We have an approved PIP under the old ex-IRIS system.
(a) It seems that IRIS is not automatically updated with what has been approved already - is that correct?
(b) If (a) is correct, then for the first modification it seems that ALL key elements for ALL studies have to be populated. Presumably the modification can be incoporated at this point rather then having to enter the current approved decision elements and then make another submission is that corect?
(c) As with Benedict, it seems that there is a character limit for study design information. However this is inconsistent. I have been able to put the full information in for Quality but not the clinical and clinical studies (not yet attempted modelling and extrapolation) - is that intentional? Moreover the guidance states to copy everything per the previous Decision...
(d) Under the old Decision for clinical studies there was a field for "plan for specific follow-up not part of completion of this study" - that is not present in Iris. Are we supposed to capture it under "other" or is that no longe required? Again this seems to be at variance with the gudiance on copying across everything previously approved.
(e) The Applicant's Comments field does not seem to be accessible - is that because although I am modifying I have nothing in Iris to modify against?
