Recordings of each week will be added below, links are restricted to OSUMC users.

Week Recording Link (Fall 2025)
1 Week 1
2 Week 2
3 Week 3
4 Week 4
5 Week 5
6 Week 6
Subfolder File Name Created Modified
📁/Week 1 SOCRA Mindset
  • Week 1 Homework
  • Week 1 Overview
  • Week 1 Remediation
  • Week 1 Student Workbook & Templates
  • 2025-10-17
  • 2025-10-17
  • 2025-10-17
  • 2025-10-17
  • 2025-10-24
  • 2025-10-20
  • 2025-10-24
  • 2025-10-20
📁/Week 2 Informed Consent
  • Week 2 In-Class Activities
  • Week 2 Homework
  • Week 2 Overview
  • Week 2 Visual Aids
  • 2025-10-17
  • 2025-10-17
  • 2025-10-17
  • 2025-10-27
  • 2025-10-25
  • 2025-10-20
  • 2025-10-31
  • 2025-10-27
📁/Week 2 Informed Consent/Reference
  • 21 CFR Part 50 Info
  • 2025-10-17
  • 2025-10-31
📁/Week 3 IRB
  • Week 3 Homework
  • Week 3 Targeted Understanding
  • Week 3 Visual Aids
  • Week 3 Remediation
  • Week 3 Overview
  • 2025-10-20
  • 2025-11-03
  • 2025-10-20
  • 2025-10-20
  • 2025-10-20
  • 2025-11-10
  • 2025-11-03
  • 2025-10-20
  • 2025-10-20
  • 2025-10-31
📁/Week 4 IDE IND
  • Week 4 IND and IDE Regulations and Responsibilities
  • Week 4 Remediation
  • Week 4 Overview
  • 2025-10-22
  • 2025-11-03
  • 2025-10-20
  • 2025-11-10
  • 2025-11-03
  • 2025-11-17
📁/Week 4 IDE IND/Gemini Interactives
  • Week 4 IND IDE Visuals
  • 2025-10-27
  • 2025-11-03
📁/Week 4 IDE IND/Reference
  • 21 CFR Part 312 and 812
  • 2025-10-22
  • 2025-11-10
📁/Week 5 ICH GCP E6 R3
  • Week 5 Overview
  • 2025-10-25
  • 2025-11-17
📁/Week 5 ICH GCP E6 R3/Reference
  • ICH E6 R2 to R3 Transition Study Guide
  • ICH E6(R3) Transition
  • ICH E6 R3 Visual Aids
  • 2025-10-25
  • 2025-10-25
  • 2025-10-25
  • 2025-11-11
  • 2025-10-25
  • 2025-10-25
📁/Week 6 Data and Monitoring
  • Week 6 Overview
  • 2025-11-03
  • 2025-11-17
📁/Week 7 AEs
  • Week 7 Learning Materials
  • Week 7 Overview
  • Week 7 Study Guide
  • 2025-11-02
  • 2025-11-04
  • 2025-11-02
  • 2025-11-03
  • 2025-11-04
  • 2025-11-04

Welcome to my repository for information from my SOCRA Preparation class that I do at OSU.
If you want to talk to the digital version of everything I know, you can try talking to my SOCRA NotebookLM Chatbot.

You can reach me by email david.spatholt @ osumc.edu if you have questions.

We are currently (Fall 2025) meeting Mondays at noon.

Readings

I recommend two books be read to prepare:

  1. The Comprehensive Guide to Clinical Research by Dan Sfera or AudioBook
  2. Lessons from a Horse Named Jim

Here's how to go about reading them:

Week Course Topic "Lessons from a Horse Named Jim" "The Comprehensive Guide to Clinical Research" (Dan Sfera) Notes & Rationale
1 Orientation & SOCRA Mindset Ch. 1: History & Events Ch. 3: GCP & Regulations Ch. 1: Bird's Eye View Ch. 3: Regulations Start with the big picture. Horse Jim provides the historical "why," while Sfera gives a practical overview of the modern landscape and regulations.
2 21 CFR Part 50 & Informed Consent Ch. 4: Informed Consent Review Ch. 3 (Regulations) and Ch. 4 (Site Level Dynamics) for mentions of consent. Horse Jim is your primary text here with its dedicated chapter. Sfera's guide integrates consent principles into broader operational chapters.
3 IRB Requirements Ch. 5: Institutional Review Boards Review Ch. 3 (Regulations). Again, Horse Jim provides the deep dive on IRBs. In Sfera's book, IRB interactions are a key part of the general regulations chapter.
4 IND Regulations Ch. 2: The Process... Ch. 8: The Principal Investigator Ch. 12: Study Documents (re: 1572) Ch. 6: CRO/Sponsor Dynamics Combine the regulatory process (Horse Jim) with the practical dynamics between sites and sponsors who hold the IND (Sfera).
5 ICH GCP & E6(R3) Transition Ch. 3: GCP & Regulations (Re-read) Ch. 3: Regulations (Re-read) Re-read both chapters on regulations to solidify your understanding of Good Clinical Practice, the foundation for all ICH guidelines.
6 Monitoring & Data Management Ch. 7: Monitoring, Audits... Ch. 14: Managing Clinical Trial Data Ch. 5: Monitoring Ch. 4: Site Level Dynamics (re: Source/Reg Docs) Sfera provides an excellent, practical guide to monitoring visits, which perfectly complements the regulatory perspective in Horse Jim.
7 Adverse Event Reporting Ch. 6: Adverse Events and UPs Ch. 4: Site Level Dynamics (re: SAEs and SUSARs) A perfect pairing. Horse Jim explains the regulatory requirements for AE reporting, while Sfera covers the practical site-level process.
8 Protocol Development Ch. 9: The Protocol Ch. 10: Study Feasibility Ch. 2: Phases and Design of Clinical Trials Use Sfera's chapter for the fundamentals of trial design and phases, then dive deep into protocol structure and feasibility with Horse Jim.
9 Study Conduct Ch. 11: Study Activities Ch. 13: Management of Study Drugs... Ch. 4: Site Level Dynamics (re: SOPs, Staff, QA) Horse Jim outlines the phases of study activities, while Sfera provides crucial details on the site-level infrastructure (staff, SOPs, QA) needed to conduct them.
10 Study Closeout Ch. 11: Study Activities (re: Close-Out) Ch. 12: Study Documents (re: Close-Out) Ch. 5: Monitoring (re: Close Out Visits) Focus on the close-out sections from both books to understand the regulatory requirements and the practical steps of a close-out visit.
11-12 Comprehensive Review Review All Assigned Chapters Review All Assigned Chapters Revisit all assigned readings, focusing on your weak areas identified in practice quizzes. The two books should now provide a complete regulatory and practical picture.

Other Resources