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Dataset wrap

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-279

Rowcaps

Rows 1-12:	Show the test conditions for the set with a short name or SETCD value of NRU. The applicant chose this value to represent test conditions for the entire assay.
Rows 13-20:	Show the test conditions for the set with a short name or SETCD value of CSC-50b. The applicant chose this value to represent plate number 1, well row A, well column 3, with a concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123. The value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells.
Rows 21-28:	Show the test conditions for the set with a short name or SETCD value of CSC-50. The applicant chose this value to represent plate number 1, well rows B-G, well column 3 and plate number 2, well rows A-H, well column 3. These all have the concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123.
Rows 29-36:	Show the test conditions for the set with a short name or SETCD value of SLS-110. The applicant chose this value to represent plate number 1, well rows B-G, well column 10, and plate number 2, well rows A-H, well column 10. These all have the concentration of 110µg/mLof sodium laurel sulfate as shown in the report table for study 123.

Dataset2

ORIGINAL

Row

STUDYID

DOMAIN

SETCD

SET

TXSEQ

TXPARMCD

TXPARM

TXVAL

1

123

TX

NRU

NRU_ASSAY

1

IVTDMIN

In vitro Treatment Duration Minimum

47.5

2

123

TX

NRU

NRU_ASSAY

2

IVTDTRG

In vitro Treatment Duration Target

48

3

123

TX

NRU

NRU_ASSAY

3

IVTDMAX

In vitro Treatment Duration Maximum

48.5

4

123

TX

NRU

NRU_ASSAY

4

IVTDU

In vitro Treatment Duration Unit

HOURS

5

123

TX

NRU

NRU_ASSAY

5

INCBTMP

Incubation Temperature

37

6

123

TX

NRU

NRU_ASSAY

6

INCBTMPU

Incubation Temperature Unit

C

7

123

TX

NRU

NRU_ASSAY

7

SWAVENM

Spectrophotometer Wavelength

540

8

123

TX

NRU

NRU_ASSAY

8

ATMRHP

Atmospheric Relative Humidity Percent

90

9

123

TX

NRU

NRU_ASSAY

9

ATMCO2P

Atmospheric CO2 Percent

5

10

123

TX

NRU

NRU_ASSAY

10

SPDEVID

applicant defined device identifier

PUFFMASTER3k

11

123

TX

NRU

NRU_ASSAY

11

SMKRGM

Smoking Regimen

MEDIUM INTENSITY REGIMEN

12

123

TX

NRU

NRU_ASSAY

12

SPTOBID

Applicant-defined tobacco identifier

CIG01a

13

123

TX

CSC-50b

CSC-50-blank

13

PSETCD

Parent Set Code

NRU

14

123

TX

CSC-50b

CSC-50-blank

14

EXPTYP

Exposure Type

Air Liquid Interface

15

123

TX

CSC-50b

CSC-50-blank

15

SAMTYP

Sample Type

Whole Smoke Conditioned Media

16

123

TX

CSC-50b

CSC-50-blank

16

ITVNAM

Name of the Intervention Article

Tobacco ProdA

17

123

TX

CSC-50b

CSC-50-blank

17

ITVTYPE

Intervention Article Type

PRODUCT

18

123

TX

CSC-50b

CSC-50-blank

18

ITVCONC

Intervention Article Concentration

50

19

123

TX

CSC-50b

CSC-50-blank

19

ITVCONCU

Intervention Article Concentration Unit

ug/ml

20

123

TX

CSC-50b

CSC-50-blank

20

CELLLN

Cell Line

NOT APPLICABLE

21

123

TX

CSC-50

21

PSETCD

Parent Set Code

NRU

22

123

TX

CSC-50

22

EXPTYP

Exposure Type

Air Liquid Interface

