THIS EXAMPLE IS UNDER RE-CONSTRUCTION FOLLOWING THE TEAM CALL ON 17 JAN. See also example in the "sandbox' here, which demonstrates the current approach reviewed on that call.
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 (PT) 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 Condition 1.
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 Condition 1.
pt.xpt
pt.xpt
Row
STUDYID
DOMAIN
SPTOBID
SPDEVID
STOCONDID
PTSEQ
PTREFID
PTCAS
PTTESTCD
PTTEST
PTCAT
PTSCAT
PTORRES
PTORRESU
PTSTRESC
PTSTRESN
PTSTRESU
PTSPEC
PTSPCCND
PTMETHOD
PTLLOQ
PTREPNUM
PTTPT
PTTPTNUM
1
TOB07
PT
111
Condition 1
1
VAP77777.1
54-11-5
NIC
Nicotine
STABILITY STUDY
E-LIQUID
1
Week 0
1
2
TOB07
PT
111
Condition 1
2
VAP77777.1
54-11-5
NIC
Nicotine
STABILITY STUDY
AEROSOL
1
Week 0
1
3
TOB07
PT
111
Condition 1
3
VAP77777.1
494-97-3
NORNCTN
Nornicotine
STABILITY STUDY
Nicotine Degradant
E-LIQUID
1
Week 0
1
4
TOB07
PT
111
Condition 1
4
VAP77777.1
494-52-0
ANABASN
Anabasine
STABILITY STUDY
Nicotine Degradant
E-LIQUID
1
Week 0
1
5
TOB07
PT
111
Condition 1
5
VAP77777.1
56-81-5
GLYCRL
Glycerol
STABILITY STUDY
Primary Ingredient
E-LIQUID
1
Week 0
1
6
TOB07
PT
111
Condition 1
6
VAP77777.1
57-55-6
PRPYLGLY
Propylene Glycol
STABILITY STUDY
Primary Ingredient
E-LIQUID
1
Week 0
1
7
TOB07
PT
111
Condition 1
7
VAP77777.1
65-85-0
XXXXX
Benzoic Acid
STABILITY STUDY
Acid
E-LIQUID
1
Week 0
1
8
TOB07
PT
111
Condition 1
8
VAP77777.1
89-78-1
confirm this one, there are two - the other is 1490-04-6
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 Condition 1 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 Condition 2 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 Condition 3 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
STOCONID
PTSEQ
PTREFID
PTGRPID
PTTESTCD
PTTEST
PTORRES
PTORRESU
PTSTRESC
PTSTRESN
PTSTRESU
PTSPEC
PTSPCCND
PTMETHOD
PTREPNUM
PTTPT
PTTPTNUM
1
TOB07
PT
111
Condition 1
211
VAP77777.1
1
NIC
Nicotine
mg/mL
mg/mL
E-LIQUID
1
Week 0
1
2
TOB07
PT
111
Condition 1
212
VAP77777.1
1
NIC
Nicotine
mg/mL
mg/mL
E-LIQUID
2
Week 0
1
3
TOB07
PT
111
Condition 1
213
VAP77777.1
1
NIC
Nicotine
mg/mL
mg/mL
E-LIQUID
3
Week 0
1
4
TOB07
PT
111
Condition 1
214
VAP77777.1
1
NIC
Nicotine
mg/mL
mg/mL
E-LIQUID
1
Week 24
4
5
TOB07
PT
111
Condition 1
215
VAP77777.1
1
NIC
Nicotine
mg/mL
mg/mL
E-LIQUID
2
Week 24
4
6
TOB07
PT
111
Condition 1
216
VAP77777.1
1
NIC
Nicotine
mg/mL
mg/mL
E-LIQUID
3
Week 24
4
7
TOB07
PT
111
Condition 1
217
VAP77777.1
1
NIC
Nicotine
mg/mL
mg/mL
E-LIQUID
1
Week 52
9
8
TOB07
PT
111
Condition 1
218
VAP77777.1
1
NIC
Nicotine
mg/mL
mg/mL
E-LIQUID
2
Week 52
9
9
TOB07
PT
111
Condition 1
219
VAP77777.1
1
NIC
Nicotine
mg/mL
mg/mL
E-LIQUID
3
Week 52
9
10
TOB07
PT
111
Condition 2
220
VAP77777.1
3
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
1
Week 0
1
11
TOB07
PT
111
Condition 2
221
VAP77777.1
3
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
2
Week 0
1
12
TOB07
PT
111
Condition 2
222
VAP77777.1
3
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
3
Week 0
1
13
TOB07
PT
111
Condition 2
223
VAP77777.1
3
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
1
Week 24
4
14
TOB07
PT
111
Condition 2
224
VAP77777.1
3
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
2
Week 24
4
15
TOB07
PT
111
Condition 2
225
VAP77777.1
3
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
3
Week 24
4
16
TOB07
PT
111
Condition 2
226
VAP77777.1
3
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
1
Week 52
9
17
TOB07
PT
111
Condition 2
227
VAP77777.1
3
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
2
Week 52
9
18
TOB07
PT
111
Condition 2
228
VAP77777.1
3
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
3
Week 52
9
19
TOB07
PT
111
Condition 2
229
VAP77777.1
3
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
1
Week 0
1
20
TOB07
PT
111
Condition 3
230
VAP77777.1
4
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
2
Week 0
1
21
TOB07
PT
111
Condition 3
231
VAP77777.1
4
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
3
Week 0
1
22
TOB07
PT
111
Condition 3
232
VAP77777.1
4
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
1
Week 24
4
23
TOB07
PT
111
Condition 3
233
VAP77777.1
4
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
2
Week 24
4
24
TOB07
PT
111
Condition 3
234
VAP77777.1
4
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
3
Week 24
4
25
TOB07
PT
111
Condition 3
235
VAP77777.1
4
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
1
Week 52
9
26
TOB07
PT
111
Condition 3
236
VAP77777.1
4
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
2
Week 52
9
27
TOB07
PT
111
Condition 3
237
VAP77777.1
4
NIC
Nicotine
mg/puff
mg/puff
AEROSOL
3
Week 52
9
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset. The variable STOCONID/Storage Condition ID represents the storage condition. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.