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May 17, 2023

Considerations For Compliance With CTIS Submissions Under The EU-CTR

By Michael J. Halaiko, JD, CIPP/E, Alexandra P. Moylan, JD, CIPP/US

Life Science Leader

In an article published on May 1, 2023 in Life Science Leader, Mike Halaiko and Alexandra Moylan provide guidance for clinical trial submissions within the European Economic Area (EEA) which are required to be submitted through the Clinical Trial Information System (CTIS) as of January 1, 2023.

“The implementation of CTIS presents potential advantages and challenges for sponsors of clinical trials within the EEA. Having a single access point for submissions regarding clinical trials performed in the EEA should generally prove beneficial for sponsors. However, the level of transparency of the information submitted through CTIS is new under EU-CTR, requiring sponsors to develop and refine an internal framework to ensure compliance with the allowed redaction of commercially confidential information (CCI) and the mandatory redaction of protected personal data (PPD) in CTIS submissions.

Life Science Leader subscribers can access the full article here.