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Presenter: Kiera Davis, RN, BSN
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 the Clinical Associate Director of Education and Training, Kiera Davis, RN, BSN, to present you with the history of human subjects research protection.
At the conclusion of this class, you will be able to:
- Understand the definition of human subjects research and exemptions
- Differentiate between human subjects and non-human subjects research
- Review the NIH decision tree for clinical trial
- Review the historical background of HSR and the corresponding principles, regulations and GCP
- Describe the most common forms on noncompliance/violations
Attendance is open to all research staff
About the Instructor:
Kiera Davis, RN, BSN joined Stanford University in 2015 and is the Clinical Associate Director of Education and Training in the Stanford Center for Clinical Research. She has worked in clinical research for 10 years at Stanford University and at the Duke Clinical Research Institute. Kiera obtained a BA in History from Boston University in 2006 followed by a BS in Nursing from Duke University. She worked as a Clinical Nurse II in the pediatric cardiac intensive care unit at Duke Hospital followed by two years as a travel nurse, working at Children’s Hospital of Los Angeles, Colorado Children’s in Denver, CO, Stanford Children’s Hospital, and Seattle Children’s Hospital. She is currently working towards a Master’s of Science in Clinical Research from Campbell University with projected graduation in Spring 2022.
BRN OPTIONAL
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 ssaba@stanford.edu.
Click HERE to Register!
Presenter: Kristin Anderberg, RN, BSN
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, to present you with quality incident reporting, and how it does differ from CAPA.
At the conclusion of this class, you will be able to:
- Understand Quality Incidents
- Recognize why quality incident reporting is important
- Identify how quality incident differ from CAPA
- Apply your learning to research
Attendance is open to all research staff
About the Instructor:
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.
BRN OPTIONAL
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 ssaba@stanford.edu.
Click HERE to Register!
Presenters: Allison Gerger and Dianne Ferris
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 Allison Gerger, and, Dianne Ferris, from Stanford Research Compliance Office (RCO) to present you with the definitions that the Institutional Review Board (IRB) uses to make human subjects research determinations and review types of projects that do not meet these definitions. This course will include real-world examples to test participants’ knowledge, as well as provide resources for use in the future.
At the conclusion of this class, you will be able to:
- Better understand the definitions the IRB uses to make these determinations
- Recognize examples of common projects that do NOT meet the definitions of human subject research
- Submit to the Stanford IRB for HSR determination in e-Protocol
- Locate human subjects research-related guidance on our website
- Determine who to contact should you have any questions in the future
Attendance is open to all research staff
About the Instructors:
Dianne Ferris, is a Sr. Quality and Compliance Manager within the Continuous Quality Improvement (CQI) division of the RCO. She joined Stanford in this role in 2018 and conducts various quality and compliance reviews within the IRB as well as external consent form audits and compliance reviews. Dianne earned a Master’s Degree in Pharmacology and Toxicology from Dartmouth Medical School with a focus on carcinogenesis and growth factor signaling. After graduating, she worked for Dartmouth’s IRB Office for 6 years as a Senior IRB Analyst, and then moved to their Cancer Center as their Regulatory and Compliance Officer. Dianne has a special interest and expertise in writing consent forms and conducting effective consent discussions and has presented on this topic at various conferences around the country.
Allison Gerger, is the Program Development Lead for the Research Compliance Office (RCO). She leads the Continuous Quality Improvement (CQI) division, which is responsible for designing, overseeing, and implementing a program to evaluate, track, and monitor the effectiveness of the Stanford RCO to ensure the rights and welfare of research subjects and compliance with applicable laws. She earned her Bachelor of Science degree in Biology from Gannon University, Master of Public Health in Epidemiology from the University of Pittsburgh, and Registered Nurse licensure from the Community College of Allegheny County. Allison has over 15 years of combined experience in research, research administration, and research compliance.
BRN OPTIONAL
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 ssaba@stanford.edu.
Click HERE to Register!
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.
BRN OPTIONAL
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 ssaba@stanford.edu.