Compliance in Research Activities

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Class Objectives:

• Provide a brief overview of research compliance activities at the University of Utah
• Understand the work of the units in the Human Research Protections Program (HRPP) at the University of Utah
• Explore how to access and use the information at ClinicalTrials.gov Foundations
• Determine the impact and importance of billing compliance
• Consider and articulate sponsor expectations for compliance
• Differentiate the types of compliance activities that are forthcoming through OnCore
• Highlight the various resources available to ensure compliance activities in the research context

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The purpose of this class is to provide you with the requirements for source documentation based on applicable regulations. These requirements and the collection of clinical research data for investigator-initiated studies, as well as research sponsored by industry and government, will be presented. How to properly document data and prepare forms to serve as source documents will be described. Examples of templates and forms will be provided.

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ClinicalTrials.gov is a registry of federally-funded and privately-supported clinical trials that are conducted around the world. This registry provides information about a study’s purpose, inclusion/exclusion criteria, locations, contact information, results, and adverse events experiences by study participants.

Participants in this class will be able to describe the history behind ClinicalTrials.gov, including the rules and regulations that lead to its advent and expansion. Participants will also learn which University studies are required to be registered in ClinicalTrials.gov and what is required to update the study according to regulations.

The uTRAC system will be introduced, providing information regarding how it assists with decision-making for ClinicalTrials.gov requirements and appropriate information to meet clinical billing requirements. Participants will have a hands-on experience where they will be able to use ClinicalTrials.gov to enter a sample study.

This class is designed and best suited for users and departmental ClinicalTrials.gov administrators.

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This class provides a high level overview of general research compliance expectations when engaging in human subject research with a particular emphasis on interventional clinical trials. This includes the requirements for study activation, study management, as well as monitoring and data and safety monitoring oversight. Engaging in clinical research activities takes a village of people including the medical care team, coordination, regulatory, finance, investigational pharmacy, specimen processing, etc. Ensuring that clinical research activities are carried out compliantly with the highest ethical and regulatory standards and regulations protects our patients and our communities.

At the conclusion of this class, you should be able to:

• Understand the ethical and regulatory expectations for opening a new clinical trial
• Identify who is ultimately responsible for ensuring protocol compliance at a site level
• Describe the informed consent process
• Produce examples of types of reportable events
• Explain how we ensure data integrity and source documentation in clinical trials                
• Summarize why data and safety monitoring oversight is important and the difference between quality and compliance

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Unanticipated problems in research involving risk to human subjects or others must be reported to the Institutional Review Board (IRB). An "Unanticipated Problem" includes some types of adverse events, protocol deviations, non-compliance, and other incidents that place individuals at risk of harm.

This presentation will include advanced case studies involving IRB reporting policies for unanticipated problems. The criteria for reporting an unanticipated problem, including various definitions and guidance contributing to the interpretation of the criteria, will be discussed.

Participants will learn how to apply the criteria for an unanticipated problem in different scenarios and will better understand how to provide complete and accurate information in the IRB Report Form for complex unanticipated problems.

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red 304
(synchronous)    ENROLL FOR
RED 380
(AYNCHRONOUS)

What does it mean to manage and share research data? What are best practices for developing data management plans and increasing access to the results? How are human subject and qualitative research data managed in the social & behavioral sciences and humanities?

This informative presentation will explain the motivations behind federal mandates and University policies regarding open data sharing. Participants will learn practical data management skills including file naming, version control, creating data management plans, and crafting subject-specific metadata in the Data Documentation Initiative (DDI) format.

Data archiving options for institutional repositories will be discussed and University data planning, analysis, and archiving services available throughout the research data lifecycle will be described.

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RED 303
(synchronous)      - COMING SOON -
RED 365
(ASYNCHRONOUS)

Rigor and reproducibility of research is critical to the advancement of science. Irreproducibility of research, in particular clinical research, is a growing concern as valuable time is wasted pursuing false leads and consuming significant resources, often from publicly-funded federal grantees. 

Various efforts in academia and the scientific community are underway to improve the transparency and robustness in publications and to promote a cultural shift. This presentation will provide an introduction to the problem of irreproducibility, define key terms and concepts, and describe emerging tools and tactics for supporting and encouraging rigor and reproducibility in research. 

The Open Access movement and the latest guidelines and policies from the National Institutes of Health (NIH) will be discussed including new review criteria for grant proposals.

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The process of informed consent will be considered from the research participant's perspective. What is Good Clinical Practice (GCP) when addressing participant questions and concerns? How can the informed consent process be improved for the participant? What do your participants truly understand, consent to, and wish they knew more about? How does Health Literacy impact the informed consent process in clinical research? What is therapeutic misconception and how can it be avoided?

These questions and other "hot topics" will be the focus of discussion in this open forum presentation.

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Participants should have a basic knowledge of informed consent requirements prior to attending this class.

Different models for obtaining and documenting informed consent based on the required elements and risk level of the research will be presented. The difference in required elements of consent for minimal risk and greater than minimal risk studies will be explained. How to improve the informed consent process and required documents through clarification and simplification will be discussed.

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An introduction to clinical trial FDA inspections. This course will cover how to prepare for an FDA inspection, what to expect during the inspection and how to plan for improvement based on the final FDA report.

At the conclusion of this class, you should be able to:

• Describe the reasons for and purpose of an FDA Inspection
• Review how to best prepare for an FDA inspection
• Articulate what to expect during an FDA inspection
• Discuss how to improve internal practices based on the outcomes of the inspection

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REd Best Practice Networks are 1 hour in length with a 15-minute presentation and a 45-minute discussion that are led by subject matter experts. They will be developed based on (1) requests from participants and (2) needs from units on campus. Participants are expected to come prepared with any questions that they may have and to engage in a conversation with the facilitator and their peers.