m Manolya
on

 

Hi!

On purpose I found out that I have a case where AESTDTC is before Informed Consent was signed. This study is a legacy study, so the DB is closed since 8 years.

The rule SD1204 (AEENDTC after RFPENDTC) exists, but for the case above there is no warning/error. Is that correct?

 

Thanks!

 

Forums: SDTM

j Jozef
on June 17, 2015

Looks as you have a data quality error ...
How can one have an AE before informed consent was signed? Medication should normally not have started before the informed consent was signed, so either it is not an AE or you have a heavy protocol violation ...
Better document this in your reviewers guide ...

m Manolya
on June 18, 2015

Indeed, this is a data issue. This will go into the RG, of course. It is listed as an AE before first Treatment.

But still I would expect the cdisc checker to give me an error in such a case.

Thank you!

j Jozef
on June 18, 2015

Does the SDTM-IG actually state that this is a rule?

If not, than it is not a rule, and we should not invent new ones.

For your own company, you can of course always add such a "company-specific rule".
After all, OpenCDISC is open source.

P.S. You should not use the term "CDISC Checker", that is something else ...

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