To transition a multinational trial from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR), sponsors must first ensure that the documents covered by the Part I assessment common to all Member States Concerned (MSC) are harmonized across all MSC. If they are not, the sponsor must submit a major amendment to the MSCs to harmonize the documents.

To support submission planning for 2024, how long should sponsors allow for this amendment process?

NOTE: The protocol approved under the CTD must also be harmonized or at least consolidated across all MSCs.

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* 1. What do you estimate is the average time to process a major amendment to harmonize the documents and protocol of a multinational trial approved under the CTD once the amendment has been submitted to the MSCs?

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Question Title

* 2. What do you estimate is the longest time a sponsor should reasonably anticipate to process a major amendment to harmonize the documents and protocol of a multinational trial approved under the CTD once the amendment has been submitted to the MSCs?

0 Days 183 Days 365 Days
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i We adjusted the number you entered based on the slider’s scale.

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