Clinical Research Coordinator (CRC)

• Describe the roles and responsibilities of a Clinical Research Coordinator (CRC)
• Identify the clinical research offices and resources within LSU Health New Orleans
• Identify the clinical research systems used at LSU Health New Orleans and understand how they interact with one another
• Discuss the studies that make up your research portfolio
• Describe the career progression within clinical research professionals

Clinical Research Coordinator (CRC) Foundations

Offered by CITI

• The CRC Foundations course provides clinical research professionals with basic training tailored to the CRC’s fundamental role in the conduct of clinical trials. It is designed for new CRCs and can be used by organizations as onboarding training. It may also be useful to those pursuing a career in clinical research.

Clinical Research Coordinator (CRC) Advanced

Offered by CITI

• The CRC Advanced course provides clinical research professionals with advanced training tailored to the CRC’s critical role in the conduct of clinical trials. It is designed for CRCs who have taken CRC Foundations, or those with two or more years of experience as a CRC. It complements the foundational course, and may be used for professional development and/or as a refresher course.

Clinical Research Nurse Coordinator (CRNC)

• Describe the roles and responsibilities of a Clinical Research Nurse Coordinator (CRNC)
• Identify the clinical research offices and resources within LSU Health New Orleans
• Identify the clinical research systems used at LSU Health New Orleans and understand how they interact with one another
• Discuss the studies that make up your research portfolio
• Describe the career progression within clinical research professionals
• Define nursing responsibilities, competencies, and credentialing for the CRNC role

Regulatory Coordinator (RC)

• Describe the roles and responsibilities of a Clinical Research Coordinator (CRC)
• Identify the clinical research offices and resources within LSU Health New Orleans
• Identify the clinical research systems used at LSU Health New Orleans and understand how they interact with one another
• Discuss how to find and follow applicable standards, guidelines, regulations, policies, and procedures for performing clinical research at LSU Health New Orleans
• Describe the career progression within clinical research professionals

Research Ethics in the Context of Clinical Research

• Describe historical unethical research studies that led to the establishment of ethical guidelines and regulations governing clinical research
• Describe the main ethics principles in the context of human subject research
• Describe the differences between FDA vs. HHS vs. ICH Guidelines, and when each guideline is applicable

Institutional Review Board (IRB) Overview                             

• Describe the IRB’s scope of oversight – what does and what does not require review by the IRB
• Describe the IRB review process
• Outline a basic overview of the system, including how to gain access to the system, how to use and navigate within the system, how to find out study status, and how to get help with the system
• Describe how to communicate with the IRB and make use of the many tools available on the IRB website

Submitting an IRB Application (Live Walk-Through)

• The live demonstration will describe the workflow among the main research workflow system Kuali and will introduce users to the Kuali system, basic navigation and initial protocol submission

HIPAA 

• Define HIPAA, protected health information, and covered entity
• Discuss HIPAA Authorizations and how they related to research
• Discuss Waivers to the HIPAA Authorization
• Provide tips for collecting HIPAA Authorization
• Identify how and when to report Privacy Violations

Investigational New Drug (IND) Sponsor and Investigator Responsibilities

• Define Investigational New Drug (IND), Sponsor, and Investigator
• Discuss the responsibilities of a Sponsor with an IND
• Discuss the responsibilities of an Investigator using an IND

Investigational Device Exemption (IDE) Sponsor and Investigator Responsibilities

• Define Investigational Device Exemption (IDE), Sponsor, and Investigator
• Discuss the responsibilities of a Sponsor with an IDE
• Discuss the responsibilities of an Investigator using an Investigational Device with an IDE

GCP - Drug Development 

Offered by CITI

• The GCP - Drug Development course covers Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) essential topics for clinical trials with investigational drugs and/or biologics. It is intended for research personnel involved in drug and/or biologic studies.

GCP - Device Development

Offered by CITI

• The GCP - Drug Development course covers Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) essential topics for clinical trials with investigational devices. It is intended for research personnel involved in device studies..

