CLINICAL RESEARCH NURSE

Get oriented with your course, meet your instructor, and master key resources, acronyms, and terminology.

• Instructor intro
• Course structure 
• Assignments & final project overview
• Resource & acronym lists
• Glossary

Understand the CRN’s role in the healthcare ecosystem, distinguish it from CRCs and PIs, and discover how clinical skills translate into research impact.

• Clinical research within the healthcare ecosystem
• Discussion: Where does clinical research occur? 
• Clinical Research Nurse vs. other roles 
• Transferring bedside care skills to clinical research cases
• CRN/CRC competencies that improve study outcomes
• Case Study: Historical cases that changed everything Pt.1: Nuremberg, Tuskegee, Willowbrook, Henrietta Lacks

Learn from history to navigate modern ethics. Apply lessons from landmark cases to today’s regulatory and AI-driven research environments.

• Case Study: Historical cases that changed everything Pt.2: Nuremberg, Tuskegee, Willowbrook, Henrietta Lacks
• Discussion: What would a CRN do differently today?
• Interactive timeline matching abuse to regulations
• Birth & purpose of Institutional Review Boards
• Contemporary ethical challenges: AI & decentralized trials
• Discussion: eConsent & AI in research setting

Decode core regulations (FDA, EMA, ICH-GCP, MHRA), assess site feasibility, and ensure readiness for compliant study initiation.

• Roles of FDA, OHRP, EMA & MHRA: Comparison 
• ICH-GCP core sections every CRN/CRC should know
• How feasibility assessments feed regulatory submissions
• Audits & inspections: Compliance starts from day one

Assignment #1: Regulatory & Compliance Framework
Identify the specific FDA regulations (21 CFR) and ICH-GCP guidelines that govern your daily tasks. Complete a mock Delegation of Authority (DOA) Log to understand the legal boundaries of the CRN role.

Apply GCP principles to identify protocol deviations, resolve ethical dilemmas, and safeguard study integrity in real-world scenarios.

• Applying GCP to protocol adherence, consent & documentation
• Case Study: The SUPPORT trial: Consent failure & GCP breakdown
• Common GCP violations research nurses/study coordinators can prevent
• Ethical dilemmas mapped to relevant GCP clauses
• Workshop: Spotting deviations in sample progress notes

Break down complex protocols into actionable workflows, aligning inclusion/exclusion criteria and schedules with everyday clinical operations.

• Objectives, methodology, assessment schedules
• Interpreting inclusion & exclusion criteria
• Aligning everyday clinical tasks to protocol requirements
• Overview of where deviations live
• Workshop: Criteria clarity: Discerning & fixing ambiguous criteria

Assignment #2: Protocol Operational Analysis
Using a sample protocol, extract the Inclusion/Exclusion criteria and create a Table of Events (ToE) summary. Identify three "red flag" areas where a protocol deviation is most likely to occur.

Build a complete site start-up plan. Organize documents, coordinate teams, and translate feasibility insights into operational readiness.

• Feasibility confirmation checklist: Patients, staffing, facilities
• Site initiation visit: What to prepare
• Investigational product receipt, storage & temperature logging fundamentals
• Essential regulatory documents + DOA Log
• Collaboration: Pharmacy, radiology, nuclear medicine, lab, & other teams
• Demo: Creating a site start-up checklist

Design recruitment and consent strategies that are ethical, clear, and participant-friendly while maximizing retention.

• Participant recruitment in clinical research
• Retention strategies & participant experience
• Screening & eligibility verification
• Informed consent: Beyond the signature
• Digital consent & regulatory considerations
• Workshop: Simplifying a complex jargon text

Assignment #3: Participant Enrollment & Consent Suite
Develop a Pre-Screening Checklist, a Participant Recruitment Plan, and a "Plain Language" Consent Script used to explain a study to a potential participant without using medical jargon.

Learn how to ensure flawless data capture. Apply ALCOA+ principles, spot discrepancies, and maintain data integrity from source to CRF.

• Source documentation vs. CRFs 
• ALCOA+ principles
• Paper to eCRF transcription practice: Finding discrepancies
• Common data entry errors & prevention tips
• Demo: Source-to-CRF transcription drill

Protect participant data in electronic systems, manage access and audit trails, and evaluate security risks with confidence.

• Overview of common EDC systems: Medidata, REDCap
• CRN/CRC responsibilities during data entry
• Protecting confidentiality: HIPAA & CFR 
• Audit trails & access logs: What to know
• Workshop: Analyzing a data privacy scenario 
• Security checklist for remote access

Learn how to classify, report, and respond to safety events accurately, keeping participants safe and studies compliant.

• Detecting, grading, reporting: AEs, AESI, SAEs, SUSARs
• Decision tree worksheet for seriousness classification
• Case Study: The Dan Markington case from the CAFÉ trial
• Emergency unblinding: CRN/CRC responsibilities
• PDs & CAPA plan basics linked to safety lapses

Assignment #4: Data Integrity & Source Documentation
Practice a "Source-to-EDC" transcription exercise. Draft a "Gold Standard" Study Visit Note using ALCOA+ principles, ensuring all entries are attributable, legible, and contemporaneous.

Master investigational product handling, storage, accountability, and CAPA planning to prevent and correct deviations.

• Pharmacy manual
• Collaboration protocol: CRN/CRC–pharmacist handoff
• Blinding vs. open-label dispensing workflows
• Temperature logs, devices, excursions & documenting CAPA
• Coordinating returns & destruction with sponsor or depot
• Demo: Reconciliation of drug accountability logs 

Assignment #5: Safety Monitoring & CAPA Plan
Categorize a set of medical events as AEs or SAEs. Draft a CAPA plan responding to a simulated "Temperature Excursion" in the investigational product storage.

Prepare for audits by reviewing documentation, anticipating findings, and implementing corrective strategies with expert insights.

• Regulatory binder: Required sections & upkeep
• Additional FDA audit basics
• Discussion: What findings do you think are in the top ten?
• What CRAs or monitors inspect during routine monitoring site visits
• Guest Speakers: Ms. Kimberly Shaw, Senior CRA & Ms. Sallie O’Connor, Clinical Lead

Get tips on how to collaborate effectively in multidisciplinary teams. Manage conflict, maintain transparency, and foster psychological safety.

• Communication matrix: Who to notify, when & how
• Conflict resolution: Documentation, communication escalation protocols, etc.
• Best practice documentation for inter-role transparency
• Maintaining motivation & psychological safety in study teams

Final Project: Clinical Research Site Operations Portfolio
A comprehensive collection of site-level documentation and operational tools. This portfolio demonstrates your ability to interpret a protocol, manage participant safety, ensure data integrity, and maintain regulatory compliance according to FDA and ICH-GCP standards.

Connect trial outcomes to healthcare practice and policy. Communicate findings clearly to stakeholders for real-world impact.

• How evidence from trials impacts clinical practice
• Presenting findings to stakeholders
• Case Study: A trial result that changed hospital policy: Henrietta Lacks
• Tools for CRN/CRC to stay research-informed

Explore certification routes, career paths, and job-search strategies to plan your professional growth in clinical research.

• Certification routes: ACRP, SOCRA, CITI refreshers
• Building a standout LinkedIn profile 
• Interview preparation tips
• CRN job boards