RAA Industry Pre-Award Learning Track | Research Compliance & Reporting

Phase 1: Onboarding

Part A: Duke Way Courses	Part B: Systems Training
Duke Way: Account & Financial Basics Duke Way: Research Administration Systems Duke Way: Professionalism	Introduction to SPS OnCore: Basic Navigation

Phase 2: In-depth Courses

PArt A: e-Learning	Part B: Virtual Classroom Sessions
Budget & Payment Terms Basics for Industry-Sponsored Clinical Trials Financial Basics for Clinical Research Industry Funded Clinical Research: Process for Contracts Institutional Regulatory Policies & Procedures in Clinical Research Management Research Related Agreements: Basics for Clinical Research Study Teams	Communication is Key Intro to Regulatory Compliance Navigating Sponsor Documents Research Administration Fundamentals

Part 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

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.

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

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

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)

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

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

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

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

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

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