Spring Intro 2023

16/02/2023

What should I do on getting Approval?

Submission to Agencies, Questions & Approval

Compilation, Publishing, Review

Strategic Planning & Submission Document Development

● Communicate to colleagues

– Verbal vs. “in writing” – communication to the team

– Core study team including QP & Safety collegues

– Translation of approval before communication?

● Archive CTA documents

– Capture any commitments

● Reflect

– Lessons learned for next CTA

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CTA Maintenance

Protocol amendment

DSUR*

Global End of Trial

Initial Application

New CMC information (IMPD update)

Protocol amendment &

Local End of Trial**

Clinical Study Report Synopsis

add new countries

Any change to a study requires assessment by the sponsor ● Does the change have an impact on the safety of the subjects, the conduct of the trial or to the interpretation of the scientific documents ? Is there a change in the quality of the IMP? If yes, this is considered a substantial change therefore needs regulatory approval ● Typo errors, clarification of previously submitted information are considered non-substantial therefore do not need regulatory approval ● National requirements need to be considered - Adding / deleting Sites / Investigators.

*DSUR = Development Safety Update Report ** Local End of Trial submission may not be required (dependent on National Legislation)

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