This page lists clinical research training from external groups, instructor-led DOCR courses, and online DOCR courses. Onboarding materials for clinical research professionals and training by competency can be found on the WE-R Onboarding and Training page.
External Training Available for Clinical Research Staff
Additional training for clinical research staff is available on the Society of Clinical Research Sites website. These online training modules are designed to provide staff with foundational knowledge and skills to conduct clinical research studies in compliance with federal regulations. The website includes modules on Good Clinical Practice, human subjects protection, and study management. Staff can access the training at their convenience.
Duke has purchased the all-access webinar package from CITI. There are over 120 webinars to choose from on various research topics! Here is a tip sheet for adding the webinars to your Duke Health CITI Account.
You can find webinars that are currently available listed on the CITI Website. Additionally, DOCR has organized them all by clinical research competency and domain for you in this spreadsheet. The spreadsheet can be filtered by domain, competency, or webinar title.
The below online CITI modules are optional learning. Visit the CITI Training page to review information about required CITI modules.
| Course name | Instructions |
|---|---|
| Practicing Community-Engaged Research (ID13473) |
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| Ethics in Community-Engaged Research (ID13554) |
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| Race in Clinical Research: Ethics and IRB Decision Making |
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Virtual Instructor-Led DOCR Courses
The DOCR instructor-led classes are offered virtually (via Zoom). If you are registered for a DOCR virtual class, you will receive an e-mail communication a day or two before your scheduled class with Zoom call-in information. Questions should be directed to docr.help@dm.duke.edu.
The following courses are electives in the Engagement, Recruitment, and Retention certificate program and are open for any clinical research staff to enroll.
| Title | Upcoming Training Sessions | Class Time |
|---|---|---|
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Social Media: Is it Right For Your Research |
8:30 AM | |
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Community Engaged Research Initiatives |
8:30 AM | |
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Telling the Story of Your Research |
8:30 AM | |
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Engagement, Recruitment, and Retention on a Shoestring Budget |
8:30 AM | |
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Remote Informed Consent: Best Practices in Design and Delivery
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8:30 AM |
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The 5Ts: A Framework to Support Inclusion of Older Adults in Research |
2:00 PM |
Online DOCR Courses
PLEASE NOTE: If you experience issues with your E-Learning training session, please select a different browser (Chrome and Firefox tend to perform best with LMS training).
This online training is intended for clinical research personnel at Duke who will request access for Adobe Sign from the Duke Office of Clinical Research.
Course Objectives:
- Define Adobe Sign
- Describe how you can and cannot use Adobe Sign
- Differentiate between e-signatures and digital signatures
- Find tools and resources
The online course is designed to help clinical research study teams understand adverse events and the processes surrounding them at Duke. The module addresses identifying adverse events for research studies, collecting and documenting data regarding adverse events, and reporting these events to different governing bodies.
The course provides guidance to help develop a baseline in the following WE-R clinical research competencies:
- Safety and Ethics: Adverse Events
- Safety and Ethics: Sponsor/Regulatory Reporting
This online course is designed to help study teams understand the basics of budgeting and payment terms for industry-sponsored clinical trials/research. Learning Objectives - Upon completion of this module, you will be able to:
- Identify the study documents to review when developing a budget
- Describe the types of costs associated with conducting a study
- Recognize CRU Management Fees and Duke’s Facilities & Administrative Costs (F&A)
- Discuss tips for negotiation
- Discuss common negotiation mistakes
- Recall preferred payment terms
The information in this online course will help Duke Clinical Research Professionals (CRC, CRNC, REG C, and RPL) prepare a portfolio for Tier Advancement into the highest tier for their role.
Upon completion of the online module, you will be able to:
- Describe the purpose of a professional portfolio
- Recognize types of portfolio submissions for Tier Advancement and required items for each
- Discuss the portfolio review process
- Identify strategies to build a successful portfolio and impress your audience
This self-paced online module will provide clinical research internship preceptors with an understanding of what it means to host a clinical research intern, intern preceptor responsibilities, what a successful internship looks like, and how to determine what activities interns can participate in. Preceptors of clinical research interns who are onboarded through the Clinical Research Internship Portal (CRISP) will be required to complete this online module before requesting an intern.
