Course Syllabus

Program Curriculum

Updated January 2026 · Version 2026.1 · Aligned with ICH-GCP E6(R3) and TransCelerate minimum criteria

80h

CPD Hours

6 + Final

Modules

Lessons

80%

Pass Mark

Standards Alignment

The curriculum follows the Minimum Criteria for ICH-GCP Investigator Site Personnel Training defined by TransCelerate BioPharma and the ICH-GCP E6(R3) guideline (effective 2025). Content also references FDA 21 CFR Parts 11/50/56/312, EU CTR 536/2014, the Declaration of Helsinki, and IATA DGR 2025.

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Module 1

Courses & Certifications for CRC

Discover the leading certification programs that strengthen the professional profile of a Clinical Research Coordinator.

8 CPD hours4 lessons · 1.1h readingQuiz · 5 questions · 80% passCase study

Learning Objectives

Identify the main international CRC certifications (ACRP CCRC, SOCRA CCRP, PRCCI, CCRPS, Icesi)
Compare eligibility requirements, costs and recognition of each certification body
Select the most appropriate certification path based on career stage and region
Explain the relationship between continuing education and professional credentialing

Lessons

· The CRC Role & Career Path (20 min)
· PRCCI 2025 Certification (15 min)
· Universidad Icesi (Colombia) (15 min)
· CCRPS Certification (15 min)

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Module 2

Research Basics Part 1 — Fundamentals, Protocols & Ethics

Establish the conceptual foundations of clinical research: study types, protocol design, ethics, and informed consent.

14 CPD hours4 lessons · 1.5h readingQuiz · 5 questions · 80% passCase study

Learning Objectives

Define clinical research and distinguish observational vs interventional studies
Interpret the key components of a clinical trial protocol
Apply the ethical principles of the Declaration of Helsinki and Belmont Report
Conduct a compliant informed consent process aligned with ICH-GCP E6(R3)

Lessons

· What Is Clinical Research? (20 min)
· The Research Protocol (25 min)
· Ethics in Clinical Research (25 min)
· Informed Consent Process (20 min)

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Module 3

Research Basics — Clinical Trial Phases

Understand the complete drug development lifecycle from Phase 1 safety studies through Phase 4 post-market surveillance.

12 CPD hours5 lessons · 1.5h readingQuiz · 5 questions · 80% passCase study

Learning Objectives

Describe the objectives, population and endpoints of Phases 1 through 4
Differentiate FIH, dose-finding, pivotal and post-marketing studies
Explain the role of the CRC in each phase of clinical development
Recognize success rates and key risks across the drug development lifecycle

Lessons

· Preclinical Development & IND (15 min)
· Phase 1 — Safety & Pharmacokinetics (20 min)
· Phase 2 — Efficacy & Dose Finding (20 min)
· Phase 3 — Pivotal Confirmatory Trials (20 min)
· Phase 4 — Post-Market Surveillance (15 min)

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Module 4

Good Clinical Practice (GCP) per ICH E6(R3) — Principles & Responsibilities

Master the regulatory framework and the 11 fundamental principles of ICH-GCP E6(R3), aligned with the TransCelerate Minimum Criteria for Investigator Site Personnel.

16 CPD hours5 lessons · 2h readingQuiz · 12 questions · 80% passCase study

Learning Objectives

Apply the 11 fundamental principles of ICH-GCP E6(R3) to daily site operations
Distinguish responsibilities of Sponsor, Investigator, CRC and IRB/IEC under E6(R3) Annex 1
Implement Quality by Design, risk-proportionate management and data governance
Classify and report Adverse Events and Serious Adverse Events within regulatory timelines
Document and manage protocol deviations and prepare the site for audits and inspections
Meet the TransCelerate BioPharma Minimum Criteria for Investigator Site Personnel GCP training

Lessons

· The Regulatory Landscape (20 min)
· The 11 Principles of ICH-GCP E6(R3) (30 min)
· Data Governance, Quality by Design & Risk-Based Quality Management (25 min)
· Sponsor, PI & CRC Responsibilities (20 min)
· AE/SAE Reporting & Protocol Deviations (25 min)

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Module 5

IATA — Safe Transport of Biological Specimens

Learn to handle, package, and ship biological samples safely in compliance with international IATA regulations.

10 CPD hours3 lessons · 0.8h readingQuiz · 5 questions · 80% passCase study

Learning Objectives

Classify biological specimens as Category A (UN2814) or Category B (UN3373)
Assemble compliant triple packaging meeting Packing Instruction P650
Complete shipper's declaration and chain-of-custody documentation
Manage temperature excursions and shipping incidents per IATA DGR

Lessons

· Introduction to IATA in Clinical Research (15 min)
· The Triple Packaging System (20 min)
· Shipping Documentation & Chain of Custody (15 min)

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Module 6

Tools & Software Used by CRCs

Explore the digital platforms and software systems that CRCs use daily: EDC, CTMS, eTMF, eConsent, and more.

12 CPD hours3 lessons · 0.9h readingQuiz · 5 questions · 80% passCase study

Learning Objectives

Operate major EDC platforms (Medidata Rave, Veeva Vault, Oracle Clinical One)
Manage essential documents in eTMF/eISF systems (Florence, Veeva)
Apply 21 CFR Part 11 requirements for electronic records and signatures
Maintain data integrity using ALCOA+ principles across CTMS workflows

Lessons

· Electronic Data Capture (EDC) (20 min)
· CTMS & eTMF Platforms (20 min)
· General Productivity & Recommendations (15 min)

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Final Assessment

Final Integrative Exam

Comprehensive assessment covering all 6 modules. Required for certificate issuance. Minimum passing score: 80%.

8 CPD hours10+ scenario-based questions