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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 The first PT dataset shows 7 constituents/parameters, each as a single replicate (PTREPNUM=1), at 1 time point (PTTPT=Week 0 / PTTPTNUM=1) and from 1 set of storage conditions (STOCONID= Condition 1) 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.

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 tobacco products for one testing condition at one timepoint and one replicate.

...

construct an SDTM-conformant PT dataset for a stability study of a smokeless product. Some constituent names (Values of PTTESTCD/PTTEST) appear twice because their results are reported two separate ways: once for the result as tested and once where the result is expressed as dry weight basis (the latter is indicated by PTTSTDTL = DRY WEIGHT BASIS). Note that the constituent/parameter names shown do not represent an exhaustive list of the controlled terminology that will be developed to support representation of stability studies in SDTM.

Note
  • STOCONID is used to identify the storage conditions of the e-liquid product for the testing performed. Details of these conditions are represented in the ES dataset example that follows the 2 PT dataset examples. 
  • PTXFN (External File Path) is used to document the location or file name within the submission that contains the lab methodology protocol used to assay the associated constituent/parameter when such methodology is too complex for the single PTMETHOD variable.
Dataset wrap
Namettpt
Rowcaps
Row 1:

Shows the

TTTEST

PTTEST of

Product

Moisture Content, which reflects the percentage of moisture in the substance for the condition noted in

TTTSTCND which is

STOCONID (i.e., Condition 1

(X°C/ Z% RH

). 

Product

Moisture

is sometimes referred to as "Oven Volatiles"

Content is used in chemistry stability studies. For microbial stability studies, Water Activity should be used, not Moisture Content (see row 3).

Rows 4, 6, 8:Shows Show the NNK , and NNN , and TSN tests with the results from the tobacco product "as-is" using the TTSPCCND to show that the tobacco is "FRESH"as tested.
Rows 5, 7, 9:Shows Show the NNK , NNN, and TSN tests with the tobacco product as "Dry and NNN test results as dry weight basis (DWB)" using the TTSPCCND to show that the tobacco is "DRIED".. Note the use of PTTSTDTL = "DRY WEIGHT BASIS"
Rows 2-123, 8-9:

Show the other analytes

used

measured in testing

(pH, water activity, NNK, NNN, TSNA, etc

.

) using the TTTEST and TTTESTCD variables.

TTTPTNUM
Dataset2
RowSTUDYIDDOMAIN
TTSEQTTREFIDTTTESTCDTTTESTTTTSTCNDTTORRESTTORRESUTTSTRESCTTSTRESNTTSTRESUTTSPECTTSPCCNDTTMETHODTTLLOQTTREPNUMTTTPT
SPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTTSTDTLPTCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07
TT
PTSmokeless01Condition 1
TOB77777.
1
PRODMST
MOISTCTT
Product MoistureCondition 1 (X°C/ Z% RH)%%TOBACCO1
Moisture Content
STABILITY TESTING52.0%0.152.052.0%

TLT07_V1

TPT LABCOTOBACCO0.12102-01-2023Week 01
2TOB07
TT
PT
2
Smokeless01
TOB77777.
Condition 12PHpH

STABILITY TESTING8.06

8.068.06
TL009_V1TPT LABCO
Condition 1 (X°C/ Z% RH)
TOBACCO
102-01-2023Week 01
3TOB07
TT
PT
3
Smokeless01
TOB77777.
Condition 13H2OACTWater Activity
Condition 1 (X°C/ Z% RH)TOBACCO

STABILITY TESTING0.86
0.010.860.86
TLPH01_V1TPT LABCOTOBACCO0.05102-01-2023
1
Week 01
4TOB07
TT
PT
4
Smokeless01
TOB77777.
Condition 14NNK
4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)Condition 1 (X°C/ Z% RH)ng/gng/gTOBACCOFRESH1
Nicotine-Derived Nitrosamine Ketone
STABILITY TESTING1.0225ug/g0.011.02251.0225ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
5TOB07
TT
PT
5
Smokeless01
TOB77777.
Condition 15NNK
4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)Condition 1 (X°C/ Z% RH)ng/gng/gTOBACCODRIED1
Nicotine-Derived Nitrosamine KetoneDRY WEIGHT BASISSTABILITY TESTING0.4908ug/g0.010.49080.4908ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
6TOB07
TT
PT
6
Smokeless01
TOB77777.
Condition 16NNNN-
nitrosonornicotineCondition 1 (X°C/ Z% RH)ng/gng/gTOBACCOFRESH
Nitrosonornicotine
STABILITY TESTING4.4633ug/g0.014.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023
1
Week 01
7TOB07
TT
PT
7
Smokeless01
TOB77777.
Condition 17NNNN-
nitrosonornicotineCondition 1 (X°C/ Z% RH)ng/gng/gTOBACCODRIED1Week 018TOB07TT8TOB77777.1TSNATobacco-specific nitrosaminesCondition 1 (X°C/ Z% RH)ng/gng/gTOBACCOFRESH
NitrosonornicotineDRY WEIGHT BASISSTABILITY TESTING2.1424ug/g0.012.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023
1
Week 01
9
8TOB07
TT
PT
9
Smokeless01
TOB77777.
Condition 18
TSNATobacco-specific nitrosaminesCondition 1 (X°C/ Z% RH)ng/gng/gTOBACCODRIED1Week 01
AEBCTAerobic Colony Count
STABILITY TESTING154000CFU/g1154000154000CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023
10TOB07TT10TOB77777.1AEBPLCTAerobic Plate CountCondition 1 (X°C/ Z% RH)TOBACCO1
Week 01
11
9TOB07
TT
PT
11
Smokeless01
TOB77777.
Condition 1
MOLD
9
MoldCondition 1 (X°C/ Z% RH)TOBACCO1Week 01
YSTMLDCTYeast and/or Mold Colony Count
STABILITY TESTING<10CFU/g1<10
CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023
12TOB07TT12TOB77777.1YEASTYeastCondition 1 (X°C/ Z% RH)TOBACCO1
Week 01

*DWB=Dry weight basis. The DWB normalizes the results since starting moisture may vary.

