DOCR Training and Courses

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Onboarding materials for research staff and training by competency can be found on the WE-R Onboarding and Training page.

 

Until further notice, all DOCR instructor-led classes will be offered via WebEx/Zoom ONLY.  If you are registered for a DOCR instructor-led class, you will receive an email communication the day before your scheduled class with WebEx/Zoom call-in information.  Questions should be directed to docr.help@dm.duke.edu

 

Adobe Sign Training for Clinical Research - DOCR | 00147697 | Web-based offering

This 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

Register

Adverse Events: Identify, Document, Report - DOCR| 00147847 | Web-based offering

The 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

Register

 

Budget and Payment Terms Basics for Industry-Sponsored Clinical Trials - DOCR | DOCR-RES-145 | Web-based offering

This 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

Register

 

Clinical Research Recruitment Regulations and Tools - DOCR - 00153576

The 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.

Register

ClinicalTrials.gov Registration and Results Submission Overview  | DOCR-RES-790

This course will describe ClinicalTrials.gov, when and how to register a study on the site, and review FDAAA and ICMJE requirements. Participants will discuss practice examples, results reporting requirements, and identify helpful institutional and national resources for using the site.

Course Objectives:

  • Describe what ClinicalTrials.gov is and what it can do
  • Discuss why you should register your study (FDAAA & ICMJE)
  • Identify FDAAA required informed consent language
  • Identify who is responsible for registration (Responsible Party)
  • Discuss results reporting requirements
  • Describe how registration works at Duke
  • Identify Help Resources (institutional & national)
  • Discuss practice examples

 

 

Developing the Informed Consent | DOCR 00150391

This 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)

Register

 

 

Difficult Conversations: Tier Advancement Guide for Managers | 03026736 | Web-based offering

This 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

Register

 

Express Start - Clinical Research Specialist | 00164407 | Web-based offering

The Express Start for CRS consists of three self-paced eLearning courses 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

Register

 

Express Start - Clinical Research Coordinator | 00141671 | Web-based offering

The Express Start for CRC consists of four self-paced eLearning courses 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

Register

 

Express Start Clinical Research Nurse Coordinator | 00164563 | Web-based offering

The Express Start Onboarding Program for CRNCs consists of four self-paced e-learning courses 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

Register

 

Express Start - Regulatory Coordinator | 00145771 | Web-based offering

The Express Start for Regulatory Coordinators consists of four self-paced eLearning courses 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

Register

 

Express Start - RPM/ARPM | 00155742 | Web-based offering

The Express Start for RPM/ARPM consists of five self-paced eLearning courses 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

Register

 

Financial Basics for Clinical Research | 00155465 | Web-based offering

This 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

     Register

 

Fundamentals of Clinical Research Data Management & Collection DOCR | 00163171 | Web-based offering

The purpose of this online module is to provide an introductory overview and resources to help clinical research study teams at Duke collect and manage research data in a way that ensures data security, integrity, and provenance. Learners will be introduced to resources for planning appropriate data management and key concepts related to research data collection and database design.

Course Objectives:

  • Define the goals of proper research data management: integrity, security, provenance
  • Discuss the importance of planning for data management
  • Recognize the importance of protecting participant data
  • Identify data collection methods to address the research question
  • Describe research database design best practices to ensure data integrity and provenance
  • Find resources and tools for data management and database design

Register

 

Industry Funded Clinical Research -- Process for Contracts | DOCR-RES-260

This 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

 

 

Information Security for Research Staff | DOCR-RES-520

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

 

 

Informed Consent Process and Procedures for Clinical Research | DOCR (00150119)

This 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

Register

 

Institutional Regulatory Policies and Procedures in Clinical Research Management | DOCR-RES-441 | Web-based offering

This 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)
 

Register

 

Introduction to Submitting an IRB Application in iRIS - DOCR | DOCR-IRIS-100 | Web-based offering

This 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.

Register

 

IRB Overview | DOCR-RES-300 | Web-based offering

This class 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

Register

 

Just Ask Online: Intro to Health Equity and Diversity in Clinical Research | DOCR- 00151133 | Web-based offering

The 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

Register

 

MC Clinical Research 100 E-Learning Module | DOCR-MC-480 | Web-based Offering

This 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

Register

 

MC Clinical Research Oncology | DOCR-MC-350

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.

MC Clinical Research View Only | DOCR-MC-210 | Web-based offering

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

Register

 

OnCore Administrative Leadership Essentials - DOCR | DOCR-ONCR-160 | Web-based offering

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

Register

 

OnCore Basic Navigation - DOCR | DOCR-ONCR-110 | Web-based offering

This online course is a prerequisite for all OnCore Training courses and consists of two learning modules. 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 (both online and instructor-led).

This module covers:

  • What is OnCore?
  • Basic OnCore Navigation
  • Customizing the OnCore Dashboard
  • Consoles
  • Date Widgest & Shortcuts

Register

 

OnCore Principal Investigator Essentials - DOCR | DOCR-ONCR-180 | Web-based offering

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.

Register

 

OnCore Training for the Clinical Research Coordinator - DOCR | DOCR-ONCR-100

This instructor-lead 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.

Please complete the Web Based OnCore Training for the Clinical Research Coordinator prior to enrolling in the instructor lead course.

