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Trainings for UNC Research Personnel

The videos below were created by various groups and individuals at UNC-Chapel Hill, and are available for UNC research personnel to use for training purposes. If you have any questions regarding the content, please contact the presenter (or presenter’s office) directly. If you have questions regarding this webpage or have suggestions for future trainings, please email Catherine Barnes at catherine_barnes@med.unc.edu.


Orientation for New Clinical Research Personnel

Orientation Day 1

This module discusses the research landscape at UNC-Chapel Hill, the research study life cycle, different types of research studies, and good clinical practice (GCP).

Presenters: Juanita Cuffee and Catherine Barnes | Date: November 9, 2021

Orientation Day 2

This module gives an overview of research regulations, research processes, research roles and responsibilities, and informed consent.

Presenter: Catherine Barnes | Date: November 10, 2021

Orientation Guide

The Orientation Guide includes the orientation schedule, basic information about conducting research at UNC-Chapel Hill (including common acronyms and information about the UNC-Chapel Hill research offices), and specific learning resources from the sessions.

Orientation for New Clinical Research Personnel Resource Guide v08Nov2021

Study Start-Up

Study Start-Up and Implementation

This module covers the time period between feasibility assessment and study enrollment, including how to conduct an appropriate feasibility assessment and how to prepare for study execution.

Presenter: Laura Viera | Date: April 14, 2021


Study Personnel Roles and Management

Study Team Responsibilities

This module covers the various roles in study teams, including a deep dive into the roles of a study coordinator.

Presenter: Laura Viera | Date: April 14, 2021

Sponsor-Investigator Responsibilities

This module covers the responsibilities of a site Principal Investigator (as outlined by the Office of Human Research Protection, the Food and Drug Administration, and Good Clinical Practice), the definition of a Sponsor-Investigator, and how a Sponsor-Investigator’s responsibilities differ from that of a site Principal Investigator.

Presenter: Valorie Buchholz | Date: April 21, 2021


Regulatory

UNC Institutional Review Board: Processes and Function

This module covers the history of human subjects research, research regulations and protections, and the Office of Human Research Protections (OHRE) at UNC. In addition, students will also learn about the different levels of Institutional Review Board (IRB) review, exempt and expedited review, waivers, annual reviews, and what to do when you receive contingencies from the IRB.

Presenter: Office of Human Research Ethics | Date: March 24, 2021

UNC Institutional Review Board: Application Submission Process, Navigating the IRB Website, and Ancillary Reviews

This module covers various ancillary reviews (e.g. scientific review, radiation safety) that must be completed at UNC, how to navigate the UNC IRB website, and how to submit an application to the IRB using the IRBIS system.

Presenter: Office of Human Research Ethics | Date: March 24, 2021

UNC Institutional Review Board: Reliance Agreements

This module covers what a IRB reliance agreement is, the various types of reliance agreements, and how to request a reliance agreement through the IRBIS system.

Presenter: Office of Human Research Ethics | Date: March 24, 2021

ClinicalTrials.gov

This module covers the ClinicalTrials.gov registration and reporting system, including what is defined as a “clinical trial”, when to register, how to get started, and record upkeep.

Presenter: Monica Coudurier | Date: April 21, 2021

OHRE SOP 1401: Promptly Reportable Information

A new version of UNC OHRE SOP 1401 went into effect on October 1, 2021. 

You may view slides and a presentation regarding the updated SOP on the OHRE website.


Safety Documentation

Adverse and Safety Event Evaluation and Documentation

This module covers the definition of a safety/adverse event, why we monitor safety events in clinical research, and who evaluates events. In addition, this module details how to document and track events, as well as what events should be reported to various groups.

Presenter: Marie Rape | Date: April 21, 2021


UNC Ancillary Committees

Carolina Data Warehouse

This module covers how to use the Carolina Data Warehouse for study recruitment.

Presenter:Emily Olsson | Date: April 14, 2021

Investigational Drug Services (IDS)

This module covers UNC Investigational Drug Services operations and billing.

Presenter: Investigational Drug Services | Date: April 14, 2021


Epic/Hospital Billing

Health Information Management’s Role in the Research Process

This module covers what Health Information Management (HIM)’s role is and what they are able to do for UNC research personnel. It also describes how to upload research consents to a participant’s Epic record, and how to request monitor access to the electronic medical record.

Presenter: Catherine Barnes | Date: March 31, 2021


Drugs and Devices

Investigational New Drug and Investigational Device Exemption Studies at UNC

This module briefly covers the definition, preparation, and maintenance of Investigational New Drug (IND) and Investigational Device Exemptions (IDE) at UNC. For more detailed information on INDs and IDEs, visit the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) website at regardd.org/videos.

Presenter: Marie Rape | Date: April 21, 2021

Investigational Device Management Policy

This modules covers investigational devices and UNC’s investigational device policies. In addition, students will also learn about the intricacies of investigational device start-up and management.

Presenter: Marie Rape | Date: April 14, 2021


Finance and Contracting

Budgeting and Accounting of Research Funds

This module covers the budget development process, how to determine various costs in the budget, invoiceable items and the tracking and invoicing for research funds.

Please note that the Office of Clinical Trials have changed their administrative fees (i.e., removing the separate BCA and IRB fees noted in this presentation). Please contact the Office of Clinical Trials for additional information.

Presenter: Jillyan Cunnup | Date: April 7, 2021

Preparing and Executing NIH Grant Budgets

This module covers the differences in budget preparation between NIH vs. industry sponsored trials. It also helps students identify resources and tools to assist in preparing budgets, and identify costs that may be charged to the department.

Presenter: Cassandra Barnhart | Date: April 7, 2021

Contracts and Clinical Trial Agreements

This module provides an overview of clinical trial agreements (CTA) including how to submit a CTA, the CTA negotiation process, and critical CTA provisions.

Presenter: Office of Industry Contracting within OSR | Date: April 7, 2021

Billing Coverage Analysis

In this module, students will learn the definition and importance of billing coverage analysis, the definition of a qualifying clinical trial, and the billing coverage analysis workflow.

Please note, as of April 11th, 2021, the billing coverage analysis workflow changed. This presentation covers both the pre- and post-April 2021 workflow. If you have additional questions about the billing coverage analysis workflow, contact the Office of Clinical Trials.

Presenter: Andrea Eiring | Date: April 7, 2021


Recruitment

Recruitment Procedures and Recruitment Services at UNC

This module covers various approaches to recruitment and recruitment services in NC TraCS.

Presenter: Emily Olsson | Date: April 14, 2021


Other Modules

Running a Clinical Trial from CDA to Study Closure

This module covers the importance of clinical research at UNC and describes the study coordinator’s role in a clinical trial. In addition, students will also review the steps for successful clinical trial implementation from study start-up through study closure.

Presenter: Chris Nelson | Date: March 17, 2021

The RCMU is supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR002489.

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