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)

Offered by CITI

• The GCP U.S. FDA Basic course covers Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) essential topics for clinical trials with investigational drugs, biologics, and/or medical devices. It is intended for research personnel involved in drug, biologic, or device studies and who would benefit from FDA-focused training. It covers key topics in clinical research including:
  • Reviewing FDA regulations
  • Identifying investigator and sponsor obligations
  • Discussing new drug development
  • Comparing International Council for Harmonisation (ICH) GCP E6 and FDA regulations
  • Describing how to detect and report adverse events
  • Auditing and monitoring expectations

Sponsor Monitoring and Audits

FDA Inspections

• Discuss the purpose of an FDA Inspection
• Identify the types of inspections the FDA conducts
• Walk through the Inspection process from initial notification to responding to deficiencies.

Reportable New Information

• Define Reportable New Information (RNI)
• Define the different categories of RNI
• Discuss the reporting requirements for RNI
• Discuss the process for amending the study as a result of an RNI

ClinicalTrials.gov Registration and Results Submission Overview

• Describe what ClinicalTrials.gov is
• Discuss how you should register your study (FDA, NIH & ICMJE)
• Identify FDA required informed consent language
• Identify who is responsible for registration (Responsible Party)
• Discuss results reporting requirements
• Describe how registration works at LSU Health New Orleans
• Identify Helpful Resources

Feasibility

Regulatory Closeout Basics for Clinical Research

• Prepare studies for regulatory closeout as dictated by institutional guidelines
• Recall the basics of document storage, including document retention

Developing the Informed Consent Form

• 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)

Informed Consent Process and Procedures for Clinical Research              

• 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. 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

Clinical Research Recruitment Regulations and Tools

• Discuss LSU Health New Orleans 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 patients.
• Discuss EPIC Tools as a means to identify eligible participants.
• Discuss using social media for Study Recruitment

Screening              

Study Visits

Electronic Management of Research Participants        

Specimen Management - Bloodborne Pathogens 

Specimen Management - Shipping Biological Materials 

Research-Related Agreements

• Identify typical contracts and agreements used in research
• Describe processes for putting agreements in place
• Identify notable clauses and language that are specific to LSUHSC contracts and agreements

Clinical Trial Agreements - Basics               

Offered by CITI

• CTAs are one of several key documents that govern the conduct of clinical trials. A CTA serves as a legally binding contract between a sponsor, site, and researcher, and outlines each party’s responsibilities and obligations for the clinical trial. It is imperative that researchers and sites understand the importance of CTA development, negotiation, and execution, as effectiveness in these areas will increase efficiency, protect researchers/sites and subjects, and help advance research.

Readability Fundamentals for Clinical Research Participant Engagement Materials 

Study Documentation Regulations and Best Practices

• 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

Using Veeva SiteVault (eRegulatory Binder)

Offered by Veeva

• Overview of Veeva SiteVault
• Managing Your Profile
• Overview of Studies
• Creating & Managing Studies
• Study Team Assignments
• Monitor & Auditor Assignments
• Managing Study Participants
• Overview of Documents
• Study eBinder
• Creating and Finalizing Documents
• Basics of Managing Documents
• Managing Source Documents
• Managing Monitoring Reviews 

Fundamentals of Clinical Research Data Management and Collection

• Identify the goals of research data management
• Summarize approaches for keeping data secure and avoiding errors
• Define the reason for data management
• Describe best practices for storing and sharing data to ensure data integrity and security
• Define data collection methodology
• Describe database design best practices
• Discuss tips and tricks for collecting data for research purposes.

Using REDCap for Clinical Research             

Data Security - Information Security 

Data Security - HIPAA Privacy in Research

Medicare Coverage Analysis 

• Describe processes for development of Medicare Coverage Analysis (MCA)

Clinical Trial Billing Compliance              

Offered by CITI

• Clinical Trial Billing Compliance (CTBC) provides individuals with training on clinical research billing compliance and best practices. This includes research staff, department administrators, registration staff, billing/coding staff, and others involved in the process or who are interested in working in research billing compliance.

Budgeting for Clinical Trials

• Describe processes for development & negotiation of budgets
• Identify the different costs associated with budget development

Clinical Trials Post-Award