SD1339: Missing EPOCH value when a start or observation date is provided

Pinnacle 21 Support SDTM
1

We have some historical records in finding domains as they collected for historical comparison before trial start like weight of the subject. These assessments have the DTC before the informed consent date. How to populate the EPOCH for these records, as we can not exclude. P21 firing the Warning for rule SD1339. What is the best option. I have two options

  1. DTC<RFICDT assign them as ‘Screening’. example RFICDTC = 2024-02-15, xxDTC = 2017-10-15
  2. Leave it Blank and Explain in cSDRG.
    Please share your thoughts or alternative options
2

Hi Pvasa,

Thank you for reporting this issue!

It’s known problem. We have already modified SD1339 rule. Its new version will be available in the new engine releases (Sep.?). Until that, your only option is to document P21 validation findings in SDRG.

Here is a summary of our changes:

  • SD1339 rule was split to handle Events/Interventions (SD1339) and Findings (new SD1477) separately
  • New algorithms look only to observations after RFICDTC

Kind Regards,
Sergiy

1 Like
3

Thank you very much.

4

Same Issue occurred when partial date presented in domain, so how to handle this scenario for partial date also…

Please Suggest..

5

Hi,

Could you provide more details? Engine, sample values with partial dates?

These rules are expected to work only in case of full dates in dataset.

Thanks,
Sergiy