SD1118 Warnings

Pinnacle 21 Support SDTM
1

Hi William,

There are several well-known deficiencies in current data standards due to a conflict between general scientific principles vs. particular practical needs.

Lack of standardization in Disposition data is one of examples. DS is some sort of “generic” domain. It was developed to handle all possible Study Disposition data and all possible cases.

Yes, Disposition Event Start Date may be not applicable sometimes. However this information is heavily used by FDA reviewers to estimate drug Efficacy and Safety as well as general Data Quality. E.g.,

  • Time of subject participation is the study is a common assessment for Drug Efficacy and Safety.
  • Subject Survival Status is usually collected in DS domain.
  • Date of last contact with subject is expected to be collected in DS domain and be used for data management cross-reference checks.

There are many standard reports based on DSSTDTC variable. Independent reviewers (e.g., FDA) will try to analyze your Disposition timing info regardless of your company common data collection practice.

Regards,

Sergiy

2

We have recently been getting warnings when running OpenCDISC validator for Rule ID SD1118, with a message ‘Neither DSSTDTC nor DSSTDY are populated’. The warnings are occurring on data entered into a form in our eCRF library. The form is designed in such a way that a date is only completed under certain circumstances and dependant on replies to other questions on the form. Our internal groups have confirmed a date being recorded on the current form for every subject would not be required for any of our analysis or reporting. The DSSTDTC item is Expected in the SDTM IG, meaning variables may contain some null values. The DSSTDY item is permissible. Therefore, I am not sure why this is being flagged as a warning, and am not clear what risk there is for us if this situation persists when we use this standard form. Could somebody please clarify if I am missing something, and/or what risk is associated with these warnings persisting each time we run the validator? Many thanks.