Clinical Trial Start Up – Sponsor perspective

11:00 AM - 11:50 AM

Clinical Trial Start Up – Sponsor perspective
Overview and impact of new requirements, disclosure documents, deferrals, redactions, timelines; updated SOPs, Trainings – of sponsor internal and external stakeholders

Merete Jorgensen (Merete J Consulting) 

Clinical trial sponsors are facing challenges of the mandatory use of CTIS for submission of Clinical Trial Applications (CTA) in the EU in accordance with the EMA Clinical Trials Regulation (EU) No 536/2014 (CTR).

The submission has/had and will in future have implications for documents and information submitted as part of the clinical trial process from the CTA submission through to the clinical trial completion and even after the drug approval application process. Some key topics on what is involved and what to remember in relation to document preparation will be reviewed from the clinical trial sponsor’s view. Internal preparedness for new or updated processes (such as SOPs, trainings, information dissemination) will be highlighted. Important topics as to how to protect Commercially Confidential Information (CCI) by use of information minimisation, deferral options and/or redaction of sensitive information will also be discussed. 

Interface of the General Data Protection Regulation (GDPR)/EU Data Protection Regulation with CTR is also a topic of special consideration – especially with regard to the responsibilities of the study sponsor to protect certain Private Personal Data (PPD).

EU CTR Considerations for Authoring Clinical Regulatory Documents

Paula Nixon (Astra Zeneca) 

The European Union (EU) pharmaceutical legislation known as the EU Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure high standards of public transparency and safety for clinical trial participants and is impacting many aspects of medical writing. This presentation will go through some of the considerations we have worked through in planning, authoring, and redacting our study documents at the Sponsor side.