Essential Guide to the EU Clinical Trial Regulation

Essential Guide to the EU Clinical Trial Regulation
Product Code: Essential Guide to the EU Clinical Trial Regulation
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Price: £100.00

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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.

Content includes:

•             Structure of the CTR and supporting guidelines.

•             The Clinical Trial Information System (CTIS) – what is it? Functionality of the CTIS

•             Interventional, non-interventional and low interventional trials.

•             Authorization of a clinical trial – a single application.

•             Notifications and templates.

•             Substantial and non-substantial modifications.

•             Conditions for conducting a clinical trial.

•             Site suitability statement.

•             Additional informed consent requirements.

•             Consent for vulnerable patients.

•             Safety reporting.

•             Serious breach reporting.

•             Urgent safety measures.

•             Summary of trial results.

•             Trial Master File and document retention.

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