DOCR Training and Courses

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Budget Development and Negotiation Training | DOCR-RES-140

This training is required for individuals identified by their CRUs to become the “approved negotiators” of the budget and payment terms. This course reviews best practices and provides helpful tips on developing and negotiating budgets and payment terms with industry sponsors.

Course Objectives:

  • Identify which documents should be reviewed in preparing a budget
  • Identify the various costs associated with performing a study
  • Discuss Duke’s F&A rate and the differences between the CRU management charges
  • Review Duke’s preferred payment terms
  • Provide tips for negotiating with industry sponsors
  • Review recently revised Duke policies related to budgets and payment terms

 

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

Nov 6

 

Developing and Writing the Protocol | DOCR-RES-640 | Web-based offering

This module describes who can assist you in developing and writing the protocol, the contents of the protocol elements, and tips for specific types of studies.

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Developing Grant Proposals | DOCR-RES-610 | Web-based offering

This module describes reviewing the existing literature, analyzing the audience, targeting your message, writing the proposal, and submitting the proposal.

Register
 

Developing the Informed Consent Form | DOCR-RES-660 | Web-based offering

This module covers the key principles to protect human subjects, laws and guidelines, what is informed consent, when the informed consent process begins, the required elements of informed consent, the additional elements of informed consent, the one element that cannot be included, and the DUHS IRB informed consent form templates.

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Financial Basics for Clinical Research | DOCR-RES-200

Participants will gain a broad understanding of the financial concepts associated with the life cycle of a clinical research study, including understanding why an internal cost assessment is useful, how the preferred payment terms within the contract become important in the collection of monies on a study, and interpreting what a financial report may tell you about the study’s progress. The course provides an outline of the different positions, the roles that they have within clinical research, and related terminology.

Course Objectives:

  • Outline the purpose and use of an internal cost assessment, how it impacts the negotiation of the study budget, and why payment terms within a contract are important
  • Discuss the concept of revenue management, specifically how the work performed and milestones outlined in the study protocol determine earned revenue
  • Identify the type of costs incurred as the work is performed on a study and the concept of effort management
  • Outline the use and importance of financial reporting for CRU management and the principal investigator

Oct 10

 

Getting Full Institutional Approval | DOCR-RES-680 | Web-based offering

This module describes the CRU, DUHS IRB, and specialty committee reviews required to receive full institutional approval for a study at Duke. It describes the offices that are part of the review process and how to address any requested modifications.  Finally, it reviews study activities that can begin before institutional approval.

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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

Oct 8

 

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

 

 

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.

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Investigator Responsibilities | DOCR-RES-290 | Web-based offering

This course outlines basic information that principal investigators will need for their work in human subjects research at Duke. It provides information about the roles of each administrative office, avoiding research misconduct, reporting requirements, the study approval process, principles of confidentiality and privacy, and regulatory requirements for good clinical practice.

Course Objectives:

  • Distinguish between research and standard therapy and the implications of each
  • Describe requirements around effort reporting, conflict of interest reporting, and posting and publication
  • Define research misconduct and explain the investigator’s responsibility in avoiding research misconduct
  • Outline the study approval process at Duke
  • Discuss investigator responsibilities and what an investigator can and cannot delegate to qualified study personnel
  • Outline HIPAA components and how they relate to sensitive electronic information
  • Summarize the IRB scope of responsibilities and authority
  • Explain the key regulatory requirements and good clinical practices that apply in the protection of human subjects during the informed consent process and the investigator’s responsibilities during the consent process
  • Apply the applicable regulations in the investigator’s role of identification, documentation, reporting, and determining causality of adverse events and unanticipated problems

Register

 

The IRB and Submitting the Study to the IRB | DOCR-RES-670 | Web-based offering

This module describes the regulations that govern IRBs, who serves on the IRB, the IRB and Institutional review process at Duke, how much DUHS oversight is required for certain types of studies, how to submit the study using the eIRB system, when the IRB reviews the study, what the IRB reviews, and the possible outcomes of the IRB review.

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IRB Overview | DOCR-RES-300

This 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 web site; presents an example of an eIRB submission; 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
  • Describe the IRB review process
  • Outline a basic overview of the eIRB system, including how to gain access to eIRB, how to use and navigate within eIRB, how to find out study status, and how to get help with eIRB
  • Describe reporting to the IRB
  • Describe how to communicate with the IRB and make use of the many tools available on the IRB website

Sep 24   Oct 22   Nov 19   Dec 17

 

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

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Monitoring and Reporting Safety | DOCR-RES-710 | Web-based offering

This module defines adverse event and serious adverse events. It provides specific guidance for documenting an event correctly. This module provides regulatory guidance for determining if an event is reportable under 45 CFR Part 46. In addition, it discvusses what, when, and how to report events to the FDA, sponsor, funding agency, ClinicalTrials.gov, and the DUHS IRB.

