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At this point it’s not clear
No, your assumption is not correct. At this point it’s not clear what should be reasons for not accepting your submission data due to their poor quality or non-compliance with standards. My understanding is that FDA is working to define acceptance criteria. There is also FDA and Phuse “Data Validation” workgroup launched recently (see today’s OpenCDISC home page for details). One of its goals is to create very detailed descriptions for validation checks. Meanwhile if you have any specific questions about current rules, the OpenCDISC developers team and community will try to help you. About absolutely clean and perfect data. You should EITHER to 1. correct any valid errors/warning (fix real data/programming issues) OR 2. provide good explanation for their presence (false-positive errors, study specific stuff). Regards, Sergiy
Hello all,
Where can I find a more detailed description of the messages level as included into the validation report?
I assume that the presence of an Error in the validation report means that FDA will not accept that submission. Is this assumption correct? And what about Warnings? They must absolutely be corrected before the submission, or the dataset will be accepted by FDA even though the validator reported some Warnings?
Thank you!