Competency Training

Competency domains of clinical research used at Duke with the competencies listed inside the graphic

Competency Training:

This is a list of course offerings that have been mapped to the Duke WE-R competencies. A full listing of the competencies and associated assessments can be found on the WE-R Tier Advancement page.

Until further notice, all DOCR instructor-led classes will be offered via WebEx 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 call-in information.  Questions should be directed to docr.help@dm.duke.edu

Research Operations training banner

Contracts and Agreements

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


Industry Funded Clinical Research - Process for Contracts |  In-person

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

Register


Reading Study Documents from a Financial Perspective - DOCR | In-person

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

Register

 

FDA Regulatory Submissions

Investigational New Drug Sponsor and Investigator Responsibilities | 00122655 | Web-based offering

This training will cover the responsibilities associated with maintaining an IND and is intended for academic investigators who will hold an IND. This training consists of ten modules. The first nine modules will cover IND sponsor responsibilities that must be fulfilled by investigators who conduct a clinical investigation run under an IND. Investigators fulfilling a dual role as sponsor and investigator, in other words, sponsor-investigators, must fulfill the responsibilities of both sponsors and investigators.

The Modules include:

  • Introduction to IND Sponsors and Investigator Responsibilities
  • Overview of IND Maintenance and Tracking
  • IND Annual Reports
  • IND Safety Reporting
  • IND Information and Amendments
  • Maintaining Accountability Records for INDs
  • IND Protocol Amendments
  • IND Monitoring and Multi-Center Trails
  • Financial Disclosure
  • IND Investigator Responsibilities

Register


Investigational Device Exemption Sponsor and Investigator Responsibilities | 00122655 | Web-based offering

This training will cover the responsibilities associated with maintaining an IDE and is intended for academic investigators who will hold that IDE for a significant risk device study. This training consists of ten modules. The first nine modules will cover IDE sponsor responsibilities and the final module will cover responsibilities that must be fulfilled by investigators who conduct a significant risk device study run under an IDE. Investigators fulfilling a dual role as sponsor and investigator, in other words, sponsor-investigators, must fulfill the responsibilities of both sponsors and investigators.

The Modules include:

  • Introduction to IDE Sponsor and Investigator Responsibilities
  • Overview of IDE Maintenance and Tracking
  • IDE Progress Reports and Final Reports
  • IDE Modifications
  • Unanticipated Adverse Device Effects
  • IDE Reports
  • Maintaining Accountability Records for IDEs
  • IDE Monitoring and Multi-Center Trails
  • Financial Disclosure
  • IDE Investigator Responsibilities

Register


Regulating Medical Products: FDA Oversight of Drugs and Devices | 00151992 | Web-based offering

This course provides an overview of how the FDA regulates drugs and medical devices that are tested using clinical trials.

Register


Office of Regulatory Affairs and Quality 

Regulatory Affairs Training Program


CITI Training

  • ICH - Comparison Between ICH GCP E6 and U.S. FDA Regulations
  • The CITI Good Clinical Practice Course for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
  • Investigator Obligations in FDA-Regulated Research
  • Overview of U.S. FDA Regulations for Medical Devices

Institutional Regulatory Policies and Processes

Institutional Regulatory Policies and Procedures in Clinical Research Management - DOCR | 00139987 | 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

Register


IRB Overview - DOCR-RES-300 | Web-Based Offering

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

  Register 


ClinicalTrials.gov Registration and Results Submission Overview  |  In-person

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

Register


Navigating Clinical Research at Duke: What You Need to Know - DOCR  | 00141224 | Web-based offering

This course is part of the Express Start onboarding collection. It will provide the general organizational structure of Duke, central support offices, and an overview of a Clinical Research Unit (CRU) and Oversight Organization (OO).

Register


Prompt Reporting to the IRB WBT - DOCR  | 00145900 | Web-based offering

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.

Course Objectives:

  • Recognize what constitutes a protocol deviation, violation, adverse event, and unanticipated problem
  • Recognize what events need to be reported to the IRB
  • Identify FDAAA required informed consent language
  • IRecall 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.

Register

International Regulatory Documentation

Study Documentation Regulations and Best Practices - DOCR | 00137344 | 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

Investigational Products

Regulating Medical Products: FDA Oversight of Drugs and Devices | 00151992 | Web-based offering

This course provides an overview of how the FDA regulates drugs and medical devices that are tested using clinical trials.