23

123

TX

CSC-50

23

SAMTYP

Sample Type

Whole Smoke Conditioned Media

24

123

TX

CSC-50

24

ITVNAM

Intervention Article Name

Tobacco ProdA

25

123

TX

CSC-50

25

ITVTYPE

Intervention Article Type

PRODUCT

26

123

TX

CSC-50

26

ITVCONC

Intervention Article Concentration

50

27

123

TX

CSC-50

27

ITVCONCU

Intervention Article Concentration Unit

ug/ml

28

123

TX

CSC-50

28

CELLLN

Cell Line

NHK

29

123

TX

SLS-110

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-599

29

PSETCD

Parent Set Code

NRU

30

123

TX

SLS-110

30

EXPTYP

Exposure Type

Air Liquid Interface

31

123

TX

SLS-110

31

SAMTYP

Sample Type

Liquid

32

123

TX

SLS-110

32

ITVNAM

Intervention Article Name

Sodium Laurel Sulfate

33

123

TX

SLS-110

33

ITVTYPE

Intervention Article Type

POSITIVE CONTROL

34

123

TX

SLS-110

34

ITVCONC

Intervention Article Concentration

110

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-600

35

123

TX

SLS-110

35

ITVCONCU

Intervention Article Concentration Unit

ug/ml

36

123

TX

SLS-110

36

CELLLN

Cell Line

NHK

FLATTENED

ROW

STUDYID

DOMAIN

SETCD

SET

TXSEQ

TXPARMCD

TXPARM

TXVAL

1

123

TX

NRU

NRU_ASSAY

1

IVTDMIN

In vitro Treatment Duration Minimum

47.5

2

123

TX

NRU

NRU_ASSAY

2

IVTDTRG

In vitro Treatment Duration Target

48

3

123

TX

NRU

NRU_ASSAY

3

IVTDMAX

In vitro Treatment Duration Maximum

48.5

4

123

TX

NRU

NRU_ASSAY

4

IVTDU

In vitro Treatment Duration Unit

HOURS

5

123

TX

NRU

NRU_ASSAY

5

INCBTMP

Incubation Temperature

37

6

123

TX

NRU

NRU_ASSAY

6

INCBTMPU

Incubation Temperature Unit

C

7

123

TX

NRU

NRU_ASSAY

7

SWAVENM

Spectrophotometer Wavelength

540

8

123

TX

NRU

NRU_ASSAY

8

ATMRHP

Atmospheric Relative Humidity Percent

90

9

123

TX

NRU

NRU_ASSAY

9

ATMCO2P

Atmospheric CO2 Percent

5

10

123

TX

NRU

NRU_ASSAY

10

SPDEVID

applicant defined device identifier

PUFFMASTER3k

11

123

TX

NRU

NRU_ASSAY

11

SMKRGM

Smoking Regimen

MEDIUM INTENSITY REGIMEN

12

123

TX

NRU

NRU_ASSAY

12

SPTOBID

Applicant-defined tobacco identifier

CIG01a

13

123

TX

CSC-50b

CSC-50-blank

13

IVTDMIN

In vitro Treatment Duration Minimum

47.5

14

123

TX

CSC-50b

CSC-50-blank

14

IVTDTRG

In vitro Treatment Duration Target

48

15

123

TX

CSC-50b

CSC-50-blank

15

IVTDMAX

In vitro Treatment Duration Maximum

48.5

16

123

TX

CSC-50b

CSC-50-blank

16

IVTDU

In vitro Treatment Duration Unit

HOURS

17

123

TX

CSC-50b

CSC-50-blank

17

INCBTMP

Incubation Temperature

37

18

123

TX

CSC-50b

CSC-50-blank

18

INCBTMPU

Incubation Temperature Unit

C

19

123

TX

CSC-50b

CSC-50-blank

19

SWAVENM

Spectrophotometer Wavelength

540

20

123

TX

CSC-50b

CSC-50-blank

20

ATMRHP

Atmospheric Relative Humidity Percent

90

21

123

TX

CSC-50b

CSC-50-blank

21

ATMCO2P

Atmospheric CO2 Percent

5

22

123

TX

CSC-50b

CSC-50-blank

22

SPDEVID

applicant defined device identifier

PUFFMASTER3k

23

123

TX

CSC-50b

CSC-50-blank

23

SMKRGM

Smoking Regimen

MEDIUM INTENSITY REGIMEN

24

123

TX

CSC-50b

CSC-50-blank

24