Learning Objectives:
- Recognize the purpose of a clinical research internship
- Determine whether your study supports the learning environment required to host an intern and achieve internship objectives
- Recognize the responsibilities of the various members of an internship team
- Identify study tasks that interns can help with
- Recall boundaries for intern access to study data and protected health information (PHI), including patient health records
- Describe a successful internship experience
- Find guidance for engaging with the Clinical Research Internship Portal (CRISP)
This self-paced online module will help clinical research interns think critically when they are in certain situations during an internship. They will learn about taking a “Time Out” when they are interacting with information about the study and study participants and if they come in contact with sensitive data. This training is required for clinical research interns onboarded through the Clinical Research Internship Portal (CRISP) upon initiation of their internship with a clinical research team at Duke.
Learning Objectives:
- Define “Time Out”
- Recognize Time Out Moments when they should always stop and think before moving forward
- Identify where to seek assistance in moments of uncertainty
- Describe why this practice is important to minimize risk and protect participants
This online course is designed to provide study teams with an overview of recruitment planning at Duke. The course includes information about the Engagement Policy, obtaining IRB approval for your recruitment plans and materials, branding requirements when you’re targeting Duke Health patients, and Maestro Care tools that support your efforts to identify people who are eligible for your studies.
- Discuss Duke policies related to recruitment and engagement.
- Recognize the importance of planning for recruitment.
- Recognize the process for obtaining IRB approval for recruitment plans and materials.
- Recall branding requirements when recruiting Duke Health patients.
- Discuss Maestro Care tools as a means to identify eligible participants.
This online module will provide an introduction to ClinicalTrials.gov and cover why it is important to register and report results, who is responsible, when to register, and the Duke process.
This module will walk you through who can register trials in ClinicalTrials.gov, what information is included in a registration, resources to help with registration, and what is required for record maintenance once a trial is registered.
This module will cover which studies must submit results, what information is required for results submission, when to submit results, and Duke's process for results submission.
This online course was developed in collaboration with CTSI Community Engaged Research Initiatives and Workforce Development cores and highlights key concepts related to community and stakeholder engagement in research. Upon completion of this course, you will be able to:
- Define community- and stakeholder-engaged research
- Discuss the importance of community- and stakeholder-engaged research in addressing health disparities
- Discuss the importance of community-engaged research in fostering trust and transparency
- Recognize stakeholders who should be engaged in research
- Identify principles of community- and stakeholder-engaged research
This is an online course for new employees who need to create a CITI account and other employees who need to update their CITI account institutional email address to ensure proper linking with other Duke systems (i.e. iRIS).
This online module is designed to provide study teams with fundamental or refresher information on developing the informed consent form. Upon completion you will be able to develop the informed consent form to meet Duke Health IRB and federal standards.
Course Objectives:
- Discuss the purpose of informed consent and of documentation
- Identify and define the elements of the informed consent form
- Identify and interpret policies and regulations related to the informed consent process and Health Insurance Portability and Accountability Act (HIPAA)
- Describe requirements related to ensuring participant comprehension of informed consent and ICFs (e.g., reading level and translation requirements)
This online course will provide Duke Clinical Research Managers with resources, best practices, and communication tips for potentially difficult conversations they may face before, during, and after the Tier Advancement process.
Learning Objectives:
- Facilitate conversations with employees regarding the Tier Advancement Process
- Recognize the importance of ongoing conversations regarding competency and performance throughout the year
- Identify ways to assist employees in developing new competencies to foster continued professional development
- Discuss strategies for developing a career progression plan to prepare employees for their career path and Tier Advancement
This online module reviews the elements of effective eConsent design and delivery to support effective informed consent to clinical research. Upon completion of this online module, you will be able to describe these elements, including: cognitive load, multimedia, interactivity, and user-centered design. This module is system agnostic, so it is not specific to using REDCap to create an eConsent. Rather, it covers how to use what we know about learning to develop an eConsent that enhances participant understanding.
Learning Objectives:
- Define eConsent
- Discuss basic concepts of cognitive load
- Discuss basic concepts of multimedia theory
- Define interactivity
- Discuss components of user-centered design
Express Start for CRC consists of four self-paced online modules that will provide an overview of clinical research activities, regulations, and workflows at Duke.