Register


CITI Training

  • Overview of New Drug Development
  • Conducting Investigator-Initiated Studies According to FDA Regulations and GCP
  • The CITI Good Clinical Practice Course for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
  • Managing Investigational Agents According to GCP Requirements
  • Overview of U.S. FDA Regulations for Medical Devices

Investigational Products (Provided by the Society of Clinical Research Sites)

Overview of the basics of Investigational Product management and use during a clinical trial. Topics include inventory and temperature control and recommendations for source documentation.

Society for Clinical Research Sites Online Training

Monitoring and Audits

CITI Training

  • Monitoring of Clinical Trials by Industry Sponsors
  • Audits and Inspections of Clinical Trials

Monitoring and Auditing (Provided by the Society of Clinical Research Sites)

Describes the routine monitoring and auditing activities that occur during a clinical study. This topic includes information on the purpose, what to expect, and tips to prepare for these Sponsor activities.

Society for Clinical Research Sites Online Training

Participant Level Documentation

Study Documentation Refresher Series 3: Participant Level Documentation | 00145567 | Web-based offering

This 15 to 20 minute module discusses what documents are “participant level” along with some specifics around informed consent, research data, and source data documentation. You’ll also learn how case report forms are used to report research data to the sponsor.

Register


Study Documentation Regulations and Best Practices - DOCR | 00137344 | 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


OnCore Training for the Clinical Research Coordinator - DOCR | 00110056 | 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 | 00114396 | 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


MC Clinical Research 100 E-Learning Module | 00129623 | 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


Essential Documents for a Clinical Study (Provided by the Society of Clinical Research Sites)

Describes the requirements for Clinical Study essential documents. Describes the type of essential documents collected for a Clinical Study during the different study phases.

Source Documentation (Provided by the Society of Clinical Research Sites)

A review of the terms source data and source documents. Describes the key attributes of source documents, the intent of ALCOA and CCEA and describes the appropriate processes for creating, maintaining and storing source documents.

Society for Clinical Research Sites Online Training

Participant Retention

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 health equity and diversity lens into study plans.

  • Define health disparities
  • Differentiate between health equity and equality
  • Recognize the 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


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

Register


Recruitment Innovation Center through CTSI | On-demand

Plain Language Mini-Consults: Our plain language mini-consult will provide you with a lay-summary of your research, bulleted statements and taglines that you can use in your advertising materials and a lay-friendly concise summary of your project that you can use in your informed consent form.


Engagement, Recruitment, and Retention Certificate Program | Set Schedule (Nomination Required) - Click for webpage

The Clinical and Translational Science Institute’s Recruitment Innovation Center has collaborated with DOCR to gather a team of experts across Duke and beyond to create a certificate program focused on engaging, recruiting, and retaining clinical research participants that is free to Duke research staff. Program Goals

  • Develop a cohort of engagement, recruitment, and retention specialists who can serve as a resource for their clinical research units, departments, and divisions.
  • Bolster the skills that are necessary for both meaningful and inclusive engagement, recruitment, and retention engagement practices.
  • Help study teams think critically about participant engagement and recruitment and participant engagement from perspectives other than their own.

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 the 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.

Learning Objectives:

  1. Define participant retention
  2. Describe strategies for retention and their importance
  3. Identify ways to set clear study expectations to support retention
  4. Discuss the importance of study continuation with participants

Register


Recruitment

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


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

Register


Recruitment and Engagement Policy Training -DOCR | 00135223 | Web-based offering

The Duke University Health System (DUHS) has revised language in the Notice of Privacy Practices (NPP) Brochure. To align with the revised NPP, the Recruitment and Engagement Policy will allow study teams to engage patients through contacts including, but not limited to portal messages, mobile health devices, telephone, electronic surveys at clinic visits or hospital admissions, or directly via one or more clinicians. Any of these methods may be used to engage patients in research related to their health, if approved by the DUHS Institutional Review Board (IRB). Training on the new policy is required prior to IRB approving updated recruitment plans utilizing expanded recruitment options.

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 health equity and diversity lens into study plans.

