CRED Understanding Clinical Development 2024

09/10/2024

DSURs

Periodicity

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• First DSUR starts with the development International birthdate – ie date of the sponsor’s first authorization to conduct a trial in any country worldwide • Report submitted annually within 60 days of data lock point

Submission

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• Member states where trial with the product is active*

• Ethics committees approving a protocol with the product

* CT regulation allows submission though EMA portal

FDA

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• Also accepts a DSUR or an IND periodic report

Japan

•

•

Accept a DSUR.

The Organisation for Professionals in Regulatory Affairs

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Other requirements Europe

Individual trial management • End of trial declaration and summary of findings required to be submitted within one year of end of trial • If trial is interrupted or stopped for safety issues submission of reasons to regulators within 15 days with summary of safety findings • Sponsors allowed to make urgent safety changes to trial protocol without approval of regulators but regulators should be informed within three days and supporting data submitted

The Organisation for Professionals in Regulatory Affairs

20

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