This is an example showing the report table, trial design, and results from the in vitro bacterial reverse mutation test of an example study, Study #8325064. This bacterial reverse mutation test uses four different amino acid-requiring strains of Salmonella typhimurium (S. typhimurium) and one strain of Escherichia coli (E. coli) to detect point mutations, which involve substitution, addition or deletion of one or a few DNA base pairs. TOBA-129 - Getting issue details... STATUS
In this example, the Trial Summary dataset, ts.xpt, includes many informational fields that may provide context at the study level, for Study 8325064. Also, TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1) and records related to the Test Site (TSGRPID = 2). The Study Director is associated with the Test Facility and the Principal Investigator is associated with the Test Site. Finally, the Primary Treatment CAS Registry Number is not known and this is recorded as an empty TSVAL and UNKNOWN in the corresponding TSVALNF.
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Rows 1-22: | Show trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the data for the vehicle control (i.e., Strain of TA98, vehicle control with concentration value of 0). SetA is associated with the first row, labeled "SetA", in the report table for example study 8325064. |
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Rows 23-44: | Show trial set parameters and trial set values that comprise the test conditions for the set SetR. SetR is the data for the vehicle control (i.e., Strain of TA100, positive control with a concentration value of 2). SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064. |
Rows 13, 35: | Show a value for SPTOBID=CIG01a. SPTOBID is Sponsor-Defined Tobacco Product ID that is used to uniquely identify the tobacco product. The value of SPTOBID, in this case CIG01a, matches the value for SPTOBID in all the TOPARMCD-TOVAL pairs in the Tobacco Product Identifiers and Descriptors (TO) dataset example in Section 3.1.2 Product Design Parameters and Conformance Testing Example 1. The TOPARMCD-TOVAL pairs identify this unique product, CIG01a. The TO domain is described in the Section 2.8.8.1 Tobacco Product Identifiers and Descriptors (TO). |
Rows 21, 43: | Show a value for SPDEVID. SPDEVID is the Sponsor defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset. The value of SPDEVID, in this case PUFFMASTER3K, matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. This is shown in the di.xpt in SDTM Example.Product HPHC ENDS Testing. The DI domain is described in the Section 2.8.9.7 Device Identifiers (DI). |
Rows 22, 44: | Show a value for DUREFID. DUREFID serves as a link to the Device-In Use Properties (DU) domain, where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine, as in the du.xpt in SDTM Example.Product HPHC ENDS Testing. The DU domain is described in the Section 2.8.9.8 Device-In-Use (DU). |
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Aug 23: LAK add F & G to TX and add G data to GT.
Row | STUDYID | GNTXAID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 1 | SPECIES | Species | SALMONELLA TYPHIMURIUM |
2 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 2 | STRAIN | Strain/Substrain | TA98 |
3 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 3 | METACT | Metabolic Activation | NOT APPLICABLE |
4 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 4 | METACTFL | Y/N presence of metabolic activation | N |
5 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 5 | TRTDMIN | Treatment Duration Minimum | 71.5 |
6 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 6 | TRTDTRG | Treatment Duration Target | 72 |
7 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 7 | TRTDMAX | Treatment Duration Maximum | 72.5 |
8 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 8 | TRTDU | Treatment Duration Unit | HOURS |
9 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 9 | INCBTMP | Incubation Temperature | 37 |
10 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 10 | INCBTMPU | Incubation Temperature Unit | C |
11 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 11 | HUMID | Atmospheric Relative Humidity Percent | 50 |
12 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 12 | ATMCO2 | Atmospheric CO2 Percent | 5 |
13 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 13 | SPTOBID | Sponsor defined tobacco identifier | CIG01a |
14 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 14 | EXPTYP | Exposure Type | Submerged |
15 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 15 | SAMTYP | Sample Type | Total Particulate Matter in PBS |
16 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 16 | INTRVN | Name of the intervention article | TA1 |
17 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 17 | ITVTYPE | Type of intervention article | Vehicle Control |
18 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 18 | ITVCONC | Concentration of intervention article | 0 |
19 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 19 | ITVCONCU | Concentration Unit | ug/plate |
20 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 20 | TRTV | Treatment Vehicle | DMSO |
21 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 21 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3K |
22 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 22 | DUREFID | Smoke Regimen | NON-INTENSE REGIMEN |
23 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 23 | SPECIES | Species | SALMONELLA TYPHIMURIUM |
24 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 24 | STRAIN | Strain/Substrain | TA98 |
25 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 25 | METACT | Metabolic Activation | NOT APPLICABLE |
26 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 26 | METACTFL | Y/N presence of metabolic activation | N |
27 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 27 | TRTDMIN | Treatment Duration Minimum | 71.5 |
28 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 28 | TRTDTRG | Treatment Duration Target | 72 |
29 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 29 | TRTDMAX | Treatment Duration Maximum | 72.5 |
30 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 30 | TRTDU | Treatment Duration Unit | HOURS |