  • Define health disparities
  • Differentiate between health equity and equality
  • Recognize the 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


OnCore Training: Using the SIP Console - DOCR | 00129901 | 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


Engagement, Recruitment, and Retention Certificate Program | Set Schedule - Click for webpage

The Clinical and Translational Science Institute’s Recruitment Innovation Center has collaborated with DOCR to gather a team of experts across Duke and beyond to create a certificate program focused on engaging, recruiting, and retaining clinical research participants that is free to Duke research staff. Program Goals

  • Develop a cohort of engagement, recruitment, and retention specialists who can serve as a resource for their clinical research units, departments, and divisions.
  • Bolster the skills that are necessary for both meaningful and inclusive engagement, recruitment, and retention engagement practices.
  • Help study teams think critically about participant engagement and recruitment and participant engagement from perspectives other than their own.

Conducting a Study (Provided by the Society of Clinical Research Sites)

Explains the three stages of study conduct phases including the subject enrollment/recruitment period, the ongoing maintenance and the subject exit/completion phase including the tasks and activities associated with these stages.

Society for Clinical Research Sites Online Training

Screening

Conducting a Study - Provided by the Society of Clinical Research Sites

Explains the three stages of study conduct phases including the subject enrollment/recruitment period, the ongoing maintenance and the subject exit/completion phase including the tasks and activities associated with these stages.

Society of Clinical Research Sites

SOPs

Specimen Management

Phlebotomy Competency for Research | DOCR-RES-320 |  In-person

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.

Phlebotomy Competency Training for Research Study Personnel (03/06/2020) - This policy defines the training requirements and skills necessary to perform venipuncture/phlebotomy for the purposes of research in Duke Medicine.

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

View Dates and Register  


Phlebotomy Renewal Competency for Research | DOCR-RES-350 |  In-person

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.

Phlebotomy Competency Training for Research Study Personnel (03/06/2020) - This policy defines the training requirements and skills necessary to perform venipuncture/phlebotomy for the purposes of research in Duke Medicine.

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

Urine Pregnancy Screening for Research | DOCR-RES-370  |  In-person

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.

Urine Testing for Pregnancy Screening to Determine Eligibility to Participate in Research Studies (11/11/2018)

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

View Dates and Register


OESO Training: click here for website

  • Bloodborne Pathogens Training
  • Biosafety Level 2 and BBP for Lab Workers
  • Shipping Biological Materials
  • Chemical Safety-Orientation
  • Chemical Safety-Update
  • Laboratory Safety General

Study Level Documentation

Study Documentation Regulations and Best Practices - DOCR | 00137344 | 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


Study Documentation Refresher Series 2: Study Level Documentation | 00145562 | Web-based offering

This 20 to 25 minute module discusses what study level documentation is, how to maintain it, and resources for creating and maintaining a compliant regulatory binder. You’ll also learn what documents are required for different types of studies and the importance of SOPs.

Register


Study Documentation Refresher Series 4: How To’s and Best Practices | 00145568 | Web-based offering

This 10 to 15 minute module discussed best practices for maintaining study documentation, proper practices for notation of changes, and when a note/memo to file might be required. You’ll also hear about when a protocol deviation would require both a Note/Memo to File and reporting to the IRB.

Register


Post Approval Submission Forms in iRIS - DOCR| 00121335 | 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


eReg Training for the Regulatory Coordinator

This course provides Regulatory Coordinators the information and knowledge needed to utilize the Forte eRegulatory Management System (eReg). eReg is an electronic regulatory binder maintenance system used to collect and manage protocol, staff, and institution documentation.

Register


Essential Documents for a Clinical Study (Provided by the Society of Clinical Research Sites)

Describes the requirements for Clinical Study essential documents. Describes the type of essential documents collected for a Clinical Study during the different study phases.

Source Documentation (Provided by the Society of Clinical Research Sites)

A review of the terms source data and source documents. Describes the key attributes of source documents, the intent of ALCOA and CCEA and describes the appropriate processes for creating, maintaining and storing source documents.

Delegation and Training (Provided by the Society of Clinical Research Sites)

An overview of study task delegation and the importance of providing/documents study training for site staff.

