Reporting Modifications to Clinical Trials under the Clinical Trials Regulation (CTR)

Modifications to trials that are submitted via CTIS are made in CTIS. The below is adapted from the sponsor guide on EudraLex Vol 10. See the link collection to the right to read more about the difference between substantial and non-substantial modifications under CTR.

Modifications to trials under CTR rules must be submitted via CTIS.

A distinction is made between:

  • Substantial Modifications (SMs). A 'substantial modification' is defined in CTR Article 2 (13) as 'any change to an aspect of the clinical trial made after the notification of a decision referred to in Article 8, 14, 19, 20 or 23 which may have a substantial impact on the safety or rights of the subject or on the reliability or robustness of the data generated in the clinical trial'. This includes adding a new trial site or changing a principal investigator at a trial site. Significant amendments to a clinical trial must always be notified and approved before they are implemented.
  • Amendments covered by Article 81.9. These are amendments that are not substantial amendments (SMs), but are nevertheless relevant for the Member State's supervision of clinical trials.
  • Non-substantial Modifications (NSMs) that do not require authorization or notification.

Annex IV of the Q&A - CTR provides an overview of the different types of changes that require either authorization or notification. See also section 3 of the Q&A - CTR and the sponsor guide on EudraLex Vol 10. See also the link collection.

At the time the amendment to the trial is submitted, there must not be any other applications regarding the trial under assessment in Denmark.

Last updated 01-02-2024

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