Versions Compared

Old Version 3

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version Current

changes.mady.by.user Lorraine Sobson

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

An ADaM-compliant ADSL dataset and its related metadata are required in a CDISC-based submission of data from a clinical trial study even if no other ADaM datasets are submitted. The structure of the ADSL is 1 record per subject, regardless of the type of clinical trial design.study design. The label of the ADSL dataset is "Subject-Level Analysis Dataset." In a study, there is only 1 dataset in the class "SUBJECT LEVEL ANALYSIS DATASET", and its name is ADSL. Any other datasets with 1 record per subject would be members of other classes (e.g., the BDS, "ADAM OTHER" class).

This section lists standard ADSL variables. Within a given study, USUBJID is the key variable that links the ADSL to other datasets (both SDTM and ADaM).

...

One possible solution includes the creation of a "pre-ADSL" dataset that is used as input into subsequent analysis datasets. The final ADSL is created and collates variables as needed from any analysis dataset including the pre-ADSL dataset. If this process is employed, the pre-ADSL dataset should follow ADaM principles but may not contain all required ADSL variables.

Pagenav