Learning Objectives:
- Describe the roles and responsibilities of a Clinical Research Coordinator
- Identify the clinical research offices and resources within Duke Health
- Identify the clinical research systems used at Duke and understand how they interact with one another
- Discuss the studies that make up your research portfolio
- Describe the career progression within clinical research professions
Visit the DOCR WE-R Onboarding and Training for Clinical Research Professionals webpage to find more onboarding tools and templates.
The Express Start Onboarding Program for CRNCs consists of four self-paced online modules that will provide an overview of clinical research activities, regulations, and workflows at Duke.
Learning Objectives:
- Describe the roles and responsibilities of a Clinical Research Nurse Coordinator
- Identify the clinical research offices and resources within Duke Health
- Identify the clinical research systems used at Duke and understand how they interact with one another
- Discuss the studies that make up your research portfolio
- Describe the career progression within clinical research professions
- Define nursing responsibilities, competencies, and credentialing for the CRNC role
Visit the DOCR WE-R Onboarding and Training for Clinical Research Professionals webpage to find more onboarding tools and templates.
The Express Start for CRS consists of three self-paced online modules that will provide an overview of clinical research activities, offices, and workflows at Duke.
Learning Objectives:
- Describe the roles and responsibilities of a Clinical Research Specialist
- Identify the clinical research offices and resources within Duke Health
- Identify the clinical research systems used at Duke and understand how they interact with one another
Visit the DOCR WE-R Onboarding and Training for Clinical Research Professionals webpage to find more onboarding tools and templates.
This online course will acquaint new Clinical Research Unit (CRU) Directors (also referred to as CRU Medical Director) with the structure and expectations of their role within the CRU, the responsibilities of the other roles within the CRU, support available across Duke for clinical research, and other items that are important for the CRU Director to know. The course is intended for CRU Directors or others acting in a similar capacity for a CRU.
LESSONS:
- Welcome to your new role,
- CRUs and OOs,
- Your role as CRU Director,
- Clinical research roles within your CRU,
- Clinical research support offices at Duke,
- Intro to Workforce Engagement and Resilience,
- Getting started in your role.
Visit the DOCR WE-R Onboarding and Training for Clinical Research Professionals webpage to find more onboarding tools and templates.
New Manager Express Start comprises three self-paced eLearning modules tailored for individuals stepping into management roles within clinical research at Duke. These modules are designed to complement the role-based Express Start Onboarding modules for Clinical Research Professionals (CRPs) and offer guidance for managing and supervising teams effectively. Through completing these modules, new managers will gain insights into their general responsibilities and acquire strategies for leading and retaining CRPs. This training will be helpful for new CRPs hired into a manager role, CRPs transitioning into manager roles, and seasoned managers seeking a refresher.
Click here for an outline of what is included in New Manager Express Start.
Visit the DOCR WE-R Onboarding and Training for Clinical Research Professionals webpage to find more onboarding tools and templates.
Express Start for Regulatory Coordinators consists of four self-paced online modules that will provide an overview of clinical research activities, regulations, and workflows at Duke.
Learning Objectives:
- Describe the roles and responsibilities of a Regulatory Coordinator
- Identify the clinical research offices and resources within Duke Health
- Identify the clinical research systems used at Duke and understand how they interact with one another; with a spotlight on iRIS
- Find and follow applicable standards, guidelines, regulations, policies, and procedures for performing clinical research at Duke
- Describe the career progression within clinical research professions
Visit the DOCR WE-R Onboarding and Training for Clinical Research Professionals webpage to find more onboarding tools and templates.
Express Start for RPL consists of five self-paced online modules that should be completed by individuals hired into the RPL and RPL Sr. positions at Duke. The WE-R Express Start Onboarding modules provide new hires in clinical research roles at Duke with an understanding of the “lay of the land” of clinical research at Duke. By completing these self-paced online modules, new RPLs will learn the basic information that will begin to prepare them to manage clinical research projects and programs.
Click here for an outline of what is included in RPL Express Start.
Learning Objectives
- Describe the roles and responsibilities of a RPL
- Identify the offices, programs, and resources that support clinical research at Duke
- Recognize the structure of your team and the roles you can expect to interact with
- Identify the clinical research systems used at Duke and recognize how they interact with one another
- Recall best practices for becoming familiar with your clinical research portfolio of studies
- Describe the fundamentals of project management in a clinical research context
Visit the DOCR WE-R Onboarding and Training for Clinical Research Professionals webpage to find more onboarding tools and templates.
