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Different EudraCT Numbers



  • Christine
    15/08/2015 19:24
    Protocol and amendments have different EudraCT numbers: This is a bioavailability study, phase 1 using healthy subjects. This is what I have found: Protocol version 1 = (September 2013) EudraCT number : Not applicable (sponsor address was in the US). Protocol amendment 1 (Substantial amendment) : = (January 2014) same sponsor (now giving the UK address) Eudract number: 2013-11111111 (not using real numbers for anonymity) Protocol amendment 2 (March 2014) EudraCT number 2014 - 8888888 (different number to protocol amendment 1) First subject first visit: June 2014. The protocol title is the same, and same IND Number throughout. My question is: when are EudraCT numbers allowed to change for the same study, as I thought the number should not be changed? The final clinical study report EudraCT number corresponds with the amendment 1 protocol, ( i.e. 2013-11111111) but not with Amendment 2 or the first protocol (first protocol Eudract number being N/A). Thanks in anticipation.
  • GPvP Committee
    02/11/2015 16:55
    It would not be routinely expected that the EudraCT number would change for an amendment. A single EudraCT number is provided by study and it is the link to the sponsor protocol number. However, a consideration could be whether the Protocol amendment changed to the extent that a regulatory authority would consider it as a new study? It is recommended that you follow up with EMA to discuss the differences in EUDRACT numbers.
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