31 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 31 | INCBTMP | Incubation Temperature | 37 |
32 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 32 | INCBTMPU | Incubation Temperature Unit | C |
33 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 33 | HUMID | Atmospheric Relative Humidity Percent | 50 |
34 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 34 | ATMCO2 | Atmospheric CO2 Percent | 5 |
35 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 35 | SPTOBID | Sponsor defined tobacco identifier | CIG01a |
36 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 36 | EXPTYP | Exposure Type | Submerged |
37 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 37 | SAMTYP | Sample Type | Total Particulate Matter in PBS |
38 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 38 | INTRVN | Name of the intervention article | TA1 |
39 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 39 | ITVTYPE | Type of intervention article | Vehicle Control |
40 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 40 | ITVCONC | Concentration of intervention article | 500 |
41 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 41 | ITVCONCU | Concentration Unit | ug/plate |
42 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 42 | TRTV | Treatment Vehicle | DMSO |
43 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 43 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3K |
44 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 44 | DUREFID | Smoke Regimen | NON-INTENSE REGIMEN |
45 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 45 | SPECIES | Species | SALMONELLA TYPHIMURIUM |
46 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 46 | STRAIN | Strain/Substrain | TA98 |
47 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 47 | METACT | Metabolic Activation | NOT APPLICABLE |
48 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 48 | METACTFL | Y/N presence of metabolic activation | N |
49 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 49 | TRTDMIN | Treatment Duration Minimum | 71.5 |
50 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 50 | TRTDTRG | Treatment Duration Target | 72 |
51 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 51 | TRTDMAX | Treatment Duration Maximum | 72.5 |
52 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 52 | TRTDU | Treatment Duration Unit | HOURS |
53 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 53 | INCBTMP | Incubation Temperature | 37 |
54 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 54 | INCBTMPU | Incubation Temperature Unit | C |
55 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | HUMID | Atmospheric Relative Humidity Percent | 50 | |
56 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | ATMCO2 | Atmospheric CO2 Percent | 5 | |
57 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | |
58 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | EXPTYP | Exposure Type | Submerged | |
59 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | SAMTYP | Sample Type | Total Particulate Matter in PBS | |
60 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | INTRVN | Name of the intervention article | TA1 | |
61 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | ITVTYPE | Type of intervention article | Vehicle Control | |
62 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | ITVCONC | Concentration of intervention article | 1600 | |
63 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | ITVCONCU | Concentration Unit | ug/plate | |
64 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | TRTV | Treatment Vehicle | DMSO | |
65 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3K | |
66 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | DUREFID | Smoke Regimen | NON-INTENSE REGIMEN | |
67 | 8325064 | Ames | TX | SetR | R-TA100-C2 | SPECIES | Species | Salmonella typhimurium | |
68 | 8325064 | Ames | TX | SetR | R-TA100-C2 | STRAIN | Strain/Substrain | TA100 | |
69 | 8325064 | Ames | TX | SetR | R-TA100-C2 | METACT | Metabolic Activation | NOT APPLICABLE | |
70 | 8325064 | Ames | TX | SetR | R-TA100-C2 | METACTFL | Y/N presence of metabolic activation | N | |
71 | 8325064 | Ames | TX | SetR | R-TA100-C2 | TRTDMIN | Treatment Duration Minimum | 71.5 | |
72 | 8325064 | Ames | TX | SetR | R-TA100-C2 | TRTDTRG | Treatment Duration Target | 72 | |
73 | 8325064 | Ames | TX | SetR | R-TA100-C2 | TRTDMAX | Treatment Duration Maximum | 72.5 | |
74 | 8325064 | Ames | TX | SetR | R-TA100-C2 | TRTDU | Treatment Duration Unit | HOURS | |
75 | 8325064 | Ames | TX | SetR | R-TA100-C2 | INCBTMP | Incubation Temperature | 37 | |
76 | 8325064 | Ames | TX | SetR | R-TA100-C2 | INCBTMPU | Incubation Temperature Unit | C | |
77 | 8325064 | Ames | TX | SetR | R-TA100-C2 | HUMID | Atmospheric Relative Humidity Percent | 50 | |
78 | 8325064 | Ames | TX | SetR | R-TA100-C2 | ATMCO2 | Atmospheric CO2 Percent | 5 | |
79 | 8325064 | Ames | TX | SetR | R-TA100-C2 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | |
80 | 8325064 | Ames | TX | SetR | R-TA100-C2 | EXPTYP | Exposure Type | Submerged | |
81 | 8325064 | Ames | TX | SetR | R-TA100-C2 | SAMTYP | Sample Type | Total Particulate Matter in PBS | |
82 | 8325064 | Ames | TX | SetR | R-TA100-C2 | INTRVN | name of the intervention article | TA1 | |
83 | 8325064 | Ames | TX | SetR | R-TA100-C2 | ITVTYPE | type of intervention article | Positive Control | |
84 | 8325064 | Ames | TX | SetR | R-TA100-C2 | ITVCONC | Concentration of intervention article | 2 | |
85 | 8325064 | Ames | TX | SetR | R-TA100-C2 | ITVCONCU | Concentration Unit | ug/plate | |
86 | 8325064 | Ames | TX | SetR | R-TA100-C2 | TRTV | Treatment Vehicle | DMSO | |
87 | 8325064 | Ames | TX | SetR | R-TA100-C2 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3K | |
88 | 8325064 | Ames | TX | SetR | R-TA100-C2 | DUREFID | Smoke Regimen | NON-INTENSE REGIMEN |
This picture does not depict the more complicated procedures, trial sets, or observational units for our example study, 8325064. For study 8325064, the applicant chose to define the REFIDs at the trial set level with a single character (e.g., A, F, G, R) and chose to define REFIDs at the observational level based on the location of each tube in one of multiple exposure/incubation plates (e.g, 6_1 for plate 6, position 1).
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