Express Start for Research Practice Managers consists of five self-paced online modules that will provide an overview of clinical research activities, regulations, and workflows at Duke. By completing these modules, new CRU leaders will learn basic information that will begin to prepare them for their role as a RPM or ARPM at Duke.
Learning Objectives:
- Describe the roles and responsibilities of a RPM or ARPM
- Identify the offices, programs, and resources that support clinical research at Duke
- Recognize the structure of your team and roles you can expwct to manage and interact with
- Identify the clinical research systems used at Duke and recognize how they interact with one another
- Recall regulations, guidelines, and policies for conducting clinical research at Duke
- Describe the RPM and ARPM responsibilities related to WE-R initiatives and Tier Advancement for employees
Visit the DOCR WE-R Onboarding and Training for Clinical Research Professionals webpage to find more onboarding tools and templates.
This online course is designed to help participants understand the financial concepts associated with the life cycle of a clinical trial/research study.
Course Objectives:
- Describe clinical research from a financial perspective
- Describe the types of costs associated with a clinical trial/research study
- Describe the concept of effort management
- Describe financial and management reporting
- Describe financial close-out requirements
- Describe systems useful in following financial activities associated with a clinical trial/research study
This online module will help clinical research study teams identify the goals of research data management and summarize approaches for keeping data secure and avoiding errors. The learner will be able to define the reason for data management, describe best practices for storing and sharing data to ensure data integrity and security, define data collection methodology, describe database design best practices, and discuss tips and tricks for collecting data for research purposes.
NOTICE: This course is a pre-requisite for attending any DOCR REDCap courses.
This self-paced online module will provide clinical research interns with helpful information as they get started with their internship. Interns will learn about the purpose of a clinical research internship, the role of the intern, how to take ownership of the experience, and general professional expectations of interns. This training is required for clinical research interns onboarded through the Clinical Research Internship Portal (CRISP) upon initiation of their internship with a clinical research team at Duke.
Learning Objectives:
- Recognize the purpose of a clinical research internship
- Describe the role of an intern and how interns will interact with the study team
- Recall general professional expectations of a clinical research intern
- Describe strategies for taking ownership of the internship experience
- Use the internship learning agreement for professional development and goal-setting
This online course presents information regarding the contract approval process for industry-supported research, and details best practices for preparing a successful SPS entry for industry-sponsored research projects.
Course Objectives:
- Outline information regarding the contract approval process for industry-supported research that will enable getting the contract signed
- Detail best practices for preparing a successful SPS entry for industry-supported research projects
This course outlines the current threat landscape regarding information security and helps research staff identify ways to protect electronic information in both work and home environments.
Course Objectives:
- Identify the current threat landscape in the realm of information security
- Summarize the information security best practices for home and work environments
- List tips for protecting your assets when utilizing digital interfaces at home, work and in transit
- Recognize the use of "security language" in informed consent
- Summarize general information on cloud sharing, communication tools, mobile devices, and use of external vendors
This online course is intended for clinical research study teams and will help you understand planning for informed consent, the informed consent process, and documenting consent at Duke. Note: this course is required by IRB Policy for anyone who will consent participants to a research study.
Course Objectives:
- Identify the purpose of informed consent and informed consent documentation
- Identify and define types of consent and the elements of the informed consent form (ICF)
- List and describe supporting documentation of the informed consent process (e.g. consent forms, consent notes, waivers).
- Identify and interpret policies and regulations related to the informed consent process and HIPAA
- Describe requirements related to ensuring participant comprehension of informed consent and ICFs (e.g. reading level and translation requirements)
- Describe how the consent process is planned and diagnose errors in consent planning
- Describe the procedure for conducting and documenting consent for participants
This online course is intended for study team members at Duke who may consent participants to clinical research studies remotely/virtually and/or via eConsent. Remote means the consent process is not occurring in-person and eConsent means the process is occurring electronically.
Learning Objectives
- Define remote consent, eConsent, and virtual consent
- Recall IRB approval requirements for remote/virtual consent and eConsent processes
- Describe proper methods of consenting using these processes
- Describe the process of documenting remote consent in OnCore
This online course will provide Duke employees engaged in clinical research with information about regulations, guidelines, and policies for conducting clinical research at Duke University.
