AI + EDC Sponsor Readiness Week

8 Hours of Applied Training Across 5 Days

  • Duration: 5 sessions (2 hours each)

  • Delivery: Live via Zoom + Replay Access

  • Certificate: AI + EDC Source Data Verification & Quality Assurance Training (CSRS Academy)

  • Audience: Sponsors | CRO Leads | Aspiring Site Owners | Physicians | Research Entrepreneurs

  • 50 Quiz Questions with a passing score of 80%

Course curriculum

    1. Lesson 2: Regulatory Landscape & Context

    2. Lesson 3: Sponsor & CRO Obligations in Practice (25 min)

    3. Lesson 4: Case Study Review – FDA 483 Letters (25 min)

    4. Lesson 5: Technology & AI Alignment with Regulatory Mandates (25 min)

    5. Lesson 6: Group Activity – Mock Oversight Plan & Audit Mapping (20 min)

    6. Day 1: Regulatory Oversight & FDA Quiz

    1. Lesson 1:What is a Certificate of Analysis (CoA)? (25 min)

    2. Lesson 2: Understanding eCRFs (Electronic Case Report Forms)

    3. Lesson 3: Connecting the Dots: CoA → eCRF → Sponsor Oversight (0:45 – 1:05)

    4. Lesson 5: QA Reflection & Audit Readiness Activity (1:40 – 2:00)

    5. Day 2: Affinda AI Demo Quiz

    1. Lesson 1: What is OpenClinica & Why It Matters (20 Minutes)

    2. Lesson 2: System Architecture & FDA Part 11 Requirements (0:20 – 0:40 min)

    3. Lesson 3: Source-to-eCRF Verification Workflow (0:40 – 1:10)

    4. Lesson 4: Audit Trails, CAPA Tracking & QA Reports (1:10 – 1:35)

    5. Lesson 5: Reflection + Practical Compliance Alignment (1:35 – 2:00)

    6. Day 3: OpenClinica EDC Quiz

    1. Lesson 1: What is Risk-Based Monitoring (RBM)? (25 min)

    2. Lesson 2: The Regulatory Foundation for Risk-Based Oversight (0:25 – 0:45)

    3. Lesson 3: Using AI for Risk Detection and Data Quality Insights (0:45 – 1:10)

    4. Lesson 4: CAPA Documentation: Corrective and Preventive Action Systems (1:10 – 1:35)

    5. Lesson 5: Sponsor-Level Readiness & Live Case Simulation (1:35 – 2:00)

    6. Day 4: RBM & Capa Quiz

    1. Lesson 1: The Sponsor’s Perspective: What Auditors Expect (0:00 – 0:25)

    2. Lesson 2: Anatomy of an FDA or Sponsor Audit (0:25 – 0:45)

    3. Lesson 3: Mock Sponsor Visit: Data Verification & System Demonstration (0:45 – 1:15)

    4. Lesson 4: Responding to Audit Findings & CAPA Integration (1:15 – 1:35)

    5. Lesson 5: Building Long-Term Sponsor Relationships (1:35 – 2:00)

    6. Day 5: Sponsor Simulation & QA Audit Quiz

About this course

  • $997.00
  • 29 lessons
  • 0 hours of video content

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Course Overview

This exclusive 2-hour masterclass bridges AI innovation, FDA oversight, and real-world operational execution. Participants will experience how Affinda’s AI document-parsing system and OpenClinica’s EDC platform work together to strengthen data integrity, audit readiness, and sponsor confidence. Unlike traditional EDC or compliance webinars, this session is led by Alisha Moore CEO -CSRS & Founder of I.A.M. Research & Wellness Foundation, who brings 15 years of lab, regulatory, and site-startup experience — translating complex FDA expectations into clear, actionable workflows for clinical entrepreneurs and executives.