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European Clinical Trial Regulation

Are you ready for the EU Clinical Trial Regulation?
We are ready to help you!

Implementation of the EU Clinical Trial Regulation 2014 No. 536 (the CTR) starts on 31 January 2022. It is important that both sponsors and investigators are aware of the significant changes and new requirements.

Our three new on-demand, online courses offer training

  • for those needing a high-level overview
  • for those needing more in-depth knowledge
  • for the investigator site members who need awareness of how the CTR changes their responsibilities and working practices.

The courses are interactive, personalized using participants name and have both narrated and read-only options.

On completion of these courses, participants are able to print a certificate of completion for their training records.

The courses are delivered using Brookwood’s Articulate Rise learning management platform. This allows participants to set their own password and access their training dashboard.

For group participation, we are able to track activity and provide progress and completion reports to the training organizers.

Alternatively, the course can be provided to organizations under license as ‘Scorm files’ to be delivered on their own learning management system.

Online Training
Essential Guide to the EU CTR
This online, on-demand course covers the main content and requirements of the EU Clinical Trial Regulation 2014 No. 536 (the CTR).
Implementation of the CTR starts on 31 January 2022. Sponsors will have the option of starting trials in accordance with the CTR from this date. It is important that both sponsors and investigators are aware of the changes and new requirements.
Our course is interactive and has both narrated and read-only options. The course is personalized using participants name.
At the end of the course participants are able to print a certificate of completion for their training records.
The course is delivered using Brookwood’s Articulate Rise learning management platform. This allows participants to set their own password and access their training dashboard. We are able to track activity and provide progress and completion reports to the training organizers.Alternatively, the course can be provided to organizations under license as Scorm files to be delivered on their own learning management system.

CTR for All- a high-level overview of the European Clinical Trial Regulation
This 15-20 minute on-demand, on-line course is ideal for those needing a short, high-level introduction to the EU Clinical Trial Regulation.
It covers the main changes to working practices and highlights some of the new important requirements.
Participants can choose between a narrated and read-and-click version. The course is interactive and personalised with participant’s name.

Clinical Investigator Site Awareness: the EU Clinical Trial Regulation
This short 20-minute course provides investigators and members of the study team with a heads-up on what clinical trial staff need to know about the CTR.
It highlights what is new and different, and what has changed from the previous EU requirements. 

Virtual Course
The EU Clinical Trial Regulation
Contact us for next course details.
Interactive, up-to-date and innovative.
Day 1 overviews the current status and summarizes the content of the CTR.
Day 2 looks at the guidelines, related Regulations, CTIS, Q&A document and implementation considerations.

Customised in-house webinars can be arranged … just ask!

 

Publications
We offer a uniquely indexed reproduction of the European Clinical Trial Regulation 2014  No. 536 as published in the Official Journal on 27 May 2014.
The unique Brookwood index of subject headings and key words helps users find the appropriate sections quickly and easily. The index also cross-references the Clinical Trials Directive 2001/20/EC, the Declaration of Helsinki and ICH GCP. Available in paper format in A5 and pocketbook and as an e-book


 

 

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The EU Clinical Trial Regulation Virtual Course
The EU Clinical Trial Regulation. Day 1 overviews the current status and summarizes the content o..
£675.00
Based on 18 reviews.
Essential Guide to the EU Clinical Trial Regulation
Essential Guide to the EU Clinical Trial Regulation This online, on-demand course covers in more ..
£100.00
Managing and reporting serious breaches of the EU Clinical Trial Regulation
Managing and reporting serious breaches of the EU Clinical Trial Regulation The EU Clinical Trial..
£80.00
CTR for ALL - a high-level overview of the EU Clinical Trial Regulation
CTR for ALL - a high-level overview of the EU Clinical Trial Regulation This 15-20 minute course ..
£50.00
Clinical Investigator Site Awareness: the EU Clinical Trial Regulation
This short 20-minute course provides investigators and members of the study team with a heads-up on ..
£50.00
e-book European Clinical Trial Regulation No. 536/2014
A uniquely indexed copy of the European Clinical Trial Regulation.         ..
£30.00
Getting to grips with serious breach reporting: a new CTR requirement
Getting to grips with serious breach reporting: a new CTR requirement Wednesday February 16th, 20..
£100.00
European Clinical Trial Regulation No. 536/2014 (A5)
A uniquely indexed reproduction of the European Clinical Trial Regulation 2014  No. 536 as pub..
£17.50
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