects at clinical research sites prior to study procedures happening. It is a challenge to perform this in a timely manner while also ensuring human subject protection and data integrity. (Inadequate consent is still in the top 5 health authority site inspection findings globally!) Even in the landscape of risk-based monitoring and reduced onsite visits, monitoring informed consent still requires primarily onsite visits by sponsor monitors. This has not been effective or efficient for the industry to reduce informed consent issues and manage risks.
During this webinar, informed consent experts with decades of hands-on monitoring experience discuss the challenges they’ve encountered and how to overcome them with the integration of eConsent. How can eConsent improve the efficiencies of monitoring informed consent and decrease the risk of consent issues at site to better support human subject protection and data integrity?
Electronic Informed Consent (eConsent) enables monitors to be more efficient, remotely review consent, track progress at sites, prioritize visits and more. But how does using an eConsent better support monitoring? How does eConsent integration impact the sponsor / CRO monitoring processes, monitoring plans, communication with sites, report writing, and other systems from qualification visits to close-out visits?
How can monitors and CRAs achieve all of this with eConsent? Register for our webinar, â€œMonitoring Considerations for Clinical Trials Using eConsent: Creating an Easier Consent Process that Saves Time, Reduces Costs, and Boosts Efficiency,â€ to learn more about how to optimize your informed consent process. We hope to see you there!
Sandra â€œSAMâ€ Sather, MS, BSN, CCRA, CCRC,
Regulatory and Quality, CRF Health
SAM has over 30 years of clinical experience, a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. She has served many roles in clinical research, including site study coordinator and manager, sponsor and CRO monitor, quality assurance auditor, risk manager, trainer, and performance management consultant. SAM has held clinical research industry certifications for over 15 years by the Association for Clinical Research Professionals (ACRP).
She is a current member of the ACRP Academy Board of Trustees, and Regulatory Affairs Committee (RAC). SAM is a frequent subject matter expert for GCP regulation and speaker at industry conferences. Sam has authored many competency-based curriculums for various clinical research stakeholders.
Elizabeth Weeks-Rowe, LVN, CCRA,
Clinical Research Consultant
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 18 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. She has developed course content and presented research topics for leading industry training and education organizations. She has created website content and newsletters for European and US based Clinical Research Organizations. She is a contributing writer for several leading industry publications, including a recurring clinical research column for â€œCenterwatch Monthly.â€
She has authored a white paper on best industry practices for co-monitoring assessments, and unblinded pharmacy monitoring/monitoring practice. She is the author of a clinical research novella entitled â€œClinical Research Trials and Triumphs; a heart warming novel following a nurse’s journey into clinical research.â€
She authored the 2016 updates to the well known clinical research industry guidebook, â€œCRAs Guide to Monitoring Clinical Researchâ€ by Centerwatch. For the last 6 years, she has worked in relationship development/study startup for a leading CRO, in a critical site selection and training role.
Deborah Rosenbaum, CCRA, CCRC, FACRP,
President, Sarrison Clinical Research
Deborah Rosenbaum is the President of Sarrison Clinical Research and has over 35 years of clinical experience. She is a certified CRC and CRA by ACRP, and is a Fellow of the organization. Ms. Rosenbaum has served on the ACRP Board of Directors, the Academy Board of Trustees, and was the 2014 Chair of the Academy.
She served as the Standard’s Officer for the ACRP Institute’s Educational Standards and Accreditation Committee and has volunteered on various ACRP committees. Ms. Rosenbaum is also the coauthor of a series of 3 books on clinical research entitled, â€œThe Practical Clinical Trial Series.â€ She has been a Subject Matter Expert (SME) for multiple programs, including CITI GCP modules. Ms. Rosenbaum participated in the development of the ACRP Certification Review (Preparation) courses for the FDA region for CRCs, CRAs, and investigators since 1995.
Finally, Ms. Rosenbaum became credentialed by the American Medical Writers Association in November 1996. Other training credentials she holds include: Certified Training Generalist, ACRP Credentialed Trainer, Certified Master Trainer, and Certified E-Learning Specialist.
Key Learning Objectives
- Recognize how eConsent included in a clinical trial impacts monitoring processes and documentation
- Learn how to enhance the monitoring process to save time, reduce costs, and boost efficiencies
- Discover how data integrity and human subject protection is improved with an eConsent solution
- Uncover what you should consider before your next clinical trial with eConsent
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