Posted Thu, 27 Jun 2024 08:04:13 GMT by Benedicte Perret
Is there any recommendation on Key Element recording when the length seems limited to 88 characters while the Key Element description (e.g. Study design features, Main ojectives and study population is far longer than 88 characters in the Decision with annexes? There is not limitation specified in the KE guidance posted on EMA website.
Posted Mon, 01 Jul 2024 06:23:02 GMT by Paolo Tomasi EMA
No field in the key elements is supposed to be limited to 88 characters. Please raise an incident in Report an issue with IRIS
Posted Tue, 02 Jul 2024 08:36:57 GMT by Andreea Szentannai
This issue still persists. The "Study design features, main objectives and study population" is limited to 1200 characters which is still insufficient for a proper description to be included. Would it be acceptable for EMA that we submit the Key Elements Form as a Word document? We would like to make the submission no later than tomorrow. 
Posted Mon, 15 Jul 2024 14:02:16 GMT by Paolo Tomasi EMA
Key Elements should be submitted in the IRIS platform as per current procedural guidance. 

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