Society for Clinical Research Sites Online Training

Study Visits

Conducting a Study - Provided by the Society of Clinical Research Sites

Explains the three stages of study conduct phases including the subject enrollment/recruitment period, the ongoing maintenance and the subject exit/completion phase including the tasks and activities associated with these stages.

Society of Clinical Research Sites


Subject Visit Tracking in OnCore | 00147730

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.

Register


Timeline, Research Ordering, and Essential Linking in Maestro Care

This course reviews workflows for adding timelines, research associating orders and linking appointments & encounters in Maestro Care.

This module covers:

Register


OnCore Training: PC Console Overview for OnCore Financials -DOCR | 00120785 | Web-based offering

This course is required to be completed as a prerequisite before attending the instructor-lead OnCore Financial Training classes. By the end of this course you will have an introductory understanding of the PC Console for OnCore Financials.

Register


OnCore Training for the Clinical Research Coordinator - DOCR | 00110056 | 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 | 00114396 | 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


Getting Started with Your Clinical Research Portfolio - DOCR | 00141253 | Web-based offering

This course is part of the Express Start onboarding collection. It will provide tips and tricks for becoming familiar with your clinical research portfolio. This course will also provide tools and resources to help you get started participating in the management of your clinical research studies.

Register

Team Meetings

Safety and Ethics training banner

Adverse Events

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


Post Approval Submission Forms in iRIS - DOCR| 00121335 | 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


Prompt Reporting to the IRB WBT - DOCR  | 00145900 | Web-based offering

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.

Course Objectives:

  • Recognize what constitutes a protocol deviation, violation, adverse event, and unanticipated problem
  • Recognize what events need to be reported to the IRB
  • Identify FDAAA required informed consent language
  • IRecall 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.

Register


CITI Training

  • Detecting and Evaluating Adverse Events
  • Reporting Serious Adverse Events

Adverse Events and Safety (Provided by the Society of Clinical Research Sites)

Explains and defines an Adverse Event. Describes the Investigator’s role and responsibilities regarding Subject Safety and reporting requirements for Serious Adverse Events.

Society for Clinical Research Sites Online Training

Consent Procedures

Informed Consent Process and Procedures for Clinical Research | 00150119| Web-based Offering

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.

Learning 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


MC Clinical Research 100 E-Learning Module | 00129623 | 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


Informed Consent: Remote Consenting - DOCR | 00147618 | Web-based Offering

This course is intended for study team members at Duke who may consent participants to clinical research studies remotely. Remote means the consent process is not occurring in-person.

Register


CITI Training

  • Informed Consent in Clinical Trials of Drugs, Biologics, and Devices

Clinical Practice vs. Clinical Research (Provided by the Society of Clinical Research Sites)

An overview of the differences between the activities which occur when managing patients during routine Clinical Practice versus the activities when you are managing subjects as part of a Clinical Research Study.

IRB/IEC Responsibilities and Informed Consent (Provided by the Society of Clinical Research Sites)

Overview of the purpose and activities of the IRB/IEC and the Investigator’s responsibilities in accordance with ICH-GCP. Describes the process of informed consent and the responsibilities of the Investigator when obtaining informed consent.

Society for Clinical Research Sites Online Training

Development of the Informed Consent Documentation and Plan

Developing the Informed Consent Form | DOCR 00150391 | Web-based Offering

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


CITI Training

  • Informed Consent in Clinical Trials of Drugs, Biologics, and Devices

Clinical Practice vs Clinical Research (Provided by the Society of Clinical Research Sites)

An overview of the differences between the activities which occur when managing patients during routine Clinical Practice versus the activities when you are managing subjects as part of a Clinical Research Study.

Society of Clinical Research Sites

Navigating the Ethics Review Process (IRB)

IRB Overview - DOCR-RES-300 | Web-Based Offering

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

  Register 


Introduction to Submitting an IRB Application in iRIS - DOCR | 00133297 | 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


Post Approval Submission Forms in iRIS - DOCR| 00121335 | 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


Research Ethics in the Context of Clinical Research - FORCE | 00152210 | Web-based offering

This course explains the basics of ethical principles in clinical research and the unethical history that transformed the way clinical research was conducted. This presentation has three objectives:(1) Recognize why it is important to adhere to ethical principles while conducting clinical research (2) Describe historical unethical research studies that led to the establishment of ethical guidelines and regulations governing clinical research (3) Describe the main ethics principles in the context of human subjects research

Register


CITI Training

  • Vulnerable Subjects - Research Involving Prisoners
  • Vulnerable Subjects - Research Involving Children
  • Vulnerable Subjects - Research Involving Pregnant Women, Fetuses, and Neonates

IRB/IEC Responsibilities and Informed Consent (Provided by the Society of Clinical Research Sites)

Overview of the purpose and activities of the IRB/IEC and the Investigator’s responsibilities in accordance with ICH-GCP. Describes the process of informed consent and the responsibilities of the Investigator when obtaining informed consent.