Learning Objectives:
- Find and follow applicable standards, guidelines, regulations, policies and procedures for performing clinical research at Duke
- Identify and interpret policies and regulations regarding Duke Health IRB oversight of research
- Describe study elements that must be approved by or reported to the Duke Health IRB
- Identify research approval elements and responsible offices at Duke
Competency(ies): Institutional Regulatory Policies and Procedures (IRPP)
This training is for investigators and research teams at Duke who will create eligibility source documentation for interventional clinical research studies with planned participant accrual. Interventional clinical research includes studies with an OnCore protocol type of Treatment, Prevention, Device Feasibility, Diagnostic, Screening or Supportive Care.
Learning Objectives
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Define study eligibility determination.
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Document study eligibility using two appropriate methods.
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Attest to your understanding of Duke policy related to documenting study eligibility.
This online course is designed to outline the basic process for IRB application submission using the iRIS system.
The module will describe the workflow among the two main research workflow systems iRIS and OnCore and will introduce users to the iRIS system, basic navigation and initial protocol submission.
This online course is intended to help clinical research personnel get started working with investigational products at Duke. Clinical research staff may be responsible for different aspects of managing and documenting an Investigational Product (IP) or Investigational Study Drug (ISD); including arrival, storage, tracking, provision to research participants, and (if applicable) return and/or destruction. These roles may also serve as the primary coordinator with study sponsors, Duke Department of Pharmacy Investigational Drug Services (IDSs), and other parties as necessary.
Learning Objectives:
- Identify and interpret policies for administration of investigational products (IP)
- Recognize when an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application is needed
- Describe study design requirements for studies involving IP
- Describe potential documentation requirements related to IP
- Identify personnel responsible for various IP management activities
- Describe requirements and processes for using the Duke Investigational Drug Services (IDSs)
This online course offers an overview of the DUHS IRB review process and requirements, federal regulations, and Duke policies pertaining to research involving human subjects. The course highlights tools available to study teams on the IRB website and provides strategies for working efficiently with the IRB.
Course Objectives:
- Describe the DUHS IRB’s scope of oversight – what does and what does not require review by the DUHS IRB
- Discuss the IRB review process
- Describe reporting to the IRB
- Recognize how to communicate with the IRB
- Find the many tools available on the IRB website
The online course is designed to provide study teams with an overview of the Just Ask concept, health disparities, health equity, and the current state of diversity in clinical trials. The online version of Just Ask begins to frame the ‘why’ around being mindful and intentional in our work to engage, recruit, and retain a diverse population of research participants. It also provides a few resources and ideas for how study teams can intentionally begin to incorporate a health equity and diversity lens into study plans.
Course Objectives:
- Define health disparities
- Differentiate between health equity and equality
- Recognize lack of diversity in clinical trials
- Discuss the importance of diversity in clinical trials
- Recognize your role and the study team's role in diversity planning for studies
The Workforce Engagement and Resilience (WE-R) team in DOCR collaborates with the Clinical Research Manager Training Committee and SOM HR partners to create periodic Manager Mini modules for the Clinical Research Update Newsletter. These training snippets offer timely tips for managers and can be completed in under 15 minutes.
| Disseminating Information to Your Team | 00197980 In this mini-module, you'll learn practical strategies to disseminate important information to your team so everyone is in the loop! |
Register |
| Crafting an Accountability Mindset | 00194481 In this mini-module, we'll explore what accountability is, why it's essential for your team's success, and 10 tips that can help you craft an accountability mindset for your team. |
Register |
| Strategies to Support Employee Engagement and Retention | 00192028 In this mini module, you’ll learn about types of employee turnover and review the top reasons employees disengage. Then, review strategies for keeping your team engaged including resources and tips suggested by your colleagues. Managers will receive downloadable tools to start off strong with new team members and a "Motivational Audit" to gauge current employee engagement. |
Register |
| Feedback and Feedforward | 00190279 In this mini-module, we will review types of feedback, a process you can use to provide feedback, how to deliver your message effectively, and tips to deal with certain responses. Managers will receive a downloadable 10-Step Process Checklist for providing feedback. |
Register |
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Conducting Effective One-on-One Meetings | 00189214 |
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Balancing Priorities and Managing Your Time | 00189480 |
Register |
This online module provides instruction for new clinical researchers who will work in a Clinical Research Coordinator (CRC) user role or as a refresher for existing clinical research staff. Research Dashboard and system functionality will be reviewed in the module. This course, as well as passing an end-of-course test, is a requirement for CRC access to Maestro Care.