This module covers:

  • Subject Administration
  • Subject Calendars & Tracking
  • Reporting

 

 

OnCore Training for the Clinical Research Coordinator - DOCR | DOCR-ONCR-100 | Web-based offering

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

Register

 

OnCore Training for the Regulatory Coordinator - DOCR | DOCR-ONCR-150

This instructor-lead 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.

Please complete the Web Based OnCore Training for the Regulatory Coordinator course prior to enrolling in the instructor lead course.

This module covers:

  • Regulatory Workflows at Duke
  • Using the PC Console
  • Reporting Functions

 

 

OnCore Training for the Regulatory Coordinator - DOCR | DOCR-ONCR-150 | Wed-based offering

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

Register

 

OnCore Training: Using the SIP Console - DOCR | DOCR-ONCR-240 | Wed-based offering

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.

Register

 

Phlebotomy Competency for Research | DOCR-RES-320

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  

Phlebotomy Renewal Competency for Research | DOCR-RES-350

This competency renewal course 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 provides the renewal requirement for the Phlebotomy Competency for Research course. In order to renew this required learning, participants must:

  • Attend a Phlebotomy Competency Renewal course

Course Objectives:

  • Demonstrate phlebotomy competency on a test arm with an instructor present
  • Demonstrate knowledge of phlebotomy through successful completion of an online quiz with 80% or greater accuracy

 

 

Post Approval Submission Forms in iRIS - DOCR| DOCR-IRIS-200 | Web-based offering

This 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

Register

 

Preconsent Documentation in Maestro Care for Research – DOCR | DOCR-MC-1002 | Web-based offering (00141094)

 

This course describes the process for documenting a Preconsent status in Maestro Care for those protocols that have IRB approval for this process.

Learning Objectives:

  1. Perform the correct workflow for documenting Preconsent statuses in Maestro Care.
  2. Finding the Preconsent status on the Research Studies screen. Competencies: Electronic management of research participants' consent procedures.

Register

Readability Fundamentals for Clinical Research Participant Engagement Materials ; DOCR | Web-based offering (00160856)

This new interactive online module is now available in the LMS! This 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:

  1. Define readability and health literacy
  2. Recognize the fundamentals of readability in the context of clinical research
  3. Recognize the importance of producing materials that participants can understand
  4. 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

Register

You can also find this course on the DOCR WE-R Competency Training page under the Recruitment and Participant Retention competencies.

Reading Study Documents from a Financial Perspective - DOCR | DOCR-FIN-100

This course is intended for Duke Employees. The information presented in this course will provide strategies and practices to read Study Documents from a financial perspective to better aid in budget development and management for clinical research studies.  This course will:

  • Describe the documents to review to develop an internal cost assessment (ICA)
  • Describe types of costs associated with performing a clinical research study
  • Describe the purpose of an ICA and how it impacts budget negotiations
  • Describe CRU Management Fee
  • Describe Duke’s F&A rate

 

REDCap: Building in the Data Dictionary | DOCR-RES-560​

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). 
  

 

REDCap: Exporting/Importing and Reports | DOCR-RES-550

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.

 

REDCap: Learning To Manage Surveys | DOCR-RES-54

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

 

 

Regulatory Closeout Basics for Clinical Research | DOCR - 00150856 | Web-based offering

This 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

Register

 

Research Data Storage Plan for Staff | DOCR-RES-430

This staff training course outlines the history and purpose of the Research Data Storage Plan (RDSP). The course discusses how to fill out the Research Data Storage Plan, how to submit the plan in the iRIS system, and updating a Research Data Storage Plan that has already been approved when changes need to be made.

Course Objectives:

  • Outline the history and purpose of the Research Data Storage Plan (RDSP)
  • Complete the Research Data Storage Plan and submit the plan in the iRIS system
  • Update a Research Data Storage Plan that has already been approved when changes need to be made

 

Research Data Storage Plan: Reviewer Training | DOCR-RES-500

This is training for designated reviewers in how to review the Research Data Storage plan (RDSP).

 
 

Research Related Agreements: The Basics for Clinical Research Study Teams | 00152721

This basics 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

Register

Responsibilities of Principal Investigators Conducting Research at Duke Health - DOCR | 00151084 | Web-based offering

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

Register

Screening and Consenting Subjects | DOCR-RES-700 | Web-based offering

This training has moved! See Informed Consent Process and Procedures for Clinical Research for the new training on consenting clinical research participants.

Strategies to Support Retention of Clinical Research Participants | DOCR (00161197) | Web-based offering

This new online module is now available in the LMS! This 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

Register

You can also find this course on the DOCR WE-R Competency Training page under the Participant Retention competency.

 

Study Documentation Regulations and Best Practices | DOCR-RES-440 | Web-based offering

This 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

Register

 

Timelines, Research Ordering and Essential Linking in Maestro Care – DOCR | DOCR-MC-1003 | Web-based offering (00142358)

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

Register

Undergraduate Students Conducting the Informed Consent Process: Competency Checkoff

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

 

Updated MC Clinical Research Billing Review Process (CRC) | DOCR-MC-420 | Web-based offering

This 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

Register
 

Urine Pregnancy Screening for Research | DOCR-RES-370

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

 

Workshop: Start Building in REDCap | DOCR-RES-530

In this workshop learners will create a project using REDCap.

Course Objectives:

  • Practice building in REDCap, including application of field types, validation, and branching
  • Identify REDCap features and determine how to apply these features on a range of projects
  • Summarize the steps for moving projects to production
  • Identify best practices for collecting data

Completion of the Research Database Design Principles course is a pre-requisite for this course.