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 |
---|
|
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?] |
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.
Dataset wrap |
---|
|
Rowcaps |
---|
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. |
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | PTSEQ | PTREFID | SPTOBID | PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTTSTCND | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTSPCCND | PTMETHOD | PTLLOQ | PTREPNUM | PTTPT | PTTPTNUM |
---|
1 | TOB07 | PT | | VAP77777.1 | 111 | 54-11-5 | NIC | Nicotine | STABILITY STUDY |
| E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 2 | TOB07 | PT | 2 | VAP77777.1 | 111 | 54-11-5 | NIC | Nicotine | STABILITY STUDY |
| E-Liquid Standard (Long Term) Condition |
|
|
|
|
| AEROSOL |
|
|
| 1 | Week 0 | 1 | 3 | TOB07 | PT | 3 | VAP77777.1 | 111 | 494-97-3 | XXXXX | | STABILITY STUDY | Nicotine Degradant | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 4 | TOB07 | PT | 4 | VAP77777.1 | 111 | 494-52-0 | XXXXX | | STABILITY STUDY | Nicotine Degradant | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 5 | TOB07 | PT | 5 | VAP77777.1 | 111 | 56-81-5 | XXXXX | Glycerin | STABILITY STUDY | Primary Ingredient | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 6 | TOB07 | PT | 6 | VAP77777.1 | 111 | 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 | 7 | VAP77777.1 | 111 | 65-85-0 | XXXXX | Benzoic Acid | STABILITY STUDY | Acid | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 8 | TOB07 | PT | 8 | VAP77777.1 | 111 | 89-78-1
confirm this one, there are two - the other is 1490-04-6 | XXXXX | Menthol | STABILITY STUDY | Flavorant | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 9 | TOB07 | PT | 9 | VAP77777.1 | 111 |
| XXXXX | Vanillin | STABILITY STUDY | Flavorant | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 10 | TOB07 | PT | 10 | VAP77777.1 | 111 | 64091-91-4 | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | HPHC | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 11 | TOB07 | PT | 11 | VAP77777.1 | 111 | 80508-23-2 | NNN | N-nitrosonornicotine | STABILITY STUDY | HPHC | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 12 | TOB07 | PT | 12 | VAP77777.1 | 111 | 64091-91-4 | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | HPHC | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| AEROSOL |
|
|
| 1 | Week 0 | 1 | 13 | TOB07 | PT | 13 | VAP77777.1 | 111 | 80508-23-2 | NNN | N-nitrosonornicotine | STABILITY STUDY | HPHC | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| AEROSOL |
|
|
| 1 | Week 0 | 1 | 14 | TOB07 | PT | 14 | VAP77777.1 | 111 |
| XXXXX | Metals - Nickel | STABILITY STUDY | Extractables / Leachables | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 15 | TOB07 | PT | 15 | VAP77777.1 | 111 |
| PH | pH | STABILITY STUDY |
| E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 16 | TOB07 | PT | 16 | VAP77777.1 | 111 |
| XXXXX | Endotoxin | STABILITY STUDY | Toxins | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 17 | TOB07 | PT | 17 | VAP77777.1 | 111 |
| XXXXX | TAMC | STABILITY STUDY | Microbiological | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 18 | TOB07 | PT | 18 | VAP77777.1 | 111 |
| XXXXX | TYMC | STABILITY STUDY | Microbiological | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 19 | TOB07 | PT | 19 | VAP77777.1 | 111 | 75-07-0 | XXXXX | Acetaldehyde | STABILITY STUDY | Aldehyde | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 | 20 | TOB07 | PT | 20 | VAP77777.1 | 111 |
| XXXXX | Acetyl propionyl | STABILITY STUDY | Diketone | E-Liquid Standard (Long Term) Condition |
|
|
|
|
| E-LIQUID |
|
|
| 1 | Week 0 | 1 |
|
|
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.
