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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.


Question: For laboratory's limit of detection (LOD), limit of quantification (LOQ); Should we have --ORNRLO = Reference Range Lower Limit in Orig Unit; and --ORNRHI = Reference Range Upper Limit in Orig Unit?  There is a variable --LLOD = Lower Limit of Detection. Added this for LOD. What should be used for LOQ? Thanks.

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 PTSCAT variable. The E-Liquid substance has the condition represented using the PTTSTCND which is Condition 1.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSPDEVIDSTOCONDIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PT111
Condition 1

1

VAP77777.1NICOTINENicotineSTABILITY STUDY
35.94mg/g
35.9435.94mg/gE-LIQUID


1Week 01
2TOB07PT111
Condition 12VAP77777.1NICOTINENicotineSTABILITY STUDY

0.1039

mg/PUFF
0.10390.1039mg/PUFFAEROSOL


1Week 01
3TOB07PT111
Condition 13VAP77777.1NORNCTN

Nornicotine

STABILITY STUDYNicotine Degradant25.76ug/g
25.7625.76ug/gE-LIQUID


1Week 01
4TOB07PT111
Condition 13VAP77777.1NORNCTN

Nornicotine

STABILITY STUDYNicotine Degradant0.0392ug/PUFF
0.03920.0392ug/PUFFAEROSOL


1Week 01
5TOB07PT111
Condition 15VAP77777.1GLYCRLGlycerolSTABILITY STUDYPrimary Ingredient615.68mg/g
615.68615.68mg/gE-LIQUID


1Week 01
6TOB07PT111
Condition 15VAP77777.1GLYCRLGlycerolSTABILITY STUDYPrimary Ingredient1.81mg/PUFF0.001441.811.81mg/PUFFAEROSOL


1Week 01
7TOB07PT111
Condition 16VAP77777.1PRPYLGLYPropylene GlycolSTABILITY STUDYPrimary Ingredient218.21mg/g
218.21218.21mg/gE-LIQUID


1Week 01
8TOB07PT111
Condition 16VAP77777.1PRPYLGLYPropylene GlycolSTABILITY STUDYPrimary Ingredient0.8565mg/PUFF0.000240.85650.8565mg/PUFFAEROSOL


1Week 01
9TOB07PT111
Condition 17VAP77777.1BNZOICACBenzoic AcidSTABILITY STUDYAcid





E-LIQUID


1Week 01
10TOB07PT111
Condition 18VAP77777.1MENTHOLMentholSTABILITY STUDYFlavorant37.53mg/g
37.5337.53mg/gE-LIQUID


1Week 01
11TOB07PT111
Condition 18VAP77777.1MENTHOLMentholSTABILITY STUDYFlavorant0.5881mg/PUFF0.000240.58810.5881mg/PUFF

AEROSOL




1Week 01
12TOB07PT111
Condition 1
VAP77777.1GLYCDOLGlycidolSTABILITY STUDYStabilizer<Limit of Detection (LOD)
0.00011<Limit of detection (LOD)

AEROSOL




1Week 01
13TOB07PT111
Condition 1
VAP77777.1FRMLDHDFormaldehydeSTABILITY STUDY
0.0728ug/PUFF0.005490.07280.0728ug/PUFF

AEROSOL




1Week 01
14TOB07PT111
Condition 1
VAP77777.1ACROLNAcrolienSTABILITY STUDY
<Limit of Quantification (LOQ)
0.00928Limit of Quantification (LOQ)

AEROSOL




1Week 01
15TOB07PT111
Condition 1
VAP77777.1LACTICACLactic AcidSTABILITY STUDY
40.44ug/g
40.4440.44ug/g

E-LIQUID




1Week 01
16TOB07PT111
Condition 1
VAP77777.1LACTICACLactic AcidSTABILITY STUDY
29.71ug/PUFF0.28429.7129.71ug/PUFF

