CRCM Phase 1: Clinical Research Training - CRCM Foundation & Training

1. Week 1: Clinical Research Foundations & GCP

   19 lessons

   1. Self-Paced Pre-Work

      1. Welcome to CRCM Phase 1
      2. The Clinical Research Ecosystem
      3. Clinical Trial Phases (I-IV) Explained
      4. Key Stakeholders: Sites, Sponsors, CROs
      5. Introduction to ICH GCP E6(R3)
      6. Reading: ICH E6(R3) Sections 1-3
      7. Pre-Work Knowledge Check Quiz

   2. Monday Q&A Session

      1. Monday Feb 2 | Q&A Introductions (7-8 PM EST)
      2. Your Assigned Study Protocol

   3. Wednesday Core Teaching

      1. Join Live: Protocol Anatomy Deep Dive
      2. Your Assigned Study Protocol
      3. Protocol Analysis Framework

   4. Saturday Project Work

      1. Join Live: Protocol Analysis Workshop
      2. Protocol Analysis Worksheet
      3. Case Study Scenarios
      4. Capstone Project Overview

   5. Weekly Project Submission

      1. Project Instructions: Protocol Analysis Summary
      2. Submit Week 1 Project
      3. Submit Week 1 Project

2. Week 2: Ethical Conduct & Regulatory Framework

   12 lessons

   1. Self-Paced Pre-Work

      1. History of Research Ethics: Nuremberg to Belmont
      2. The Informed Consent Process
      3. IRB/IEC: Roles & Responsibilities
      4. Vulnerable Populations & Special Protections
      5. Drug Development Pipeline: IND to NDA
      6. FDA Regulations: 21 CFR Parts 11, 50, 56, 312
      7. Reading: ICH E6(R3) Sections on IRB/Investigator
      8. Pre-Work Knowledge Check

   2. Monday Q&A Session

      1. Questions on ethics and regulatory concepts

   3. Wednesday Core Teaching

      1. ICF deep dive, consent element review, common errors

   4. Saturday Project Work

      1. Project Work: ICF review exercise, IRB submission simulation

   5. Weekly Project

      1. Week 2 Project Submission

3. Week 3: Clinical Study Operations & Site Management

   12 lessons

   1. Self-Paced Pre-Work

      1. Patient Recruitment Strategies
      2. Screening & Eligibility Assessment
      3. Visit Scheduling & Coordination
      4. Conducting a Patient Visit: Checklists & Compliance
      5. Reading: Site Operations Best Practices
      6. Protocol Deviations & Violations
      7. Randomization, Blinding & Unblinding Procedures
      8. Pre-Work Knowledge Check Quiz

   2. Monday Q&A Session

      1. Questions on site operations concepts

   3. Wednesday Core Teaching

      1. A Day in the Life of a CRC, workflow demonstration

   4. Saturday Project Work

      1. Screening visit coordination role-play

   5. Weekly Project

      1. Submit Project 3: Screening Documentation & Visit Planning

4. Week 4: Data Management & EDC Systems

   0 lessons

5. Week 5: Safety Monitoring & Adverse Events

   0 lessons

6. Week 6: Quality, Monitoring & Career Launch

   0 lessons