The EU Clinical Trial Regulation Virtual Course

The EU Clinical Trial Regulation.

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.

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This virtual course consists of two 2-hour webinars.
It will be interactive and involve presentations, workbook tasks, discussion, poll questions and participants Q&A.

Part 1: “Overview and implementation of the CTR”

•          Current EU legislation.
•          The need for a Regulation.
•          When the CTR can be implemented.
•          Current situation and likely ‘go-live’ date.
•          Structure of the CTR and supporting guidelines.
•          Interventional, non-interventional and low interventional trials.
•          Authorization of a clinical trial – a single application.
•          Notifications required.
•          The application flow chart and timescales.
•          Substantial and non-substantial modifications.
•          Conditions for conducting a clinical trial.
•          Site suitability statement.
•          Investigator’s Brochure updates.
•          Additional informed consent requirements.
•          Consent for vulnerable patients.
•          Compensation.
•          Withdrawal of consent.
•          Safety reporting.
•          Serious breach reporting.
•          Urgent safety measures.
•          Summary of trial results.
•          Trial Master File and document retention.

Participants Q&A.

Participants will be asked to do some preparation for Part 2 based on a workbook to be provided.

 

Part 2: “CTR guidelines, harmonisation templates, Q&As and implementation considerations”

•          The Clinical Trial Information System (CTIS) – what is it?
•          Functionality of the CTIS.
•          CTIS training and user requirements.
•          Transparency and publicly accessible information.
•          Sponsor workspace and applications.
•          Harmonisation guidance and templates.
• Compensation for trial participants template.
• Investigator Curriculum Vitae template.
• Declaration of interest template.
• Site suitability form.
• Informed consent and patient recruitment procedure template.
•          GMP and Regulations of IMP and Auxiliary Medicinal Products.
•          Summaries of Clinical Trial Results for Laypersons.
•          Ethical considerations for clinical trials on medicinal products conducted with minors.

·         Questions and Answers Document - Regulation (EU) 536/2014 – your chance to decide on a course of action (workbook and discussion)

The interplay between the Clinical Trials Regulation and the General Data Protection Regulation (GDPR).

·         Other guidelines to note – brief mentions of the other guidelines that need to be considered.

• Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - EMEA/CHMP/SWP/28367/07 Rev. 1 (July 2017).
• Risk proportionate approaches in clinical trials (April 2017).
• Detailed guidelines on good clinical practice specific to advanced therapy medicinal products.
• Recommendation on the content of the trial master file and archiving.

Key points for implementing the CTR - sponsors and investigators.

Participants Q&A.

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