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Presenters: Kristin Anderberg, RN, BSN & Doran Triggs, BS
The mission of the Stanford Center for Clinical Research (SCCR) includes offering educational resources, training, and support for investigators and research staff. We have invited SCCR’s Quality and Compliance Manager, Kristin Anderberg, RN, BSN, and her team member Doran Triggs, BS, to provide you an overview of the TMF and importance of maintaining a TMF.
At the conclusion of this class, you will be able to:
- Understand the definition of TMF and ISF
- Recognize the requirements
- Learn how to manage the TMF
- Identify recommended contents for TMF
- Understand Inspection Readiness
- Outline common errors
Attendance is open to all research staff
About the Instructors:
Kristin Anderberg, RN, BSN received her BSN from Emory University in Atlanta. Following graduation she worked in the pediatric cardiac ICU. She has over 30 years of research experience working for AROs and industry. Her knowledge extends to clinical trial management for global studies, GCP, compliance audits, regulatory agency inspections, clinical events classification, quality management of clinical trials, policy and procedure development. She currently works at SCCR as Quality and Compliance Manager, and her passion in research is quality, clinical events classification, and endpoint adjudication.
Doran Triggs, BS, is a Clinical Research Coordinator II, within SCCR’s Quality and Compliance team. Doran has been in the clinical research field for over 4 years. She first joined SCCR in 2018 as a CRC working on Vascular Surgery and Women’s Heart Health trials. Within her 4 years Doran focused her training on regulatory compliance and study data monitoring. Since 2021 she has transitioned to a role on SCCR’s Quality and Compliance team where she provides support to study teams within SCCR. Most recently she helped develop and manage SCCR’s monitoring program as well as monitor multiple trials within SCCR and other departments across the SOM.
Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 1.5 contact hour(s).
To receive your certificate with BRN credit, you are required to complete an evaluation at the conclusion of this class.
BRN Cancellation Policy: If you wish to cancel your registration, please contact Susan Saba at firstname.lastname@example.org.