SDTM

Description

Technical support questions about SDTM standard and validation rules

Rule SD0072 RELREC RDOMAIN='FACE' raises P21 Validator error

December 30, 2020
Forums

Pinnacle 21 Community Validator raises a rule SD0072 error "Related Domain Abbreviation (RDOMAIN) must have a valid value of Domains included in the study data".  

I am following the Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review use of FACE as a domain. I am also following the SDTM Vaccine TAUG v1.1, which explicitly provides an example where RDOMAIN='FACE'. A dataset face.xpt exists with DOMAIN='FACE'.

Is there anything I can do to avoid the SD0072 error and still comply with the OVRR and Vaccine TAUG guidance?

FDAC183 Missing value for CMDOSU, when CMDOSE, CMDOSTXT or CMDOSTOT is provided - CMDOSTXT = UNK?

December 21, 2020
Forums

This check is firing because our CMDOSTXT is unknown, and it is populated with "UNK". Now my question is if it is valid to populate CMDOSTXT = UNK or UNKNOWN. If so, the check does not need to fire in this case, right?

EC and EX representation for Total dose collected over a period other than day

December 8, 2020
Forums

Hi,

We currently have a scenario where the drug is dispensed to the subject for a period which patient will log in the diary and will be entered in the database during the next onsite visit.

- Planned Dose on CRF = 1 tablet every day

- Actual Dose on CRF is aggregate of drug intake during entire period of 1 month = 30 TABLETS (1 Tablet= 10 mg (protocol specified unit))

About randomized and not treated screening failure subject

November 18, 2020
Forums

Hi, 

I have a question about SDTM DM ARMCD and ARM data about below case:

The subject was mistakenly randomized but not treated study drug. And, the subject's data has been changed to  "No(screening failure)" from "Yes(screening pass)" on screening pass yes/no page.

 

Then, according to the 2020 Nov FDA TCG, if randomized subject and not treated study drug, is ARM and ARMCD assigned corresponding to the random id? Otherwise, should the ARM, ARMCD be assigned as Screen Failure, SCRNFAIL?