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Registration of Clinical Trials Course & Certification
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4.8
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Updated 2026
2 hours
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Fully compliant
This course describes the compliance requirements for the reporting of adverse events relating to medical devices. Learners also receive 4 Continual Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.
Reliable and trustworthy
This course was written by Steve Jolley, a recognised expert in International drug and device vigilance. You will stay up to date with any international legislative changes in device vigilance as our training courses are constantly monitored, reviewed and updated (last updated in May 2018). Steve Jolley is a Cambridge University graduate with 25 years’ experience in drug & device safety & vigilance, who specializes in global safety compliance, business process improvement and signal detection. He is the Chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America and has worked with over 80 clients in the US, Europe and Japan. He is a featured speaker with the FDA and MHRA at DIA conferences and webinars on drug safety topics including auditing and signaling.)
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About
The Registration of Clinical Trials Course is designed to provide a comprehensive understanding of the requirements and processes involved in registering clinical trials with national and international trial registries. It focuses on promoting transparency, regulatory compliance, and public access to clinical research information.
This course covers key aspects of clinical trial registration, including registry requirements, submission processes, protocol information disclosure, updates and maintenance of trial records, and reporting obligations. It also emphasizes Good Clinical Practice (GCP), regulatory expectations, and compliance with global clinical trial transparency standards. Upon completion, learners receive a certification demonstrating competency in clinical trial registration processes.
Who Should Enrol?
- Clinical Research Associates (CRAs)
- Clinical Trial Assistants (CTAs)
- Study Coordinators
- Investigators and Sub-Investigators
- Clinical Project Managers
- Sponsor Representatives
- Contract Research Organisation (CRO) Personnel
- Research Nurses
- Ethics Committee / Institutional Review Board Members
- Regulatory Affairs Professionals
- Quality Assurance and Compliance Personnel
What you will learn
Understand the regulatory requirements for clinical trial registration, including sponsor and investigator responsibilities, Applicable Clinical Trials (ACTs), and global registration frameworks.
Learn the clinical trial registration process, including protocol registration, reporting requirements, results submission, and management of records within registry systems.
Gain knowledge of international standards such as WHO trial registration requirements, study identifiers (NCT Number and UTN), and key registry data elements.
Develop awareness of quality control reviews, data submission standards, audit readiness, and compliance requirements to ensure accurate, transparent, and publicly accessible clinical trial information.
Course Syllabus
- Who is the Responsible Party?
- Sponsor Responsibilities — Overview
- Applicable Clinical Trials (ACTs) & FDAAA 801
- Regulatory vs. Financial Sponsor
- Investigator / Researcher Responsibilities
- PI Accountability: FDA Form 1572
- The Protocol Registration & Results System PRS
- NLM QC Review & the NCT Number
- Reporting & Update Requirements
- Results Reporting on ClinicalTrials.gov
- The WHO ICTRP — International Framework
- WHO Trial Registration Data Set TRDS
- Who Needs to Register?
- Timing Requirements for Registration
- Post-Registration Procedures
- Content Standards & Registry Data Elements
- Study Identification Module — Key Fields
- Intellectual Property (IP) & Data Ownership
- The NCT Number — National Clinical Trial Identifier
- Universal Trial Number UTN
- NCT Number vs. UTN — Side by Side
- NLM Quality Control (QC) Review Process
- Common QC Failures & How to Avoid Them
- WHO Primary Registry Criteria
- Accessibility Requirements
- Data Submission Methods for ClinicalTrials.gov
- CDISC CTR-XML Standard
- FDA BIMO Program — Bioresearch Monitoring
- Consequences of Non-Compliance
- BIMO Audit Readiness Checklist
- Key Takeaways
- Glossary of Key Terms — Part 1
- Glossary of Key Terms — Part 2
- References & Further Resources
- 📘 Bonus: Registration of Clinical Trials eBook (Free with purchase)
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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
- 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
