Impact of EMA Clinical Trial Regulation EU 536/2014 for documents and information to be included in Clinical Trial Information System (CTIS)

10:40 AM - 11:25 AM

During the last couple of months, clinical trial sponsors have been facing the challenges of the mandatory use of CTIS for submission of Clinical Trials Applications (CTA) in EU in accordance with the EMA Clinical Trials Regulation EU 536/2014. Hopefully many sponsors have gained some experience during 2022 with use of the system during the year, when CTIS was available for voluntary use.

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 to remember in relation to document and information preparation will be reviewed from the sponsor’s view. Furthermore, 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.

Living up to the General Data Protection Regulation (GDPR)/EU Data Protection Regulation is also a responsibility that calls for special attention. Other topic that will be presented include the content of the Joint Data Controller Arrangement and the responsibility placed on the clinical trial sponsor in relation to documents being uploaded into CTIS both for processes leading to document versions for ‘regulatory review’ and the public view i.e., ‘for publication’. Which options are available for protection of Private Personal Data (PPD) and when are PPD to be included also for the public versions and when are they definitely not allowed to be available for disclosure.