Page History
Warning |
---|
This example will need to be updated following the ENDS stability study approach, which was created to reflect recent developments and consultation with CDISC ISMT |
Info |
---|
NOTE TO TEAM REVIEWERS: The example below demonstrates the required data structure of one record per analyte per replicate per test condition per timepoint to accurately represent data from a stability study. For conciseness, we have abbreviated the examples below to demonstrate the concepts as follows: First- we show all 12 analytes as a single replicate, at one time point and one test condition in order to illustrate the variables and terminology required to put together a stability study with assays done in replicate at different time points and varying test conditions, even though only one record per analyte is illustrated. Second- We show ONE analyte (moisture) in triplicate, over a series of time points and two test conditions to give a sense of what the complete data would look like. Hopefully users could combine the information shown in both examples to construct a complete dataset containing all the records for each analyte-replicate-test condition-time point group. |
...