This module covers:
- The Research Dashboard
- Enrolling Patients in Studies
- Order Management
- Encounters-linking
- Conducting and Documenting a Patients Study Visit
- Navigating the In Patient Record- Chart Review
This instructor-led hands-on workshop module is for licensed Maestro Care Oncology nurses. A follow-up session is scheduled one on one at-elbow. This class was developed to:
- Close gaps and include specifics for CRC oncology workflow
- Develop targeted oncology-specific training for CRCs
- Reduce number of training hours previously required as ambulatory training
Course covers:
- The Research Dashboard
- Enrolling Patients in Studies
- Applying a Research Treatment Plan
- Navigating and working with the Research treatment plan
- Research Oncology workflow
The course concentrates on the Maestro Care Beacon workflow for Oncology CRCs including adding treatment plans, navigating and managing the treatment plan, associating and linking information, and navigating through patient records. Practical exercises and instruction provide the participant with tools and examples for reference at the end of the course. This course, Maestro Care Clinical Research 100, as well as passing an end-of-course test, is a requirement for Oncology CRC access to Maestro Care.
The DOCR Maestro Care Clinical Research 'View Only' (web-based) Module is required for staff requiring View Only Access with no editing or data entry capabilities.
This module covers:
- General Overview
- Access to terminology
- General navigation
This online training course is intended for administrative leadership in Duke School of Medicine who are granted organizational access in the OnCore system (Dean, Assistant Dean, Chairmen, Business Managers, other central office staff).
This designated role in OnCore will be able to view protocols in the PC Console, view accrual and enrollment information on clinical research studies, and generate and schedule administrative reports for departments and units at Duke.
This module covers:
- Administrative Leadership Overview & Using the PC Console
- Using the Accrual Monitoring Console
- Reporting Functions
This online module is a prerequisite for all OnCore Training courses. Participants will be able to recognize and recall basic navigation functions within OnCore (Duke CRMS).
OnCore Basic Navigation is required as a prerequisite for all OnCore training classes.
This module covers:
- What is OnCore?
- Basic OnCore Navigation
- Customizing the OnCore Dashboard
- Consoles
- Date Widgets & Shortcuts
This online training course provides an overview of OnCore for Principal Investigators. Participants will be able to recognize and recall basic navigation to the PI Console and Reports sections of the OnCore system for study management.
This online training course will provide step by step instructions on completing specific tasks relevant to the basic function(s) of a Clinical Research Coordinator at Duke.
This module covers:
- Subject Administration
- Subject Calendars & Tracking
- Reporting
This online training course will provide step by step instructions on completing specific tasks relevant to the basic function(s) of a Clinical Research Regulatory Coordinator at Duke.
This module covers:
- Regulatory Workflows at Duke
- Using the PC Console
- Reporting Functions
This online training course will review how to setup the Study Information Portal (SIP) console in OnCore. Information entered into the SIP console is pushed to the dukehealth.org website where the community can easily search for available research studies.
This course provides training and verifies competency for research personnel (not otherwise licensed or certified) to perform venipuncture on adults. Upon completion of the course, personnel may perform venipuncture in a research environment at Duke Medicine. This course does not train the participant to be a phlebotomy technician or provide formal certification.
This course describes the process for safely completing a venipuncture, lists the supplies needed, the acceptable sites for venipuncture, the labeling process of tubes for Duke and other labs, the potential complications, and provides an opportunity to practice venipuncture under instructor supervision.
Manager approval required to attend this class.
