Sarah Fowler Dixon
Education specialist
Sarah Fowler-Dixon, PhD, CIP is an Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
Upcoming Webinar
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Recorded Webinar
Investigational Product Accountability Best Practices
"An FDA inspector once said that any individual should be able to perform drug reconciliation at an investigative site within 20 minutes." (2002 Applied Clinical Trials). Conducting a clinical trial with a drug or device that is not FDA approved or that is being used in an investigational manner can be daunting. A site must know the federal regulations, and have accountability practices. All this can be very daunting.
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Protocol Deviations: Documenting, Managing and Reporting
Deviations have often been misunderstood, misclassified and misreported. This webinar will help you to answer questions about deviations such as: What is a deviation? What’s the best way to manage deviations? Can they be avoided? What is their importance? Does deviations impact subject safety or data integrity? How can the research team anticipate, manage, and minimize the impact of protocol deviations?
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Falsifying Data in Clinical Trials: What to Report?
Falsifying data in clinical trials is also considered data fraud. When data fraud occurs there are most likely other unreported or undetected misconduct that occurred within a clinical trial. This leads to poor, unreplicable results. When results cannot be replicated, questions arise about why a trial was conducted and what types of risks or harms were the participants exposed to. Additionally, poor data collection eliminates the possibility of being able to prove or disprove the hypothesis leaving the research question unanswered and possibly leaving a valuable solution to a problem unused.
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Trial Master File (TMF): FDA Expectations from Sponsors and Sites
The recommended and required contents of the trial master file (TMF) continue to be a concern for clinical trial professionals. All companies and investigators conducting clinical trials in the pharmaceutical/biotech industry maintain documentation for each clinical trial. Each company has their own unique TMF structure as defined by their SOPs however many are not clear on the regulatory expectations. This course will provide participants with an understanding of the site and sponsor regulatory expectations when it comes to the TMF.
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The Sunshine Act: Reporting for Clinical Trials
The Sunshine Act exposes the physicians and sponsors to new reporting requirements which are unprecedented in their scope and detail noncompliance to which would lead to hefty fines. This webinar will summarize the new requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and investigators. Templates for reporting format, acceptable accounting practices, exemptions to reporting requirements and time-lines for compliance and enforcement will be discussed.
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Challenges for Data Collection in Clinical Trials for Low-Cost Wearable Health Monitors
Activity monitors, smart watches, patches are just some examples of wearable monitors. Health care is full of them, sleep monitors, EKGs, radiation exposure devices, and respirator devices to name a few. With more and more of these devices becoming common place, it's inevitable that researchers will want to mine this data. Collection and use of some of this data is already occurring as research participants are given the devices to wear and data collection goes into a research record. But, with the commonplace use of these devices for recreational purposes, it's safe to assume that a researcher at some point will ask to access and use data that was not originally generated for research purposes.
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Clinical Trial Monitoring - Documentation and Closure
Using Good Clinical Practice guidance and the federal regulations, this session will discuss documentation during a clinical trial. Documentation during a clinical trial includes case report forms, source documents and standard operating procedures. This session will also discuss considerations and procedures relevant to closing a study. Once a study is closed, some materials may not be accessible. What may/may not be accessed after study closure will be discussed.
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Trial Master File (TMF): FDA Expectations from Sponsors and Sites
This webinar will help participants learn what is required of a Trial Master File for a clinical trial, and will acquire a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor. Also, Attendees will learn which documents are essential, and which ones are not necessary in the event of an FDA audit.
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The Sunshine Act: Reporting for Clinical Trials
The Sunshine Act or Open Payments Program requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act.
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Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance
The FDA guidance has rapidly increased the use of electronic data capture. Pharma and Investigators seek to minimize the burden of documentation in the conduct of clinical trials. Pursuance of that goal without focus on inspectional compliance can incur a failed regulatory inspection. FDA regs 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance.
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FDA Electronic Data Capture Guidance - What is the impact on Investigator Site Inspectional Source Record Requirements?
The FDA guidance has rapidly increased the use of electronic data capture. Pharma and Investigators seek to minimize the burden of documentation in the conduct of clinical trials. Pursuance of that goal without focus on inspectional compliance can incur a failed regulatory inspection.
Recorded Session Get life time access for one participant with download option!

Differences between Device and Drug Clinical Research - A Jeopardy Learning Game
This webinar will discuss the differences between device and drug clinical research and the current regulations governing the use of drugs and devices in a clinical study.
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IRBs and the changing landscape
This clinical research training will explain the Institutional Review Board (IRB) models. It will discuss the regulatory framework for IRB review including 21 CFR 50, 56 and 45 CFR 46.
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What are Serious Adverse Events and how do I handle these?
Serious adverse events along with adverse events, anticipated events, unanticipated events and unanticipated problems are often confused and misunderstood. This session will make a distinction between nomenclatures and discuss the reporting requirements to the FDA and Office for Human Research Protections (OHRP).
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