This two 1.5 hour session course overviews the key changes brought about by the new Regulation, and considers some of the practical aspects of conducting clinical trials in accordance with the CTR.

Participants require no previous knowledge or experience of the CTR. It is most suitable for those operationally involved in clinical trial design, management and oversight, including those in clinical operations, data management, regulatory affairs and quality assurance.

The course will be interactive and involve presentations, workbook tasks, discussion, poll questions and participants Q&A.

It may be presented as two sessions in a single day with a suitable break in between, or as two sessions each on a different day.

A guide to course content is shown below, which may vary in order to keep up-to-date with changes and developments.

• Legal basis and status of the CTR and its interplay with other legislation.
• The Clinical Trial Information System (CTIS)
• Structure of the CTR and supporting guidelines.
• Interventional, non-interventional and low interventional trials.
• Authorization of a clinical trial – a single electronic application.
• Notifications required by the CTR.
• Substantial and non-substantial modifications.
• Conditions for conducting a clinical trial, important new requirements.
• Site suitability statement.
• Investigator’s Brochure updates.
• Additional informed consent requirements.
• Consent for vulnerable patients.
• Compensation.
• Withdrawal of consent.
• Safety reporting.
• The CTR and trial medication.
• Serious breach reporting.
• Urgent safety measures.
• Summary of trial results.
• Trial Master File and document retention.
• Transparency and publicly accessible information.
• Practical aspects, use of the given templates
• The CTR Q&A document; reportable non-substantial amendments.
• Defining the start and end of recruitment.
• Impact on the trial investigator.