Course Objectives:
- Describe the process for safely completing a venipuncture on an adult
- List the supplies needed to accomplish venipuncture
- Identify the common sites for venipuncture and sites not acceptable for venipuncture
- List the correct order of tubes for blood collection
- Describe the labeling process of tubes for both Duke and other labs
- Discuss potential complications
- Perform venipuncture with instructor supervision
This online course is designed to outline the basic functions of post-approval submission forms using the iRIS system including:
- DUHS IRB Amendment Forms
- DUHS IRB Migration Amendment Forms
- DUHS IRB SAE/AE Forms
- DUHS IRB Continuing Review Forms
- DUHS IRB Study Closure Forms
- DUHS IRB KSP Forms
This online course describes the process for documenting a Preconsent status in Maestro Care for those protocols that have IRB approval for this process.
Learning Objectives:
- Perform the correct workflow for documenting Preconsent statuses in Maestro Care.
- Finding the Preconsent status on the Research Studies screen. Competencies: Electronic management of research participants' consent procedures.
This 10 minute online module will walk you through protocol deviations and their counterparts protocol violations, adverse events and unanticipated problems, and the subsequent steps of reporting these events to the IRB.
By the end of this module, you will:
- Recognize what constitutes a protocol deviation, violation, adverse event, and unanticipated problem
- Recognize what events need to be reported to the IRB
- Recall the reporting timeframe for these events
- Attest to abiding by the policy requirements detailed in Problems or Events that Require Prompt Reporting to the IRB.
This module is required annually of all WE-R Clinical Research Professional job classifications.
Race is embedded in how we are trained to practice medicine. How we define it, who defines it, and how such emphasis affects clinical decision making is changing how we practice medicine. But clinical practice starts with evidence derived from research. This webinar explores how the concept of race is used in clinical research, and the ethical and regulatory questions we need to confront.
To find the new course, log into your Duke Health CITI profile at https://about.citiprogram.org/ and click “View Courses”. Then click “Add a Course” near the bottom of the page, and select “Race in Clinical Research: Ethics and IRB Decision Making” from the next page. The course will appear on your Duke Health profile page under “Courses Ready to Begin”.
This online module was developed in collaboration with the RIC, DOCR, and DCRI and takes about 25 minutes to complete. The purpose of this online module is to provide clinical research staff with the foundational information needed to create readable engagement materials for clinical research studies. There are resources, tools, and tips within this module that will help clinical research personnel work through this critical part of their role.
Learning Objectives:
- Define readability and health literacy
- Recognize the fundamentals of readability in the context of clinical research
- Recognize the importance of producing materials that participants can understand
- Identify ways to assess the readability of materials and confirm participant understanding
The content provides guidance to help the following WE-R clinical research competencies: Recruitment, Participant Retention
You can also find this course on the DOCR WE-R Competency Training page under the Recruitment and Participant Retention competencies.
To align with the revised DUHS Notice of Privacy Practices, the IRB Recruitment and Engagement Policy allows study teams to use various methods to engage patients in research related to their health, if approved by the DUHS Institutional Review Board (IRB). Training on the Recruitment and Engagement policy implemented in 2020 is required prior to the IRB approving recruitment plans utilizing expanded recruitment options.
Learn to use a Microsoft Excel file to build or modify the structure of your database in a concise format. The data dictionary is the preferred method of creating your database. This method makes it easy and quick to create many variables, and use advanced functionality (branching logic or calculated fields).
Learn how to build reports and view/export your project data/results in just a few steps!! You can also use the interactive Data Import tool is used to upload data from a comma-delimited (CSV) file, into your REDCap project. Instead of entering records one by one, you can use the import tool to upload multiple records at once.
Learn what it takes to make your surveys as efficient as possible. Customize survey settings, manage survey participants, and stay up-to-date on survey progress and results.
In this workshop, learners will create a project using REDCap.
Course Objectives:
- Practice building in REDCap, including the application of field types, validation, and branching
- Identify REDCap features and determine how to apply these features to a range of projects
- Summarize the steps for moving projects to production
- Identify best practices for collecting data
Completion of the Fundamentals of Clinical Research Data Management & Collection course is a prerequisite for this course.
This online course will guide clinical research study teams through the basics of regulatory study closeout.
Course Objectives:
- Prepare studies for regulatory closeout as dictated by institutional guidelines
- Recall the basics of document storage
This online course is an overview of typical clinical research-related contracts and agreements and how they are handled at Duke, along with an introduction to the Duke Office of Research Contracts (ORC).
