This example will need to be updated following recent developments and consultation with CDISC ISMT. Current examples illustrating this approach can be found in the Sandbox here.
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.
The example shown below is not an all inclusive comprehensive example. It is meant to be illustrative of the concepts.
Shelf life study has a protocol and provides the results of shelf life studies of Vapes 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 Vapes products for one testing condition at one timepoint and one replicate.
Tobacco Product Testing (TT) is a Findings domain similar to the Laboratory Test Results domain.
PTCAS variable (in place of the LBLOINC variable) provides the accurate chemical name, structure for organic and inorganic substances.
Rows 1-20:
Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is E-Liquid Standard (Long Term) Condition.
Rows 2, 12, 13:
Show the Nicotine, 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK), and N-nitrosonornicotine analytes in the Aerosol substance represented using the PTSPEC variable.
Rows 17, 18:
Show microbials, TAMC and TYMC (PTTEST and PTTESTCD), used in testing (aerobic plate count, mold, and yeast) using the PTCAT variable. The E-Liquid substance has the condition represented using the PTTSTCND which is E-Liquid Standard (Long Term) Condition.
pt.xpt
pt.xpt
Row
STUDYID
DOMAIN
SPTOBID
PTSEQ
PTREFID
PTCAS
PTTESTCD
PTTEST
PTCAT
PTSCAT
PTTSTCND
PTORRES
PTORRESU
PTSTRESC
PTSTRESN
PTSTRESU
PTMATRIX
PTSPCCND
PTMETHOD
PTLLOQ
PTREPNUM
PTTPT
PTTPTNUM
1
TOB07
PT
111
1
VAP77777.1
54-11-5
NIC
Nicotine
STABILITY STUDY
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
2
TOB07
PT
111
2
VAP77777.1
54-11-5
NIC
Nicotine
STABILITY STUDY
E-Liquid Standard (Long Term) Condition
AEROSOL
1
Week 0
1
3
TOB07
PT
111
3
VAP77777.1
494-97-3
XXXXX
Nornicotine
STABILITY STUDY
Nicotine Degradant
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
4
TOB07
PT
111
4
VAP77777.1
494-52-0
XXXXX
Anabasine
STABILITY STUDY
Nicotine Degradant
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
5
TOB07
PT
111
5
VAP77777.1
56-81-5
XXXXX
Glycerin
STABILITY STUDY
Primary Ingredient
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
6
TOB07
PT
111
6
VAP77777.1
57-55-6
XXXXX
Propylene Glycol
STABILITY STUDY
Primary Ingredient
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
7
TOB07
PT
111
7
VAP77777.1
65-85-0
XXXXX
Benzoic Acid
STABILITY STUDY
Acid
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
8
TOB07
PT
111
8
VAP77777.1
89-78-1
confirm this one, there are two - the other is 1490-04-6
There is a leading, trailing, or non-breaking space in the dataset.
Please remove all paragraph and/or line breaks.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
A Shelf Life study dataset would shows analytes done in different test conditions with replicates over time points. In the interest of brevity for this example, only portions of the content using the TEST of Nicotine is shown in a sample of timepoints in two conditions with replicates. The weeks reflective of Week 1, Week 2, Week 3, etc. which would align with the PTTPTNUM of 2,3, etc. are not shown for visual viewing purposes. This is an example, this provides possible tests that might be used to demonstrate how to use the datasets and variables to show what was done for the shelf-life stability study. It shows what timepoint and what type of data follows. It is important to show different test conditions for each analyte. For aerosol a machine similutaion is use so mg/puff is valid.
Rows 1-9:
Show the PTTEST of Nicotine for E-Liquid Standard (Long Term) Condition which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for Nicotine 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 10-19:
Show the PTTEST of Nicotine for E-Vapor Standard Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.
Rows 20-27:
Show the PTTEST of Nicotine for E-Vapor Intense Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.
