SDTM

Hi Siergy,

We are getting “Invalid dataset name for split domain” - ERROR  which is expected as we are using FA stand alone and FACE datasets.

Seems it is expecting FAxx instead FA, however in real case it is not possible.

Even in my previous company we have the same issue where we are using FACE FAMH FAAE FACM and FA as stand alone.

The time window for the screening visits is defined as study days [-60 - -1] in the protocol. However, there are some procedures that occurred before day -60 and/or before informed consent but these observations have visit=’Screening’ in raw data. Are we allowed to derive such visits as Pre-screening in SDTM?

We used 2017-06-30 CT for a study and we wanted to validate data using pinnacle 3.0.

As it is mentioned in another link pinnacle 3.0 doesnt support CT 2017-06-30, should I not use pinnacle 3.0 and stick with the older version of pinnacle?

We wanted to follow ADAM IG 1.1, reason why we wanted to use pinnacle 3.0 for both SDTM's and ADAM's.

Please suggest!

https://www.pinnacle21.com/downloads/cdisc-terminology

Hello all,

I wonder which domain and variable to map Cycle number for a oncology trials. Or it should be not submitted.

Thank you.

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,