Sylvia Lobo Dr

There does not seem to be a keyword search for this forum... if that is correct, can we please have one.  If not, how do I search using terms?
 

A variation was submitted and as a result of review, not all changes will be accepted.   The scope and present/proposed section will therefore be different to what was submitted.  The eAF is supposed to be updated to align with the variation  outcome for the closing sequence.  The guidance mentions using a clone option so as not to lose the submitted form which is showing as draft.

1.  Should I use the clone option and then amend the relevant sections?
2.  If I do (1) what how should the initial "draft" form be managed?
3. Is it possible on a submitted application form which is still in draft to amend in that instead?

Thanks 
 

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?