RAA Industry Pre-Award Learning Track

Phase 1: Onboarding 

Phase 2: In-depth Courses

Phase 1 Course Details

Phase A: Duke Way Online Modules

Duke Way: Accounting & Financial Basics @ Duke

• Understand and define basic accounting terms and key principles
• Demonstrate the role of accounting in research administration
• Identify the financial responsibility structure at Duke
• Recognize the accounting tools and processes used in research administration at Duke
• Interpret the hierarchy of designations used by Duke in SAP
• Understand how features of research administration are translated to SAP

Duke Way: Research Administration Systems @ Duke

• Explore the role of systems in research administration processes
• Identify key systems used in research administration at Duke 
• Explain the functions of research administration systems 
• Identify system owners, offices, and resources that support research administration systems

Duke Way: Professionalism in Research Administration @ Duke

• Recognize the major components of professionalism in research administration
• Understand the role that professionalism plays in research administration at Duke
• Identify strategies and techniques to demonstrate professionalism

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Part B: Systems Training

Introduction to SPS

This is an introduction to Duke's pre-award system, SPS, and is open to Campus and SOM/N. Participants will discuss important pre-award concepts related to SPS entry and will practice entering information into SPS.

OnCore: Basic Navigation

The purpose of this online module is to provide clinical research personnel with the foundational information needed to get started navigating the OnCore system. This module covers the OnCore system interface, functional roles in OnCore, console navigation, and tips when using the system.

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Phase 2 Course Details

Part A: e-Learning

These courses can be completed at the same time as the 2B Virtual Classroom Sessions.

Budget & Payment Terms Basics for Industry-Sponsored Clinical Trials

• 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

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Financial Basics for Clinical Research

• Describe clinical research from a financial perspective
• Describe the types of costs associated with a clinical trial/research study
• Describe the concept of effort management
• Describe financial and management reporting
• Describe financial close-out requirements
• Describe systems useful in following financial activities associated with a clinical trial/research study

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Industry Funded Clinical Research: Process for Contracts

• 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
• Understand the basic responsibilities of the Duke Office of Research Contracts (ORC)

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Institutional Regulatory Policies & Procedures in Clinical Research Management

• 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

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Research Related Agreements: Basics for Clinical Research Study Teams

• Identify typical agreements/contracts (MTAs, CTAs, CDAs, DTAs)
• Recognize when typical agreements are necessary
• Identify offices responsible for different types of agreements
• Describe processes for putting agreements in place
• Identify special considerations and tips when establishing an agreement

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Part B: Virtual Classroom Sessions

These courses can be completed at the same time as the 2A e-Learning Classes.

Communication is Key

Suggested Order

None

Learning Objectives

• Describe why communication is important to research administration
• Compare and contrast communication modes and methods
• Choose effective communication strategies for your audience
• Recognize your strengths and weaknesses in communication
• Identify ways to communicate more effectively
• Identify aspects of clear and concise written communications
• Develop a team environment to enhance collaboration
• Prepare for difficult conversations

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Intro to Regulatory Compliance

Suggested Order

None

Learning Objectives

• Identify the regulated activities and materials frequently associated with research
• Obtain a general familiarity with the general concepts and processes governing regulated activities in research
• Recognize the role of research administrators in regard to research subjects, regulated substances, conflict of interest, and export control
• Understand where to find expertise on these topics to obtain accurate guidance and ensure compliance 

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Navigating Sponsor Documents

Suggested Order

None

Learning Objectives

• Gain universal skills to navigate documents & communications
• Identify the goal and purpose of written content 
• Establish how to present that information to others 
• Explore the different methods to engage with complex content
• Learn helpful annotation and reading tips for improved efficiency
• Explore working with sponsor guidance documents and other types of written information

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Research Administration Fundamentals of Industry-Sponsored Research

Suggested Order

None

Learning Objectives

• Properly classifying individuals as employees or independent contractors
• Describing the importance of GL accounts
• Differentiating the different methods of procuring goods and services
• Identifying the appropriate use and operational procedures associated with different procurement methods
• Explaining the role of Grant Managers in the procurement process
• Recognizing situations that may be concerning to auditors

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