Dataset wrap |
---|
|
Rowcaps |
---|
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. |
|
Dataset2 |
---|
Row | | DOMAIN | PTSEQ | PTREFID | PTGRPID | PTTESTCD | PTTEST | PTTSTCND | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTSPCCND | PTMETHOD | PTREPNUM | PTTPT | PTTPTNUM |
---|
1 | TOB07 | PT | 211 | VAP77777.1 | 1 | NIC | | E-Liquid Standard (Long Term) Condition |
| mg/mL |
|
| mg/mL | E-LIQUID |
|
| 1 | Week 0 | 1 | 2 | TOB07 | PT | 212 | VAP77777.1 | 1 | | Nicotine | E-Liquid Standard (Long Term) Condition |
| mg/mL |
|
| mg/mL | E-LIQUID |
|
| 2 | Week 0 | 1 | 3 | TOB07 | PT | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 220 | VAP77777.1 | 3 | NIC | | E-Vapor Standard Aerosol Condition |
| mg/puff |
|
| mg/puff | AEROSOL |
|
| 1 | Week 0 | 1 | 11 | TOB07 | PT | 221 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
|
| mg/puff | AEROSOL |
|
| 2 | Week 0 | 1 | 12 | TOB07 | PT | 222 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
|
| mg/puff | AEROSOL |
|
| 3 | Week 0 | 1 | 13 | TOB07 | PT | 223 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
|
| mg/puff | AEROSOL |
|
| 1 | Week 24 | 4 | 14 | TOB07 | PT | 224 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
|
| mg/puff | AEROSOL |
|
| 2 | Week 24 | 4 | 15 | TOB07 | PT | 225 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
|
| mg/puff | AEROSOL |
|
| 3 | Week 24 | 4 | 16 | TOB07 | PT | 226 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
|
| mg/puff | AEROSOL |
|
| 1 | Week 52 | 9 | 17 | TOB07 | PT | 227 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
|
| mg/puff | AEROSOL |
|
| 2 | Week 52 | 9 | 18 | TOB07 | PT | 228 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
|
| mg/puff | AEROSOL |
|
| 3 | Week 52 | 9 | 19 | TOB07 | PT | 229 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
|
| mg/puff | AEROSOL |
|
| 1 | Week 0 | 1 | 20 | TOB07 | PT | 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 |
|
|
The Trial Test Lookup (TL) 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 TLVAR1="PTTSTCND" and TLVRVAL1="E-Liquid Standard (Long Term) Condition" identifies the specific testing regimen shown in PTTSTCND as the focus of the testing regimen parameters listed in TLPARMCD/TLPAM. TLVAL and TVALU 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 TLVALU which was not originally part of the TL draft domain. May propose elevating this structure to a "Trial Lookup" observational class, within which some domains would allow for TLVALU)
Dataset wrap |
---|
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | RDOMAIN | TLVAR1 | TLVRVAL1 | TLSEQ | TLGRPID | TLPARMCD | TLPARM | TLVAL | TLVALU |
---|
1 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 1 |
| PUFFPROF | Puff Profile | SQUARE |
| 2 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 2 |
| PUFFDUR | Puff Duration | 1.25 | sec | 3 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 3 |
| PUFFINT | Puff Interval | 3 | PUFF/min | 4 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 4 |
| PUFFBLCK | Puff Block | 25 | % | 5 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 5 |
| NUMPUFF | Total Number of Puffs | 200 | PUFF | 6 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 6 |
| PUFFVOL | Puff Volume | 10 | mL | 7 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 7 |
| PUFFRNG | Puff Range | 100-200 |
| 8 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 8 | 1 | PUFFPAUS | Puff Pause | 60 | s | 9 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 9 | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF |
|
|
TO BE ARCHIVED; NOT FOR REVIEW. 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. Values of PTTSTCND used in any PT dataset can be described in the TC dataset.
The example below shows the attributes of one testing regimen shown in the PT stability study above.
Dataset wrap |
---|
|
Rowcaps |
---|
Rows 1-9: | Show the attributes of the testing regimen identified in PTTSTCND="E-Vapor Standard Aerosol Condition". The value of this variable is taken directly from the value of PTTSTCND in the PT dataset from the stability study. | Rows 8-9: | Show the puff pause duration and the puff pause interval. Taken together, these two records show that the regimen calls for a 60 second pause every 10 puffs. |
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | PTTSTCND | TCSEQ | TCPARMCD | TCPARM | TCVAL | TCVALU |
---|
1 | TOB07 | TC | E-Vapor Standard Aerosol Condition | 1 | PUFFPROF | | SQUARE |
| 2 | TOB07 | TC | E-Vapor Standard Aerosol Condition | 2 | PUFFDUR | Puff Duration | 1.25 | sec | 2 | TOB07 | TC | E-Vapor Standard Aerosol Condition | 3 | PUFFINT | Puff Interval | 3 | PUFF/min | 4 | TOB07 | TC | E-Vapor Standard Aerosol Condition | 4 | PUFFBLCK | Puff Block | 25 | % | 5 | TOB07 | TC | E-Vapor Standard Aerosol Condition | 5 | NUMPUFF | Total Number of Puffs | 200 | PUFF | 6 | TOB07 | TC | E-Vapor Standard Aerosol Condition | 6 | PUFFVOL | Puff Volume | 10 | mL | 7 | TOB07 | TC | E-Vapor Standard Aerosol Condition | 7 | PUFFRNG | Puff Range | 100-200 |
| 8 | TOB07 | TC | E-Vapor Standard Aerosol Condition | 8 | PUFFPAUS | Puff Pause | 60 | s | 9 | TOB07 | TC | E-Vapor Standard Aerosol Condition | 9 | PUFFPINT | Puff Pause Interval | 10 | PUFF |
|
|