Submitting more than 1 ADSL

l Lisa

on January 3, 2023

I have a situation in which we have an ADSL for an ISE. We want to also use the same ISE data but add some Natural History population flags and new analysis parameters. Would be okay to add these population flags to a dataset called ADSLNH that contains the core variables in ADSL plus the new Natural History population flags? It would be subject-level-dataset. So, I'm not sure if it will throw a P21 error for having 2 subject-level-datasets.

Any advice is helpful,

Lisa

Forums: General Discussion

Sergiy

on January 12, 2023

P21

Hi Lisa, It is not clear…

Hi Lisa,

It is not clear why do you need additional ADSL dataset? In ADaM model you can add any additional variables you need for analysis. So, why just adding Natural History population Flag and other variables does not work?

Kind Regards,
Sergiy

s Suzy

on November 27, 2024

Hi-- I realize this post is…

Hi--

I realize this post is nearly 2 years old, but I have a similar situation.

After a very large deliverable, we have been asked to rederive an ADSL flag variable that affects a handful of outputs. Because all of our ADaMs contain all of the ADSL variables, our options were:

1. Update ADSL; re-QC; rerun all other ADaMs; re-QC; rerun all outputs; re-QC. Days worth of work for our small team.

2. Create ADSL2 with the updated variable, and use this only in the programs for the relevant outputs. Maybe a half day's work.

I can't presume to know the OP's situation, but this is the reason why I now have two ADSLs. I have been asked (for eSub) to drop the original ADSL, rename the updated ADSL2 to ADSL, and submit that to P21. My concern (I have posted this separately) is, does P21 compare the value of VAR1 in ADSL against the value in the other ADaMs? If so, it would be easier to submit both ADSLs (if this is possible).