SPTOBID

Applicant-defined tobacco identifier

CIG01a

25

123

TX

CSC-50b

CSC-50-blank

25

EXPTYP

Exposure Type

Air Liquid Interface

26

123

TX

CSC-50b

CSC-50-blank

26

SAMTYP

Sample Type

Whole Smoke Conditioned Media

27

123

TX

CSC-50b

CSC-50-blank

27

ITVNAM

Name of the Intervention Article

Tobacco ProdA

28

123

TX

CSC-50b

CSC-50-blank

28

ITVTYPE

Intervention Article Type

PRODUCT

29

123

TX

CSC-50b

CSC-50-blank

29

ITVCONC

Intervention Article Concentration

50

30

123

TX

CSC-50b

CSC-50-blank

30

ITVCONCU

Intervention Article Concentration Unit

ug/ml

31

123

TX

CSC-50b

CSC-50-blank

31

CELLLN

Cell Line

NOT APPLICABLE

32

123

TX

CSC-50

32

IVTDMIN

In vitro Treatment Duration Minimum

47.5

33

123

TX

CSC-50

33

IVTDTRG

In vitro Treatment Duration Target

48

34

123

TX

CSC-50

34

IVTDMAX

In vitro Treatment Duration Maximum

48.5

35

123

TX

CSC-50

35

IVTDU

In vitro Treatment Duration Unit

HOURS

36

123

TX

CSC-50

36

INCBTMP

Incubation Temperature

37

123

TX

CSC-50

37

INCBTMPU

Incubation Temperature Unit

C

38

123

TX

CSC-50

38

SWAVENM

Spectrophotometer Wavelength

540

39

123

TX

CSC-50

39

ATMRHP

Atmospheric Relative Humidity Percent

90

40

123

TX

CSC-50

40

ATMCO2P

Atmospheric CO2 Percent

5

41

123

TX

CSC-50

41

SPDEVID

applicant defined device identifier

PUFFMASTER3k

42

123

TX

CSC-50

42

SMKRGM

Smoking Regimen

MEDIUM INTENSITY REGIMEN

43

123

TX

CSC-50

43

EXPTYP

Exposure Type

Air Liquid Interface

44

123

TX

CSC-50

44

SAMTYP

Sample Type

Whole Smoke Conditioned Media

45

123

TX

CSC-50

45

ITVNAM

Intervention Article Name

Tobacco ProdA

46

123

TX

CSC-50

46

ITVTYPE

Intervention Article Type

PRODUCT

47

123

TX

CSC-50

47

ITVCONC

Intervention Article Concentration

50

48

123

TX

CSC-50

48

ITVCONCU

Intervention Article Concentration Unit

ug/ml

49

123

TX

CSC-50

49

CELLLN

Cell Line

NHK

50

123

TX

SLS-110

50

IVTDMIN

In vitro Treatment Duration Minimum

47.5

51

123

TX

SLS-110

51

IVTDTRG

In vitro Treatment Duration Target

48

52

123

TX

SLS-110

52

IVTDMAX

In vitro Treatment Duration Maximum

48.5

53

123

TX

SLS-110

53

IVTDU

In vitro Treatment Duration Unit

HOURS

54

123

TX

SLS-110

54

INCBTMP

Incubation Temperature

37

55

123

TX

SLS-110

55

INCBTMPU

Incubation Temperature Unit

C

56

123

TX

SLS-110

56

SWAVENM

Spectrophotometer Wavelength

540

57

123

TX

SLS-110

57

ATMRHP

Atmospheric Relative Humidity Percent

90

58

123

TX

SLS-110

58

ATMCO2P

Atmospheric CO2 Percent

5

59

123

TX

SLS-110

59

SPDEVID

applicant defined device identifier

PUFFMASTER3k

60

123

TX

SLS-110

60

SMKRGM

Smoking Regimen

MEDIUM INTENSITY REGIMEN

61

123

TX

SLS-110

61

SPTOBID

Applicant-defined tobacco identifier

CIG01a

62

123

TX

SLS-110

62

EXPTYP

Exposure Type

Air Liquid Interface

63

123

TX

SLS-110

63

SAMTYP

Sample Type

Liquid

64

123

TX

SLS-110

64

ITVNAM

Intervention Article Name

Sodium Laurel Sulfate

65

123

TX

SLS-110

65

ITVTYPE

Intervention Article Type

POSITIVE CONTROL