pt.xpt
pt.xpt
Row
STUDYID
DOMAIN
SPTOBID
PTSEQ
PTREFID
PTGRPID
PTTESTCD
PTTEST
PTTSTCND
PTORRES
PTORRESU
PTSTRESC
PTSTRESN
PTSTRESU
PTSPEC
PTSPCCND
PTMETHOD
PTREPNUM
PTTPT
PTTPTNUM
1
TOB07
PT
111
211
VAP77777.1
1
NIC
Nicotine
E-Liquid Standard (Long Term) Condition
mg/mL
mg/mL
E-LIQUID
1
Week 0
1
2
TOB07
PT
111
212
VAP77777.1
1
NIC
Nicotine
E-Liquid Standard (Long Term) Condition
mg/mL
mg/mL
E-LIQUID
2
Week 0
1
3
TOB07
PT
111
213
VAP77777.1
1
NIC
Nicotine
E-Liquid Standard (Long Term) Condition
mg/mL
mg/mL
E-LIQUID
3
Week 0
1
4
TOB07
PT
111
214
VAP77777.1
1
NIC
Nicotine
E-Liquid Standard (Long Term) Condition
mg/mL
mg/mL
E-LIQUID
1
Week 24
4
5
TOB07
PT
111
215
VAP77777.1
1
NIC
Nicotine
E-Liquid Standard (Long Term) Condition
mg/mL
mg/mL
E-LIQUID
2
Week 24
4
6
TOB07
PT
111
216
VAP77777.1
1
NIC
Nicotine
E-Liquid Standard (Long Term) Condition
mg/mL
mg/mL
E-LIQUID
3
Week 24
4
7
TOB07
PT
111
217
VAP77777.1
1
NIC
Nicotine
E-Liquid Standard (Long Term) Condition
mg/mL
mg/mL
E-LIQUID
1
Week 52
9
8
TOB07
PT
111
218
VAP77777.1
1
NIC
Nicotine
E-Liquid Standard (Long Term) Condition
mg/mL
mg/mL
E-LIQUID
2
Week 52
9
9
TOB07
PT
111
219
VAP77777.1
1
NIC
Nicotine
E-Liquid Standard (Long Term) Condition
mg/mL
mg/mL
E-LIQUID
3
Week 52
9
10
TOB07
PT
111
220
VAP77777.1
3
NIC
Nicotine
E-Vapor Standard Aerosol Condition
mg/puff
mg/puff
AEROSOL
1
Week 0
1
11
TOB07
PT
111
221
VAP77777.1
3
NIC
Nicotine
E-Vapor Standard Aerosol Condition
mg/puff
mg/puff
AEROSOL
2
Week 0
1
12
TOB07
PT
111
222
VAP77777.1
3
NIC
Nicotine
E-Vapor Standard Aerosol Condition
mg/puff
mg/puff
AEROSOL
3
Week 0
1
13
TOB07
PT
111
223
VAP77777.1
3
NIC
Nicotine
E-Vapor Standard Aerosol Condition
mg/puff
mg/puff
AEROSOL
1
Week 24
4
14
TOB07
PT
111
224
VAP77777.1
3
NIC
Nicotine
E-Vapor Standard Aerosol Condition
mg/puff
mg/puff
AEROSOL
2
Week 24
4
15
TOB07
PT
111
225
VAP77777.1
3
NIC
Nicotine
E-Vapor Standard Aerosol Condition
mg/puff
mg/puff
AEROSOL
3
Week 24
4
16
TOB07
PT
111
226
VAP77777.1
3
NIC
Nicotine
E-Vapor Standard Aerosol Condition
mg/puff
mg/puff
AEROSOL
1
Week 52
9
17
TOB07
PT
111
227
VAP77777.1
3
NIC
Nicotine
E-Vapor Standard Aerosol Condition
mg/puff
mg/puff
AEROSOL
2
Week 52
9
18
TOB07
PT
111
228
VAP77777.1
3
NIC
Nicotine
E-Vapor Standard Aerosol Condition
mg/puff
mg/puff
AEROSOL
3
Week 52
9
19
TOB07
PT
111
229
VAP77777.1
3
NIC
Nicotine
E-Vapor Standard Aerosol Condition
mg/puff
mg/puff
AEROSOL
1
Week 0
1
20
TOB07
PT
111
230
VAP77777.1
4
NIC
Nicotine
E-Vapor Intense Aerosol Condition
mg/puff
mg/puff
AEROSOL
2
Week 0
1
21
TOB07
PT
231
VAP77777.1
4
NIC
Nicotine
E-Vapor Intense Aerosol Condition
mg/puff
mg/puff
AEROSOL
3
Week 0
1
22
TOB07
PT
232
VAP77777.1
4
NIC
Nicotine
E-Vapor Intense Aerosol Condition
mg/puff
mg/puff
AEROSOL
1
Week 24
4
23
TOB07
PT
233
VAP77777.1
4
NIC
Nicotine
E-Vapor Intense Aerosol Condition
mg/puff
mg/puff
AEROSOL
2
Week 24
4
24
TOB07
PT
234
VAP77777.1
4
NIC
Nicotine
E-Vapor Intense Aerosol Condition
mg/puff
mg/puff
AEROSOL
3
Week 24
4
25
TOB07
PT
235
VAP77777.1
4
NIC
Nicotine
E-Vapor Intense Aerosol Condition
mg/puff
mg/puff
AEROSOL
1
Week 52
9
26
TOB07
PT
236
VAP77777.1
4
NIC
Nicotine
E-Vapor Intense Aerosol Condition
mg/puff
mg/puff
AEROSOL
2
Week 52
9
27
TOB07
PT
237
VAP77777.1
4
NIC
Nicotine
E-Vapor Intense Aerosol Condition
mg/puff
mg/puff
AEROSOL
3
Week 52
9
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The Test Conditions (TC) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable in a PT dataset.
The example below shows the attributes of the testing regimen identified as PTTSTCND="E-Liquid Standard Aerosol Condition" (see e-liquid stability study pt.xpt example). Note that the combination of TCVAR1="PTTSTCND" and TCVRVAL1="E-Liquid Standard (Long Term) Condition" identifies the specific testing regimen shown in PTTSTCND as the focus of the testing regimen parameters listed in TCPARMCD/TCPARM. TCVAL and TCVALU show the specific values and units (respectively, where applicable) for the given parameter.one testing regimen shown in the PT stability study above. (We've added TCVALU which was not originally part of the TC draft domain. May propose elevating this structure to a "Trial Lookup" observational class, within which some domains would allow for TCVALU)