Re-Screening / previous screening number

Re-Screening / previous screening number

Typically a question you can also post on LinkedIn (SDTM Experts Group): https://www.linkedin.com/groups/2758697

The group has >3,000 members so...

Personally, I think this is one of the things you should discuss with your FDA representative.
Also remark that if this subject is the same person, USUBJID MUST be identical. As DM may only have one record per unique USUBJID, so how would you do this with SUPPDM? Have several records there with variables like RESCRN1, RESCRN2, ... ?

Re-Screening / previous screening number

Thanks for the answer!

So if the same subject gets rescreend twice, for example, then I'd have three entries in DM for the physically same subject. However, for the 2nd and 3rd entry (rescreen1 and rescreen2) I'd have a SUPPDM entry with the previous screening nr and an SUPPDM observation saying that the subject got rescreened (RESCRN1, RESCRN2...). So the previous screening nr of the 3rd entry would be the screening nr of the 2nd entry in the DM....And the previous screening nr of the 2nd entry would be the screening nr of the first entry in DM. This is actually not really nice, and I think one should avoid such rescreenings anyway....but now I have to deal with that.

I will also post this to the SDTM expert group of linkedIn, thanks!

Re-Screening / previous screening number

No, you would only have one record in DM for each subject. It is NOT allowed to have more than 1 record for the same subject in DM. From the SDTM-IG:
"Every subject in a study must have a subject identifier (SUBJID). In some cases a subject may participate in more than one study. To identify a subject
uniquely across all studies for all applications or submissions involving the product, a unique identifier (USUBJID) must be included in all datasets.
Subjects occasionally change sites during the course of a clinical trial. The sponsor must decide how to populate variables such as USUBJID, SUBJID
and SITEID based on their operational and analysis needs, but only one DM record should be submitted for the subject. The Supplemental Qualifiers
dataset may be used if appropriate to provide additional information."

You might however have more than 1 record for rescreened subjects in SUPPDM (if necessary at all...), each row for the parent subject in DM defining a new non-standard variable, like RESCRN1, RESCRN2, ...

Re-Screening / previous screening number

Hi!

Yes, I am aware that one subject should have only one entry in DM...

However, the problem is that this subject will be re-screened as if it was his first screening. Thus he will get another screening nr and he will undergo all screening tests again. In order to map all information I end up in having more than one entry for the "same" (physically) subject having different screening numbers. Otherwise, how can this be handled? The information gathered somehow also needs to be documented....

Best regards!

Re-Screening / previous screening number

For an FDA submission, I would strongly suggest that you keep your DM very clean, obyeing all the SDTM rules for DM.
For other information like rescreening numbers, you could make a custom domain. For screening lab results, use LB and connect your these results there to your custom domain using RELREC.
At least, that's the way I would try out ...

Re-Screening / previous screening number

Okay. What about building the SV domain. If I have one USUBJID, but four different SUBJIDs...all those visits need to be represented in SV. This would lead to duplicates in USUBJID and VISITNUM and VISIT because the same subject entered Visit 1 four times, for example.

I think the Pinnacle21 validation check SD1060 would throw me an error/warning here, right?
However, if we can explain it in the SDRG...this could be acceptable?

Re-Screening / previous screening number

You situation is very interesting, but also pretty seldom I think.

Honestly said, I have no anwer.
It only demonstrates how outdated the concepts of SDTM are and how unflexible its implementation.
Time to rethink SDTM (but the SDTM team refuses to do so).