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.