Society for Clinical Research Sites Online Training

Sponsor/Regulatory Reporting

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

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

Study Documentation Regulations and Best Practices - DOCR | 00137344 | 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


Study Documentation Refresher Series 1: Introduction to Clinical Research Documentation | 00145375 | Web-based offering

This 12 to 15 minute module discusses the importance of study documentation and how to navigate different governing authorities as it relates to study documentation.

Register


Prompt Reporting to the IRB WBT - DOCR  | 00145900 | Web-based offering

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.

Course Objectives:

  • Recognize what constitutes a protocol deviation, violation, adverse event, and unanticipated problem
  • Recognize what events need to be reported to the IRB
  • Identify FDAAA required informed consent language
  • IRecall 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.

Register


Investigational New Drug Sponsor and Investigator Responsibilities | 00122655 | Web-based offering

This training will cover the responsibilities associated with maintaining an IND and is intended for academic investigators who will hold an IND. This training consists of ten modules. The first nine modules will cover IND sponsor responsibilities that must be fulfilled by investigators who conduct a clinical investigation run under an IND. Investigators fulfilling a dual role as sponsor and investigator, in other words, sponsor-investigators, must fulfill the responsibilities of both sponsors and investigators.

The Modules include:

  • Introduction to IND Sponsors and Investigator Responsibilities
  • Overview of IND Maintenance and Tracking
  • IND Annual Reports
  • IND Safety Reporting
  • IND Information and Amendments
  • Maintaining Accountability Records for INDs
  • IND Protocol Amendments
  • IND Monitoring and Multi-Center Trails
  • Financial Disclosure
  • IND Investigator Responsibilities

Register


Investigational Device Exemption Sponsor and Investigator Responsibilities | 00122655 | Web-based offering

This training will cover the responsibilities associated with maintaining an IDE and is intended for academic investigators who will hold that IDE for a significant risk device study. This training consists of ten modules. The first nine modules will cover IDE sponsor responsibilities and the final module will cover responsibilities that must be fulfilled by investigators who conduct a significant risk device study run under an IDE. Investigators fulfilling a dual role as sponsor and investigator, in other words, sponsor-investigators, must fulfill the responsibilities of both sponsors and investigators.

The Modules include:

  • Introduction to IDE Sponsor and Investigator Responsibilities
  • Overview of IDE Maintenance and Tracking
  • IDE Progress Reports and Final Reports
  • IDE Modifications
  • Unanticipated Adverse Device Effects
  • IDE Reports
  • Maintaining Accountability Records for IDEs
  • IDE Monitoring and Multi-Center Trails
  • Financial Disclosure
  • IDE Investigator Responsibilities

Register

Data training banner

Data Collection and Entry

Research Database Design Principles | DOCR-RES-410 | In-Person

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

May 1   Jun 5


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

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.

May 8   Jun 12


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

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

 May 15


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

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 | In-Person

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.

Jun 19


Research Data Integrity and Data Security | 00041662 | 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

 

Data Quality Assurance

Research Data Integrity and Data Security | 00041662 | 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


CITI Training

  • Reproducibility of Research Results

OESO Training 

Data Security and Provenance

Information Security for Research Staff | DOCR-RES-520 | In-person

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

View Dates and Register


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

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, 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 
  • Update a Research Data Storage Plan that has already been approved when changes need to be made

View Dates and Register


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

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

View Dates and Register


Research Data Integrity and Data Security | 00041662 | 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

OESO Training 

Mapping Data Flow

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.

View Dates and Register


CITI Training

  • Data Management (RCR Basic)

Technology Use and Innovation

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

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). 

View Dates and Register


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

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.

