1777 Sentry Parkway West
Building 17, Suite 405
Blue Bell, PA 19422
+1 (888) 507-2270
SD1203 / PPDTC
Hi Brian, It's a good catch!
Hi Brian,
It's a good catch! We will remove SD1203 assignment from PP domain,
Thanks,
Sergiy
It looks like the the same…
It looks like the the same issue still exists in latest version 3.0.0 of validator.
SergiySD1203 rule was revised by FDA and applied by all FINDINGS
Hi Igor,
SD1203 rule was revised by FDA and as FDAB034 was applied to all INTERVENTIONS, EVENTS, FINDINGS, DM, SE and SV domains.
Kind Regards,
Sergiy
SD1203 rule
The background of this error being thrown is that the SDTM team abused "PPDTC" for something that is not a "datetime of collection" (that is what "--DTC" is standing for). The SDTMIG 3.2 states for PPDTC: "Nominal date/time of parameter calculations".
"Calculations" is something else that "collection". Calculations may indeed have been performed AFTER the end of the participation, especially as (also according to the IG): "PP: Pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data", indicating that PP calculations can have been done after the PC dataset was generated, which can very well be ways after the subject ended participation in the study.
Best solutions is that the FDA makes a clear statement that the SD1203 rule does not apply to PP.
With best regards,
Jozef Aerts
XML4Pharma
SergiyMy suggestion would be to remove PPDTC variable
Hi Igor,
My suggestion would be to remove PPDTC variable from your dataset. It is Permissible variable which stores Data Management tracking information not relevant to analysis and rarely included into submission datasets. I've heard that CDISC team even considered to remove PPDTC variable in SDTM IG 3.3. However, it is still there.
Why do you need it?
Kind Regards,
Sergiy
Hi,
I ran OpenCDISC 1.5 on some SDTM data we received from a CRO, and SD1203 popped up since PPDTC was after RFPENDTC. I don't usually see PPDTC populated, but it seems they were strictly following the IG where this is "Date/Time of Parameter Calculations", which I assume was the date on which the PP calculations were done by the PK group.
Should SD1203 apply to PPDTC, as it seems plausible to have these calculations done after the subject ends participation in the study?
Thanks,
Brian