SDTM

Hello, 

I kept getting label warnings on a number of variables in the TS domain which I believe were correct per the SDTM IG  v 3.2.  I may be missing something but these are the ones I had issues with that I've solved - modified the labels to what P21 suggested, but feel a little queesy about changing my labels from the IG just to make the warnings go away.  

CRF is collecting following info on Medical History form at screening:

Has the participant taken HIV medication for pre-exposure prophylaxis (PrEP) against HIV in the past 14 days?

For how many days was PrEP taken?

Is the participant currently on PrEP?

Can you tell me which is best domain for this data (CM or RP)? How would we model this data in SDTM domains?

Thanks in Advance!

Hi All,

Sorry to ask this question - I did check the existing content but could not find a similar question.

Anyway, in August, we ran community version 2.2 (FDA validation rules) on our data and received the following error:

'RACE value not found in 'Race' non-extensible codelist' (Pinnacle 21 ID = CT2001, Publisher ID = FDAC340)

Latest CT for SDTM released on 2019-06-28, however the cdm.xml file is not available in the downloads.

Dear colleagues, dear SDTM experts,

I have trouble understanding the difference (and their implementation in P21) between rules SD1228 and rule CT2004.

Rule SD1228: "Variable should be populated with terms from its CDISC controlled terminology codelist, when its value level condition is met. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms."

Hi,

We are mapping genomic data for a client and the genomic data is from a vendor.

I have the following questions:

1. If we use any of the PGx domains to map the genomic data (in any of the BE, PF, PB, BS, PG, SB domains), we get Pinnacle errors.

2. Does Pinnacle Community version not support PGx domains?

3. Since the SDTM datasets have to go through Pinnacle validation, what should be done for validating PGx domains?

4. Do we instead need to map PGx to other custom domains or map the PGx domains to LB domain?

Thanks,

I am puzzled about the FDA rule "SE0009 - Missing values for both --DTC and --DY variables".
According to the Excel worksheet published by the FDA, the rule applies to both SDTM and SEND, but it does not seem to be listed in Pinnacle21 SDTM validation reports.
Was this forgotten or is there an error in the FDA Excel and is it only applicable to SEND?

Rule SD2237 states "ACTARM does not equal ARM", and "A value for an Actual Arm (ACTARM) variable is expected to be equal to a value of an Arm (ARM) variable",
but the FDA technical conformance Guide March 2019 states:
"For subjects who are randomized in treatment group but not treated, the planned arm variables (ARM and ARMCD) should be populated, but actual treatment arm variables (ACTARM and ACTARMCD) should be left blank".

I am using the variable MITSTDTL (Microscopic Examination Detail) to indicate differences between STAINING INTENSITY and STAINING EXTENSIVENESS. However, this variable is not included when evaluating for duplicate records in Pinnacle and therefore warning messages are generating. Should MITSTDTL not to included here?

Why is pinnacle generating an error message for MH events that start before rfstdtc, but have an endtc during the study? This doesnt make sense to me since ongoing  is acceptable.