New
Trending
SM
Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Trial Transparency Course & Certification
Intermediate
Watch Preview
4.7
★★★★★
97% Recommended
Updated 2026
4 hours
230 active users
3 points
Watch Preview
Your Study Basket
1 x Trial Transparency
| Total | |
🎁 FREE Bonus Included
eBookWorth £29— Yours FREE when you purchase today.
VAT is levied as per your country’s applicable rules and rates at checkout
Save more with a monthly or annual plan that includes this course
Each course includes:
eBook
Access the course content in eBook format, which can be downloaded and read on your device.
CPD Points
Certification
Affordable
Flexibility
Keep Up to Date
Learn from Industry Experts
Secure Payment Service
Rest assured we use secure processes to protect your payment.
Secured by:
About
GCP: Trial Transparency (EU CTIS, ClinicalTrials.gov and Results Disclosure) provides an advanced and practical overview of the principles, processes, and regulatory requirements necessary to register, maintain, publish, and disclose clinical trial information across European and US clinical trial systems.
This course covers key transparency requirements including EU CTIS registration, ClinicalTrials.gov requirements, trial record maintenance, results disclosure, publication timelines, document disclosure, personal data protection, commercially confidential information, protocol and status updates, results submission, and quality checks. Learners will understand how to manage trial transparency obligations across the EU and US regulatory frameworks to ensure that clinical trial information and results are accurate, complete, timely, and suitable for public disclosure. Upon successful completion, learners receive a certification demonstrating their practical understanding and application of clinical trial transparency and results disclosure requirements.
Who Should Enrol?
- Clinical Research and Clinical Operations Professionals
- Regulatory Affairs Professionals
- Clinical Trial Managers and Study Leads
- Medical Writers and Disclosure Specialists
- Data Management and Biostatistics Professionals
- Quality Assurance and Compliance Specialists
- CRO Professionals Supporting Clinical Trials
- Pharmaceutical, Biotechnology and Medical Device Professionals
- Anyone seeking specialized knowledge in clinical trial transparency and results disclosure
What you will learn
Build advanced knowledge of GCP trial transparency principles across EU CTIS and ClinicalTrials.gov.
Learn trial registration requirements, transparency rules, publication timelines, and results disclosure obligations.
Develop practical expertise in preparing, maintaining and updating trial records, results and disclosure documents.
Gain a thorough understanding of data protection, commercially confidential information, quality checks and ongoing transparency compliance.
Course Syllabus
- Registration Is Where the Duty Starts
- The Five Duties the US Rule Creates
- The EU Set and the UK Set Alongside
- The Studies Each Regime Does Not Reach
- Three Determinations, Three Definitions
- The Scope of Work and the Obligation Map
- What CTIS Is, and What It Puts in Public
- The Revised Rules, and the Deferral That Is Gone
- Three Categories, One Automatic Timetable
- Two Clocks: The Date It Is Due and the Date It Shows
- What You Actually Upload, and What It Does Not Catch
- Interim Results, the Derogation, and a Report Someone Else Owes
- Running Two Clocks When Nobody Tells You to Run Them
- Which Trials the US Regime Actually Reaches
- Registration Inside Twenty-One Days
- Keeping the Record Current: Three Different Intervals
- The Primary Completion Date, Defined Precisely
- The Second Clock, and What a Results Submission Contains
- Delay: The Certification, the Cap, and the Myth
- Submission Is Not the End
- The United States Record, Counted Honestly
- The Penalty Figure, and the Three Versions of It
- The Mechanism That Actually Bites
- The EU: A Penalty Regime With No Published Record
- What an Outsider Can Actually See
- Writing a Risk Register That Reflects Real Exposure
- The United Kingdom Duty, and What It Actually Says
- Which Studies It Reaches, and Which It Does Not
- The Deadline That Has Already Passed
- The Journal Gate: Lawful Is Not the Same as Publishable
- The Registry Landscape, Corrected
- Running Disclosure as an Operation
- Restated, because everything else hangs off them
- Registration was treated as the whole duty
- The display date was mistaken for the due date
- The clock was started at the wrong event
- The risk register was built around a fine never levied
- A lawful registration was made too late to publish
- What this course deliberately does not claim
- Find out what you actually owe
- Six things to re-check before you rely on this
- The Eight Things Worth Keeping
- 📘 Bonus: Trial Transparency eBook (Free with purchase)
Our Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
Frequently Asked Questions
This course provides comprehensive training on clinical trial transparency requirements under EU CTIS and ClinicalTrials.gov. It focuses on trial registration, record maintenance, results disclosure, document publication, data protection, commercially confidential information, and compliance with applicable disclosure timelines.
In this course, you will learn how to:
- Apply EU CTIS and ClinicalTrials.gov trial transparency requirements
- Determine applicable registration and results disclosure obligations
- Prepare and maintain accurate clinical trial records
- Manage trial results submission and publication requirements
- Handle personal data and commercially confidential information appropriately
- Manage protocol amendments, trial status updates, and record changes
- Perform quality checks to support accurate and timely disclosure
This course is designed for clinical research, regulatory, disclosure, and quality professionals involved in clinical trials, including:
- Regulatory affairs and clinical operations professionals
- Clinical trial managers and study coordinators
- Medical writers and clinical disclosure specialists
- Quality assurance and compliance professionals
- Data management and biostatistics teams
- CRO professionals supporting clinical trials
- Pharmaceutical, biotechnology, and medical device professionals
- Master practical clinical trial transparency requirements across EU CTIS and ClinicalTrials.gov
- Understand trial registration, results disclosure, and publication timelines
- Improve the accuracy and consistency of public clinical trial records
- Manage data protection and commercially confidential information considerations
- Strengthen professional credentials with specialized expertise in clinical trial transparency
Best Seller