Course Objectives:
- Identify typical agreements/contracts (MTAs, CTAs, CDAs, DTAs)
- Recognize when typical agreements are necessary
- Describe processes for putting agreements in place
- Discuss tips and tricks for designing databases for research purposes
- Identify special considerations and tips when establishing an agreement
This online module will walk you through the expectations and requirements to serve in the role of Principal Investigator in Human Subjects Research at Duke Health.
Course Objectives:
- Recognize the responsibilities of the DUHS Principal Investigator
- Recognize the requirements of the DUHS Principal Investigator agreement and know where to find it
- Recall the Duke specific required training for those serving in the Principal Investigator role
- Recognize Duke offices and resources available to Principal Investigators and know whom to contact for assistance
This online module was developed in collaboration with the RIC, DOCR, and CERI and takes about 20 minutes to complete. The purpose of this online module is to reviews the strategies clinical research teams can implement to support retention of clinical research participants. There are resources and tips shared within this module that will help clinical research personnel work through this critical part of their role.
Course Objectives:
- Define participant retention
- Describe strategies for retention and their importance
- Identify ways to set clear study expectations to support retention
- Discuss the importance of study continuation with participants
You can also find this course on the DOCR WE-R Competency Training page under the Participant Retention competency.
This online course outlines the required components of study documentation for all clinical research, defines standard documentation terminology, and applies knowledge of documentation best practices to everyday scenarios faced by study teams.
Course Objectives:
- Outline required components of study documentation for all clinical research
- Distinguish between documentation regulations and best practice
- Define standard documentation terminology
- Apply knowledge of documentation best practices to day-to-day documentation scenarios faced by study teams
This micro-learning video will (1) provide updated instructions for completion of the Subject Visit Update Screen. (2) help you understand the impact of subject visit tracking on Oncore Financials. (3) Review best practices and their importance in avoiding critical billing errors.
This self-guided course provides a detailed look at the manager-scored Self-Report Assessments used during the Tier Advancement process for clinical research professionals at Duke. This course is intended for managers and employees, to understand how the form is completed by employees, and how the form is used by the manager to assess competency level and provide a final score.
This course reviews workflows for adding timelines, research associating orders and linking appointments & encounters in Maestro Care. These workflows may be in support of the following WE-R competencies: *Electronic management of research participants
This is the final component necessary to complete before undergraduates will be allowed to consent people to a limited scope of research studies. Pre-requisites to completing the competency check off are review of the DUHS IRB policy “Duke Undergraduates Engaged in the Consent Process on DUHS IRB Protocols,” completion of the Duke Medicine CITI modules, and the online DOCR Screening and Consenting class. Upon completion of the competency check off, students will need to be mentored by their PI/Department before being allowed to consent people to a limited scope of research studies as defined in the course.
Study personnel who will be supervising these undergraduates should contact docr-training@duke.edu for the competency list and instructions for completing it with their students.
Course Objectives:
- Define types of studies to which undergraduate students can and cannot consent participants
- Define which participants undergraduate students can and cannot consent to studies
- Demonstrate knowledge of the informed consent process by consenting class participants to a sample study
This online course provides a simulation of the updated research billing review process in Maestro Care. Participants will practice the steps using the "Patients Needing Coordinator Review" Report (RSH005) and be guided to success.
Course Objectives:
- Generate the RSH005 report
- Review the charges for an individual research patient
- Mark any corrections to a research patient's charges
This course outlines the requirements for conducting urine pregnancy screening for research and discusses how this differs from urine pregnancy testing performed for clinical care. Participants will practice pregnancy screening on the QuickVue OneStep. The QuickVue OneStep and the QuickVue OneStep + are the only DUHS IRB approved kits for pregnancy screening for research.
Course Objectives:
- Outline the requirements for conducting urine pregnancy screening for research
- Discuss how urine pregnancy screening for research differs from urine pregnancy testing performed for clinical care
- Demonstrate competency with the Quidel Urine Pregnancy kit by performing one positive and one negative result and documenting the results on the hCG-Results QC log sheet
This online module will describe the purpose of recruitment using social media and provide an overview of questions to ask to help determine whether study teams should use social media as a recruitment tool.
Learning Objectives:
- Describe how social media is used for recruitment in research studies.
- Identify questions to determine whether social media is right for a study.
- Find policies and procedures related to using social media for recruitment at Duke.