...

Info

The second PT dataset shows testing for just 1 parameter (Moisture Content), performed in 3 replicates (note the values of PTREPNUM), at the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from 2 sets of storage conditions (STOCONID), in samples of both dried and as-is tobacco (PTSPEC, PTSPCCND) in order to illustrate how those variables are used to represent their associated concepts in a stability study. 

Note
  • Details of the storage conditions are represented in the ES dataset example that follows.
Dataset wrap
Namelbpt
Rowcaps
Rows 1-9:

Show the

TTTEST

results of

Product Moisture for Condition 1 (X°C/ Z% RH) which is shown in TTTSTCND. The sample of various timepoints that may be used in the testing for product moisture is reflected in TTTPT. The TTTPTNUM 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.

testing Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 1" (STOCONID). 

Rows 10-18:Show the TTTEST results of Product Moisture for Condition 2 Condition 2 (A °C/ B %RH) across the same timepoints shown for Condition 1.  The TTGRPID is used to tie together a block of related records in a single domain.testing Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 2" (STOCONID). 
Dataset2
9
RowSTUDYIDDOMAINTTSEQTTREFIDTTTESTCDTTTESTTTTSTCNDTTORRESTTORRESUTTSTRESCTTSTRESNTTSTRESUTTSPECTTSPCCNDTTMETHODTTREPNUMTTTPTSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTSPCCNDPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUMTTTPTNUM
1TOB07TTPT111Smokeless01TOB77777.Condition 1111MOISTCTTPRODMSTProduct Moisture Condition 1 (X°C/ Z% RH)%%TOBACCO1Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
2TOB07TTPT112Smokeless01TOB77777.Condition 1112PRODMSTMOISTCTTProduct Moisture Condition 1 (X°C/ Z% RH)%%TOBACCOContent51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-20232Week 01
3TOB07TTPT113Smokeless01TOB77777.Condition 1113MOISTCTTPRODMSTProduct Moisture Condition 1 (X°C/ Z% RH)%%TOBACCO3Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
4TOB07TTPT114Smokeless01TOB77777.Condition 1114PRODMSTMOISTCTTProduct Moisture Condition 1 (X°C/ Z% RH)%%TOBACCOContent51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-20231Week 842
5TOB07TTPT115Smokeless01TOB77777.Condition 1115MOISTCTTPRODMSTProduct Moisture Condition 1 (X°C/ Z% RH)%%TOBACCO2Week 8Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 824
6TOB07TTPT116Smokeless01TOB77777.Condition 1116PRODMSTMOISTCTTProduct Moisture Condition 1 (X°C/ Z% RH)%%TOBACCOContent51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-20233Week 842
7TOB07TTPT117Smokeless01TOB77777.Condition 1117PRODMSTMOISTCTTProduct Moisture Condition 1 (X°C/ Z% RH)%%TOBACCO1Week 48Content52.05%0.152.0552.05%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 2439
8TOB07TTPT118Smokeless01TOB77777.Condition 1118PRODMSTMOISTCTTProduct Moisture Condition 1 (X°C/ Z% RH)%%TOBACCO2Week 48Content52.68%0.152.6852.68%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 2439
9TOB07TTPT119Smokeless01TOB77777.Condition 1119PRODMSTMOISTCTTProduct Moisture Condition 1 (X°C/ Z% RH)%%TOBACCO3Week 48910TOB07TT120TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCOContent52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243
10TOB07PTSmokeless01Condition 2120MOISTCTTMoisture Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-20231Week 01
11TOB07PTSmokeless01Condition 2TT121MOISTCTTMoisture Content51.96%0TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO251.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
12TOB07TTPTSmokeless01Condition 2122MOISTCTTMoisture Content51.98%0TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO51.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-20233Week 01
13TOB07TT123PTSmokeless01Condition 2123MOISTCTTMoisture Content51.80%0TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO51.8051.80%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-20231Week 842
14TOB07PTSmokeless01Condition 2TT124MOISTCTTMoisture Content51.77%0TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO2Week 851.7751.77%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 824
15TOB07TTPTSmokeless01Condition 2125MOISTCTTMoisture Content51.84%0TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO51.8451.84%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-20233Week 842
16TOB07TTPTSmokeless01Condition 2126MOISTCTTMoisture Content52.18%0TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO1Week 48917TOB07TT127TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO2Week 48918TOB07TT128TOB77777.1PRODMSTProduct MoistureCondition 2 (A °C/ B %RH)%%TOBACCO3Week 4852.1852.18%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
17TOB07PTSmokeless01Condition 2127MOISTCTTMoisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
18TOB07PTSmokeless01Condition 2128MOISTCTTMoisture Content51.87%0.151.8751.87%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243

Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset. The variable STOCONID/Storage Condition ID represents the storage condition and links to the PT datasets by matching values of STOCONID there. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU. The ES dataset shows both sets of storage conditions used across both of the PT dataset examples.

Dataset wrap
Namees
Dataset2
RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11HUMIDHumidity37%
2

TOB07

ESCondition 12TEMPTemperature24C
3

TOB07

ESCondition 21HUMIDHumidity85%
4

TOB07

ESCondition 22TEMPTemperature27C