66

123

TX

SLS-110

66

ITVCONC

Intervention Article Concentration

110

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-600

67

123

TX

SLS-110

67

ITVCONCU

Intervention Article Concentration Unit

ug/ml

68

123

TX

SLS-110

68

CELLLN

Cell Line

NHK

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-461

Dataset wrap

Name	relref

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-280

Rowcaps

The applicant chose to define the REFID values to indicate the Plate, the Column, and the Row of the wells of the 96-well plate in use, such that the well on plate 2, column 10, row G would assigned a REFID of 2-10-G.

Row 1:	Shows the REFID of 123NRU that indicates the entire assay.
Rows 2, 5, 8, 9:-4:	Show the REFIDs at the second level, all within the parent assay of 123NRU (REFID values of 1-3b, 1-3, 1-10, 2-10) which have LVLDESC of OBSERVATIONAL UNITSUMMARY. If this study had recorded summary statistics for an entire trial set (e.g., across both plates for the same dose level), there would be an additional REFID for the trial set (with a LVLDESC of TRIAL SET).
Rows 35-4, 6-7, 10-11:	Show REFID values that the applicant chose, in this case, to represent the plate number (1 or 2), column (1 - 12), and row (A-G) of the 96-well plates.	Show the	Rows 3-4:	Show the REFIDs 1-3-A and 1-3-H that indicate two experimental units that are also observational units within the parent trial set of 1-3bSETCD of CSC-50b that have the parent REFID of 123NRU.
Rows 67-78:	Show the REFIDs 1-3-B and 1-3-C that indicate two experimental units that are also observational units within the parent trial set SETCD of CSC-50 that have the parent REFID of 1-3.
Row 109:	Shows the REFID of 1-10-G that indicates the experimental unit that is also an observational unit within the parent trial set SETCD of SLS-110 that has the parent REFID of 1-10.
Row 1110:	Shows the REFID of 2-10-G that indicates the experimental unit that is also an observational unit within the parent trial set SETCD of SLS-110 that has the parent REFID of 2-10.

OBSERVATIONAL UNIT

Dataset2

tableid	relref

OLD Row

STUDYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

123

NRU

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-475

123NRU

1

ASSAY

2

5

123

CSC-50

1-3

123NRU

2

OBSERVATIONAL SUMMARY

3

8

123

SLS-110

1-10

123NRU

2

OBSERVATIONAL SUMMARY

4

9

123

CSC

SLS-

50b

110

1

2-

3b

10

123NRU

2

OBSERVATIONAL

UNIT

SUMMARY
5	3		123	CSC-50b	1-3-A

1-3b

123NRU

3

2	EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
6	4		123	CSC-50b	1-3-H

1-3b

123NRU

3

2	EXPERIMENTAL UNIT/OBSERVATIONAL UNIT

5

123

CSC-50

1-3

123NRU

2

7	6		123	CSC-50	1-3-B	1-3	3	EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
8	7		123	CSC-50	1-3-C	1-3	3	EXPERIMENTAL UNIT/

OBSERVATIONAL UNIT

8

123

SLS-110

1-10

123NRU

2

OBSERVATIONAL UNIT

9

123

SLS-1102-10

10

123NRU2OBSERVATIONAL UNIT

123	SLS-110	1-10-G	1-10	3	EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
10	11		123	SLS-110	2-10-G	2-10	3	EXPERIMENTAL UNIT/OBSERVATIONAL UNIT

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