AEROSOL




1Week 01
17TOB07PT111
Condition 19VAP77777.1VANLLNVanillinSTABILITY STUDYFlavorant1.12ug/g
1.121.12ug/gE-LIQUID


1Week 01
18TOB07PT111
Condition 110VAP77777.1NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDYHPHC0.0711ug/g
0.07110.0711ug/gE-LIQUID


1Week 01
19TOB07PT111
Condition 111VAP77777.1NNNN-NitrosonornicotineSTABILITY STUDYHPHC0.0852ug/g
0.08520.0852ug/gE-LIQUID


1Week 01
20TOB07PT111
Condition 112VAP77777.1NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDYHPHC0.0577ug/PUFF
0.05770.0577ug/PUFFAEROSOL


1Week 01
21TOB07PT111
Condition 113VAP77777.1NNNN-NitrosonornicotineSTABILITY STUDYHPHC0.0742ug/PUFF
0.07420.0742ug/PUFFAEROSOL


1Week 01
22TOB07PT111
Condition 114VAP77777.1NICKELNickelSTABILITY STUDYExtractables / Leachables 0.0897ug/g
0.08970.0897ug/gE-LIQUID


1Week 01
23TOB07PT111
Condition 114VAP77777.1MASSMassSTABILITY STUDY
3.87mg/PUFF0.00713.873.87mg/PUFFAEROSOL


1Week 01
24TOB07PT111
Condition 114VAP77777.1CHROMIUMChromiumSTABILITY STUDY
NOT DETECTED

NOT DETECTED

E-LIQUID


1Week 01
25TOB07PT111
Condition 115VAP77777.1PHpHSTABILITY STUDY
7.15

7.157.15
E-LIQUID


1Week 01
26TOB07PT111
Condition 115VAP77777.1PHpHSTABILITY STUDY
7.24

7.247.24
AEROSOL


1Week 01
27TOB07PT111
Condition 116VAP77777.1ENDTXNEndotoxinSTABILITY STUDYToxins





E-LIQUID


1Week 01
28TOB07PT111
Condition 117VAP77777.1AEBPLCTAerobic Plate CountSTABILITY STUDYMicrobiological<1 CFU/mL
<1 <1 CFU/mLE-LIQUID


1Week 01
29TOB07PT111
Condition 118VAP77777.1TYMCTotal Yeast and/or Mold CountSTABILITY STUDYMicrobiological1CFU/mL
11CFU/mLE-LIQUID


1Week 01
30TOB07PT111
Condition 119VAP77777.1ACTALDAcetaldehydeSTABILITY STUDYAldehyde





E-LIQUID


1Week 01
31TOB07PT111
Condition 120VAP77777.1ACTPROPNAcetyl PropionylSTABILITY STUDYDiketone





E-LIQUID


1Week 01

Dataset Debug Messages

  • There are four leading, trailing, or non-breaking spaces in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

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 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

DOMAINSPTOBIDSTOCONIDPTSEQPTREFIDPTGRPIDPTTESTCDPTTESTPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTREPNUMPTTPTPTTPTNUM
1TOB07PT111Condition 1211VAP77777.11NICOTINE

Nicotine

35.94mg/g35.9435.94mg/gE-LIQUID

1Week 01
2TOB07PT111Condition 1212VAP77777.11

NICOTINE

Nicotine35.46mg/g35.4635.46mg/gE-LIQUID

2Week 01
3TOB07PT111Condition 1213VAP77777.11NICOTINENicotine35.97mg/g35.9735.97mg/gE-LIQUID

3Week 01
4TOB07PT111Condition 1214VAP77777.11NICOTINENicotine35.55mg/g35.5535.55mg/gE-LIQUID

1Week 244
5TOB07PT111Condition 1215VAP77777.11NICOTINENicotine35.88mg/g35.8835.88mg/gE-LIQUID

2Week 244
6TOB07PT111Condition 1216VAP77777.11NICOTINENicotine35.67mg/g35.6735.67mg/gE-LIQUID

