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About

This course on GCP – Registration of Trials on Clinical Trials provides a clear overview of regulatory requirements for trial registration. It covers global registries, submission processes, and compliance with ethical and legal standards. Participants will learn how to ensure transparency, accuracy, and timely updates of clinical trial information. The program emphasizes practical skills to maintain compliance and support audit readiness throughout the study lifecycle.

Course Syllabus

  1. Who is the Responsible Party?
  2. Sponsor Responsibilities — Overview
  3. Applicable Clinical Trials (ACTs) & FDAAA 801
  4. Regulatory vs. Financial Sponsor
  5. Investigator / Researcher Responsibilities
  6. PI Accountability: FDA Form 1572

  1. The Protocol Registration & Results System PRS
  2. NLM QC Review & the NCT Number
  3. Reporting & Update Requirements
  4. Results Reporting on ClinicalTrials.gov

  1. The WHO ICTRP — International Framework
  2. WHO Trial Registration Data Set TRDS
  3. Who Needs to Register?
  4. Timing Requirements for Registration
  5. Post-Registration Procedures

  1. Content Standards & Registry Data Elements
  2. Study Identification Module — Key Fields
  3. Intellectual Property (IP) & Data Ownership
  4. The NCT Number — National Clinical Trial Identifier
  5. Universal Trial Number UTN
  6. NCT Number vs. UTN — Side by Side

  1. NLM Quality Control (QC) Review Process
  2. Common QC Failures & How to Avoid Them
  3. WHO Primary Registry Criteria
  4. Accessibility Requirements

  1. Data Submission Methods for ClinicalTrials.gov
  2. CDISC CTR-XML Standard
  3. FDA BIMO Program — Bioresearch Monitoring
  4. Consequences of Non-Compliance
  5. BIMO Audit Readiness Checklist
  6. Key Takeaways
  7. Glossary of Key Terms — Part 1
  8. Glossary of Key Terms — Part 2
  9. References & Further Resources

Our Certified Customers

novartis
NHS
takeda
roche
baxter

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RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

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Frequently Asked Questions

This course on GCP – Registration of Trials on Clinical Trials builds a strong foundation in global requirements for registering and maintaining clinical study records. It focuses on regulatory compliance, transparency, and best practices to ensure accurate reporting and audit readiness throughout the trial lifecycle.

  • Overview of global clinical trial registries and registration requirements
  • Step-by-step process for submitting and updating trial information
  • Regulatory and ethical compliance for trial transparency
  • Key data elements required for accurate trial registration
  • Timelines and responsibilities for maintaining registry records
  • Common challenges and best practices in trial registration
  • Audit readiness and inspection considerations
  • Alignment with international GCP guidelines and standards

This course is ideal for professionals involved in clinical trial registration and compliance, including:

  • Clinical Research and Regulatory Affairs professionals
  • Clinical Trial Coordinators and Study Managers
  • Quality Assurance and compliance teams
  • Investigators and site staff responsible for trial documentation
  • Anyone seeking to understand global clinical trial registry requirements and GCP principles
No prior experience is required, though a basic understanding of clinical research or GCP is beneficial.

  • Comprehensive training on global clinical trial registration requirements and processes
  • Aligned with international GCP guidelines and regulatory expectations
  • Practical guidance on submitting, updating, and maintaining registry records
  • Focus on transparency, data accuracy, and compliance best practices
  • Enhances audit readiness and inspection preparedness
  • Certificate issued upon successful completion