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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.

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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

Sep 24   Oct 22   Nov 5   Dec 10

 

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

Sep 17   Oct 15   Nov 12   Dec 3 

 

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.

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Overview of Clinical Research at Duke | DOCR-RES-600 | Web-based offering

This module describes the drug or device development process, defines human subject research, explains why the entire clinical research community is interested in protecting human subjects, describes the patient’s experience, describes the study team and it’s oversight at Duke, describes the groups that enable and support clinical research at Duke, describes the progression of a Duke clinical study, and discusses protecting intellectual property.

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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

 

 

Planning for Data Collection | DOCR-RES-650 | Web-based offering

This module describes how data can be shared, who is involved in the process, who owns the data, who can sign an agreement, why the data are collected, what data are needed, defining the data elements and creating the data dictionary, when data will be collected, how data will be collected, where data will be stored, documenting the data plan, building and testing the database, and defining the data collection process.

Register
 

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

 

Preparing the Study Specific Documentation | DOCR-RES-690 | Web-based offering

This module describes the study-level documentation expected at Duke. It describes the regulatory binder, documents required for all studies, documents required for most studies, and documents that are required depending on the type of study. It discusses standard operating procedures. This module provides guidance for creating the binder or file, maintaining central files, and what should not be included in the documentation to be audit ready.

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Querying Analyzing and Closing Out the Data | DOCR-RES-730 | Web-based offering

This module provides guidance to prepare records for storage and retention. It discusses the query process, recognizing trends in data and queries, working with statisticians to analyze the data, and types of data sets. It provides guidance for de-identifying data and transferring data. It discusses locking and freezing the database.

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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​

Oct 18

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

Sep 20   Dec 20

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

Nov 15

Reporting Problems and Maintaining IRB Approval | DOCR-RES-720 | Web-based offering

This module defines the type of problems that must be reported to the IRB, how to report the problem, and the consequences of improper reporting. It discusses maintaining the key personnel list for a study. This module provides guidance for maintaining IRB approval and the continuing review process. It discusses handling amendments to the protocol and maintaining ClinicalTrials.gov study status.

Register
 

Research Data Integrity and Data Security | DOCR-RES-330 | Web-based offering

This course designed for staff members presents the basic principles of data management and how these principles contribute to data security. The course also addresses key concerns in data security and how to manage these issues.

Course Objectives:

  • Define data provenance and outline its importance to scientific research
  • Describe basic principles of data management and how use of these principles contribute to data integrity and data security
  • Outline key terms used in data management, including PHI, SEI, types of data sets (full, limited, de-identified, anonymous)
  • Describe key concerns in data security, including use of email, databases, VA data, Social Security Numbers, cloud storage, and other external devices and how to address these concerns

Register

 

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

This staff training course outlines the history and purpose of the Research Data Security Plan (RDSP). The course discusses how to fill out the Research Data Security Plan, how to submit the plan in section 12.1 of the eIRB system, and updating a Research Data Security Plan that has already been approved when changes need to be made.

Course Objectives:

  • Outline the history and purpose of the Research Data Security Plan (RDSP)
  • Complete the Research Data Security Plan and submit the plan in section 12.1 of the eIRB system
  • Update a Research Data Security Plan that has already been approved when changes need to be made

Nov 11

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

 

Research Database Design Principles | DOCR-RES-410

This course will help the participant identify the research question and summarize approaches for answering the research question. The learner will be able to define data collection methodology, describe and compare database design best practices, and discuss tips and tricks for designing databases for research purposes.

Course Objectives:

  • Identify the research question and summarize approaches for answering the research question
  • Define data collection methodology
  • Describe and compare database design best practices
  • Discuss tips and tricks for designing databases for research purposes

Oct 4   Nov 1   Dec 6

 

Reviewing the Literature and Determining the Research Question | DOCR-RES-630 | Web-based offering

This module describes reviewing the existing literature, and developing the research question and research hypothesis.

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

This module describes how to determine the informed consent process for your specific study. It describes the consenting plan and consent form revisions. It provides specific regulatory guidance for who can provide consent for a subject to participate in a study including discussing assent, vulnerable populations, and the legally authorized representative. This module provides guidance for how to discuss the study and assess the potential subject to obtain consent and how to document informed consent. Finally, it discusses when the subject must re-consent and the screening process.

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Study Design and Statistical Considerations | DOCR-RES-620 | Web-based offering

This module discusses population and sample size, the purpose and types of variables, subject assignment and controls, study types and treatment sequences, complex study types, reliability and validity, and collaboration with Duke experts.

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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

 

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 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 the DOCR Training Team (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

Oct 17   Nov 7   Dec 3
 

 

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.

Sep 13   Oct 11   Nov 8   Dec 13