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SD0009 - No qualifiers set to 'Y', when AE is Serious - Origin?
FDA requirement
I believe this comes from FDACLIN-0195. Serigy presented this rule as an example during the OpenCDISC Live event at Novartis last week.
Hi! SD0009 check came from
Hi!
SD0009 check came from ICH 2A and ICH E6.
Kind Regards,
Sergiy
FDACLIN-0195, ICH 2A and ICH E6
Thanks mdigian and Sergiy. We are pretty new to all this. Have you got a link for either of those? When I Google the 1st one it just brings me back to my comment...
http://www.ich.org/fileadmin/
http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf
All ICH Guindances: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
Also note that when serious
Also note that when serious (SER = Y), there are 8 CDISC options for which one must be checked, but only 5 are ICH compliant. Futhermore all values including AESER are bound to CDISC CT code C66742 (Yes/No) codelist.
Predicate | Concept | variable | ICH |
Results in | Death | __SDTH |
|
Results in | Life threat | __SLIFE |
|
Results in | Disability | __SDISAB |
|
Results in | Hospitalization | __SHOSP |
|
Associated with | Congenitgal Anomaly/Birth Defect | __SCONG |
|
Associated with | Cancer | __SCAN | No |
Occurred From | Overdose | __SOD | No |
unknown | Other Serious Medically Important Event | __SMIE | No |
Related Records
The reason a qualifier should be checked is because a reviewer may want to quickly understand at a high level why the sponsor indicated the AE was serious. The next obvious step is if any one of those 8 boxes are checked, it would be good to create a RELREC that links this Serious AE to the concept which qualifies it seriousness.
For example if the AE occurred from overdose, you may want to link to the Conmed (CM) or Exposure (EX) records which contained the overdose. If it was associated with a Congenital Anomoly or Birth defect, perhaps a link to the patients Medical History (MH). If it resulted in death, it should link back to another record in AE and possibly Disposition. Anything resulting in diability or hospitaliztion might point to some custom domain recording the event or perhaps Findings About (FA).
Reasons for seriousness fields
Thanks both!
I'm a bit confused now, because I am thinking from the perspective of data collection, and CDASH 1.1 says this:
If the details regarding a Serious AE should be collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. In many cases sponsors will only collect the AESER field because the individual serious adverse event types might be collected in a separate pharmacovigilance database and therefore do not need to be collected in the clinical database.
The second sentence represents pretty normal practice for us! Adding all the reasons for seriousness would add a burden of 8 data collection fields in the CRF, and duplicate information already collected by PV. Are we expected to merge PV data with CRF data to produce SDTM? Or is including the fields merely "recommended"?
I hope all this isn't going beyond the remit of the forum! I think you're doing a great job in interpreting the great faceless morass of CDISC for us on the ground, so it's very tempting to be lazy and just ask questions.
Hi, I've been trying to validate a test database and I've just come across the rule SD0009: "No qualifiers set to 'Y', when AE is Serious".
I'm using SDTM IG 3.1.3 and I can't find this referenced there - can someone tell me where it comes from? And whether it's mandatory or just recommended, as the qualifiers are not something we'd normally collect? (It gives a Warning rather than an Error.)
Thanks!