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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.
The resulting structure would require 648 rows to illustrate the 12 analytes shown in the example study we received, done in triplicate under two test conditions at the number of timepoints in the example 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.

Info
titleTobacco domains

DI = TO for Tobacco Product Identifiers and Descriptors

SPDEVID = SPTOBID for Sponsor Tobacco Product Identifier

DO/DU = Tobacco Product Design Parameters (PD)

LB = Tobacco Product Testing (PT) - [Would Findings be better?]

Shelf life study has a protocol and provides the results of shelf life studies of tobacco products over time with different conditions and analytes.  Generally there are many conditions with at least two with varying temperature, humidity, etc.

The initial table shows the a number of the analytes and test conditions used in Shelf Life studies for smokeless tobacco products for one testing condition at one timepoint and one replicate. The second table has one analyte and two test conditions for many time points and replicates.


The Tobacco Product Testing (PT) is a Findings domain similar to the Laboratory Test Results domain.

...

Dataset wrap
Namept
Rowcaps
Rows 1-9:Show the PTTEST of Product Moisture for Condition 1 which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for product moisture is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint.  The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test.
Rows 10-18:Show the PTTEST of Product Moisture for Condition 2 across the same timepoints shown for Condition 1.  The PTGRPID is used to tie together a block of related records in a single domain.
Dataset2
RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTREFIDPTTESTCDPTTESTPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTREPNUMPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 1111TOB77777.1PRODMSTProduct Moisture51.93%51.9351.93%TOBACCOADD theseas is
1Week 01
2TOB07PTSmokeless01Condition 1112TOB77777.1PRODMSTProduct Moisture51.96%51.9651.96%TOBACCOas is
2Week 01
3TOB07PTSmokeless01Condition 1113TOB77777.1PRODMSTProduct Moisture51.98%51.9851.98%TOBACCOas is
3Week 01
4TOB07PTSmokeless01Condition 1114TOB77777.1PRODMSTProduct Moisture51.75%51.7551.75%TOBACCOas is
1Week 84
5TOB07PTSmokeless01Condition 1115TOB77777.1PRODMSTProduct Moisture51.75%51.7551.75%TOBACCOas is
2Week 84
6TOB07PTSmokeless01Condition 1116TOB77777.1PRODMSTProduct Moisture51.67%51.6751.67%TOBACCOas is
3Week 84
7TOB07PTSmokeless01Condition 1117TOB77777.1PRODMSTProduct Moisture52.05%52.0552.05%TOBACCOas is
1Week 489
8TOB07PTSmokeless01Condition 1118TOB77777.1PRODMSTProduct Moisture52.68%52.6852.68%TOBACCOas is
2Week 489
9TOB07PTSmokeless01Condition 1119TOB77777.1PRODMSTProduct Moisture52.21%52.2152.21%TOBACCOas is
3Week 489
10TOB07PTSmokeless01Condition 2120TOB77777.1PRODMSTProduct Moisture51.93%51.9351.93%TOBACCOas is
1Week 01
11TOB07PTSmokeless01Condition 2121TOB77777.1PRODMSTProduct Moisture51.96%51.9651.96%TOBACCOas is
2Week 01
12TOB07PTSmokeless01Condition 2122TOB77777.1PRODMSTProduct Moisture51.98%51.9851.98%TOBACCOas is
3Week 01
13TOB07PTSmokeless01Condition 2123TOB77777.1PRODMSTProduct Moisture51.80%51.8051.80%TOBACCOas is
1Week 84
14TOB07PTSmokeless01Condition 2124TOB77777.1PRODMSTProduct Moisture51.77%51.7751.77%TOBACCOas is
2Week 84
15TOB07PTSmokeless01Condition 2125TOB77777.1PRODMSTProduct Moisture51.84%51.8451.84%TOBACCOas is
3Week 84
16TOB07PTSmokeless01Condition 2126TOB77777.1PRODMSTProduct Moisture52.18%52.1852.18%TOBACCOas is
1Week 489
17TOB07PTSmokeless01Condition 2127TOB77777.1PRODMSTProduct Moisture52.21%52.2152.21%TOBACCOas is
2Week 489
18TOB07PTSmokeless01Condition 2128TOB77777.1PRODMSTProduct Moisture51.87%51.8751.87%TOBACCOas is
3Week 489


Finally, the The storage conditions details of "E-Liquid Standard (Long Term) Condition 1" and "E-Liquid Standard (Long Term) Condition 1" .Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset.

  • The variable STOCONID (Storage Condition ID) = "E-Liquid Standard (Long Term) Condition". Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.These values were made up, but we assume they'd look something like this.


Dataset wrap
Namees
Dataset2
RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESE-Liquid Standard (Long Term) Condition 11HUMIDHumidity37%
2

TOB07

ESE-Liquid Standard (Long Term) Condition 12TEMPTemperature24C
3

TOB07

ESE-Liquid Standard (Long Term) Condition 21HUMIDHumidity85%
4

TOB07

ESE-Liquid Standard (Long Term) Condition 22TEMPTemperature27C