View Dates and Register


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


Research Data Integrity and Data Security | 00041662 | 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

 

Scientific Concepts training banner

Funding Proposal Development

Budget and Payment Terms Basics for Industry-Sponsored Clinical Trials | 00152966

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


Introductory Overview of Sponsored Research - DOCR/OPSD | 00146886

This course will provide individuals engaged in clinical and biomedical research with an introductory overview of sponsored research. Those interested in learning more about sponsored research in preparation for identifying a research strategy and funding opportunities within their research discipline should check it out. This course was created in collaboration between DOCR and the Office of Physician Scientist Development for the Pediatric Scientist Development Program.

Register


Getting Started with Research Funding - DOCR/OPSD | 00146887

This course will provide individuals engaged in clinical and biomedical research with introductory information about federal, and non-federal, research funding resources and tips for navigating research funding opportunities that align with their research objectives.This course was created in collaboration between DOCR and the Office of Physician Scientist Development for the Pediatric Scientist Development Program.

Register


Early Career Funding Opportunities Overview - DOCR/OPSD | 00146888

This course will provide guidance on NIH sponsored Training, Fellowship, and Career Development award programs. Including discussion on how these programs relate to a larger picture of career progression. While this course will mainly focus on the NIH; the NSF, DOD, and foundations are also covered lightly. This course was created in collaboration between DOCR and the Office of Physician Scientist Development for the Pediatric Scientist Development Program.

Register


Financial Basics for Clinical Research - DOCR | 00140600 

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

Register


Reading Study Documents from a Financial Perspective - DOCR | 00140603| In-Person

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

 

Literature Reviews

Protocol Development

Introduction to Submitting an IRB Application in iRIS - DOCR | 00133297 | 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


Post Approval Submission Forms in iRIS - DOCR| 00121335 | 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


Clinical Research Overview - Web-based - Provided by the Society of Clinical Research Sites

Introduces and describes the phases of a Clinical Research Study and the various study designs.

Society for Research Clinical Sites Training

Research Design

Research Database Design Principles | DOCR-RES-410 | In Person

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

Biostatistics, Epidemiology, and Research Design (BERD) Methods Core: Intro to Clinical Research Design

Topics: Intro to Research and Design, Formulating the Research Question, The Null and Alternative Hypothesis, Study Design and Data Collection


CITI Training

  • Intro to RCR

Clinical Research Overview (Provided by the Society of Clinical Research Sites)

Introduces and describes the phases of a Clinical Research Study and the various study designs.

Society for Clinical Research Sites Online Training

Conducting a Study - Web-based - Provided by the Society of Clinical Research Sites

Explains the three stages of study conduct phases including the subject enrollment/recruitment period, the ongoing maintenance and the subject exit/completion phase including the tasks and activities associated with these stages.

Society for Research Clinical Sites Training

Scholarly Works

CITI Training

  • Reproducibility of Research Results

Site and Study Management training banner

Coordination with Sponsor/CRO

Monitoring and Auditing (Provided by the Society of Clinical Research Sites)

Describes the routine monitoring and auditing activities that occur during a clinical study. This topic includes information on the purpose, what to expect, and tips to prepare for these Sponsor activities.

Society for Clinical Research Sites Online Training

Electronic Management of Research Participants and Protocols

MC Clinical Research 100 E-Learning Module | 00129623 | 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


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
 


OnCore Basic Navigation - DOCR | 00108165 | 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 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 | 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 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


Express Start Onboarding Program-CRC | 00141671 | Web-based offering

The Express Start Onboarding Program 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 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 Onboarding Program-Regulatory Coordinator | 00145771 | Web-based offering

The Express Start Onboarding Program 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 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

 

Electronic Management of Research Protocols

Feasibility

Managing Resources

Managing Risk

Study Documentation Regulations and Best Practices - DOCR | 00137344 | 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


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


CITI Training

  • Conflicts of Interest
  • Research Misconduct (RCR Basic)

Operational Plans

Study Closeout

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


Study Documentation Refresher Series 5: Document Retention | 00145569 | Web-Based Offering

This 10 to 15 minute module discusses how documents are retained and stored for open and closed studies as well as how regulations inform document retention requirements. You’ll also learn tips on planning for document storage and retention.

Register