3Week 244
7TOB07PT111Condition 1217VAP77777.11NICOTINENicotine36.11mg/g36.1136.11mg/gE-LIQUID

1Week 529
8TOB07PT111Condition 1218VAP77777.11NICOTINENicotine35.72mg/g35.7235.72mg/gE-LIQUID

2Week 529
9TOB07PT111Condition 1219VAP77777.11NICOTINENicotine35.54mg/g35.5435.54mg/gE-LIQUID

3Week 529
10TOB07PT111Condition 2220VAP77777.13NICOTINE

Nicotine

0.1039mg/PUFF0.10390.1039mg/puffAEROSOL

1Week 01
11TOB07PT111Condition 2221VAP77777.13NICOTINENicotine0.1142mg/PUFF0.11420.1142mg/puffAEROSOL

2Week 01
12TOB07PT111Condition 2222VAP77777.13NICOTINENicotine0.1282mg/PUFF0.12820.1282mg/puffAEROSOL

3Week 01
13TOB07PT111Condition 2223VAP77777.13NICOTINENicotine0.1242mg/PUFF0.12420.1242mg/puffAEROSOL

1Week 244
14TOB07PT111Condition 2224VAP77777.13NICOTINENicotine0.1084mg/PUFF0.10840.1084mg/puffAEROSOL

2Week 244
15TOB07PT111Condition 2225VAP77777.13NICOTINENicotine0.1174mg/PUFF0.11740.1174mg/puffAEROSOL

3Week 244
16TOB07PT111Condition 2226VAP77777.13NICOTINENicotine0.1374mg/PUFF0.13740.1374mg/puffAEROSOL

1Week 529
17TOB07PT111Condition 2227VAP77777.13NICOTINENicotine0.1364mg/PUFF0.13640.1364mg/puffAEROSOL

2Week 529
18TOB07PT111Condition 2228VAP77777.13NICOTINENicotine0.1264mg/PUFF0.12640.1264mg/puffAEROSOL

3Week 529
19TOB07PT111Condition 2229VAP77777.13NICOTINENicotine0.1256mg/PUFF0.12560.1256mg/puffAEROSOL

1Week 01
20TOB07PT111Condition 3230VAP77777.14NICOTINENicotine0.1236mg/PUFF0.12360.1236mg/puffAEROSOL

2Week 01
21TOB07PT111Condition 3231VAP77777.14NICOTINENicotine0.1126mg/PUFF0.11260.1126mg/puffAEROSOL

3Week 01
22TOB07PT111Condition 3232VAP77777.14NICOTINENicotine0.1334mg/PUFF0.13340.1334mg/puffAEROSOL

1Week 244
23TOB07PT111Condition 3233VAP77777.14NICOTINENicotine0.1134mg/PUFF0.11340.1134mg/puffAEROSOL

2Week 244
24TOB07PT111Condition 3234VAP77777.14NICOTINENicotine0.1125mg/PUFF0.11250.1125mg/puffAEROSOL

3Week 244
25TOB07PT111Condition 3235VAP77777.14NICOTINENicotine0.1156mg/PUFF0.11560.1156mg/puffAEROSOL

1Week 529
26TOB07PT111Condition 3236VAP77777.14NICOTINENicotine0.1145mg/PUFF0.11450.1145mg/puffAEROSOL

2Week 529
27TOB07PT111Condition 3237VAP77777.14NICOTINENicotine0.1157mg/PUFF0.11570.1157mg/puffAEROSOL

3Week 529
$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.

es.xpt

es.xpt

RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11HUMIDHumidity37%
2

TOB07

ESCondition 12TEMPTemperature24C
3

TOB07

ESCondition 21HUMIDHumidity60%
4

TOB07

ESCondition 22TEMPTemperature27C
5

TOB07

ESCondition 31HUMIDHumidity95%
6

TOB07

ESCondition 32TEMPTemperature31C
$warningHtml

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