SDTM

As for SDTM (–ENTPT), how should we define a reference time point? Is there a specify rule about these variables. Likes AEENTPT.

SDTM  IG 3.4 section 4.4.7 says “The variables --STRTPT and --ENRTPT contain values similar to --STRF and --ENRF, but may be anchored with any timing description or date/time value expressed in the respective --STTPT and --ENTPT variables, and are not limited to the study reference period.”

Hi Team,

Can we have a space in-between in STUDYID / USUBJID values? We don't have any specific restriction for providing with respect to spacing for STUDYID, USUBJID variables in IG.

Example: STUDYID = ABCSTDY-A 101  ;   USUBJID = ABCSTDY-A 101-001-101

Hi there,

I have a study with data collected with duplicated information. Is it mandatory to include all of the collected data in SDTM different domains even if they are duplicated?  

I added AETRTEM variable of which label is Treatment Emergent Flag in SUPPAE as per FDA rule.

However , still see the 'No Treatment Emergent info for Adverse Event' error after validation using FDA engine. 

Is it possible not to see this error?

I'm getting error SD1079 for the MHEVDTYP variable using the 3.3 (FDA) community version of P21. 

The SDTM Model 2.0 lists the correct order as:  STUDYID, DOMAIN, USUBJID, MHSEQ, MHSPID, MHTERM, MHLLT, MHLLTCD, MHDECOD, MHEVDTYP, MHPTCD, MHHLT, MHHLTCD, MHHLGT, MHHLGTCD, MHCAT, MHBODSYS, MHBDSYCD, MHSOC, MHSOCCD, EPOCH,  MHSTDTC, MHENDTC, MHSTDY, MHENDY, MHENRTPT, MHENTPT.

But this is order is giving the SD1079 error.  Any suggestions?

Thank you

The planned dose frequency(BID) and actual dose frequency(QD) are different. How to represent this record in the EC domain? 

As per protocol , Eligibility criteria confirmation is done at V1 (screening) and at V2(Day1 of treatment epoch, before randomization.)

In case Eligibility criteria was all met at V1, but not met at V2 so that ends in Screening Failure, 

Can I assign epoch as 'SCREENING' to V2 while Randomized Patients are assigned as 'TREATMENT' at V2?

I mean, Doesn't  Visit and Epoch have to match 1:1?

Please help me to get assurance. 

When the Inclusion/Exclusion criteria do not change, but a new one is inserted in a subsequent version, the criteria number has been identified by adding a suffix to the IETESTCD.

TIVERS=Version 1

IETESTCD=EXCL01

IETEST=Ongoing infection

TIVERS=Version 2

IETESTCD=EXCL01A

IETEST=Patients with melanoma

IETESTCD=EXCL02A

IETEST=Ongoing infection

Pinnacle 21 however gives the following message for the EXCL02A record, since the same IETEST now has two different IETESTCD.

Hi there,

Is there a time schedule for when Pinnacle21 plans to support SDTM IG 3.3 validation under NMPA engine?

Thank you!

zg