I've been in contact with Virginia @VirginiaChiocchia regarding the DMC report preparation.
The DMC like to specifically see SAEs separated from AEs.
The current exports that Virginia can make to not include the variables needed to make this distinction.
Would it be possible to add the following so that Serious adverse events (defined by YES to any of the six questions mentioned in #155) can be flagged easier, so:
serious_eligible_1 (django.db.models.BooleanField) – “AE10 lead to death”
serious_eligible_2 (django.db.models.BooleanField) – “AE11 life threatening illness”
serious_eligible_3 (django.db.models.BooleanField) – “AE12 permanent impairment”
serious_eligible_4 (django.db.models.BooleanField) – “AE13 hospitalisation”
serious_eligible_5 (django.db.models.BooleanField) – “AE14 prolonged hospitalisation”
serious_eligible_6 (django.db.models.BooleanField) – “AE15 surgery required”
Hi Carl @marshalc
I've been in contact with Virginia @VirginiaChiocchia regarding the DMC report preparation. The DMC like to specifically see SAEs separated from AEs. The current exports that Virginia can make to not include the variables needed to make this distinction.
Would it be possible to add the following so that Serious adverse events (defined by YES to any of the six questions mentioned in #155) can be flagged easier, so:
serious_eligible_1 (django.db.models.BooleanField) – “AE10 lead to death” serious_eligible_2 (django.db.models.BooleanField) – “AE11 life threatening illness” serious_eligible_3 (django.db.models.BooleanField) – “AE12 permanent impairment” serious_eligible_4 (django.db.models.BooleanField) – “AE13 hospitalisation” serious_eligible_5 (django.db.models.BooleanField) – “AE14 prolonged hospitalisation” serious_eligible_6 (django.db.models.BooleanField) – “AE15 surgery required”
Would be an enormous help and timesaver.
Thanks