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titletx.xpt (trial sets)
  • Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor applicant designations as specified in the trial design.
  • During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled;  For now, we just include good example values based on our experience
  • Where are the details of the smoke regime defined/submitted today? (e.g., puff profile = Bell shaped puffing volumes; Puff Block = 50%, etc.)
RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVALDefinitions
1123NRUTX1-1-A
(plate-col-row in the 96-well plate)
CSC-10
(through SLS-200)

PLATENUM. (e.g., 1 or 2)
1
2123NRUTX1-1-ACSC-10
WELLNUM (e.g., 1-A through 10-H)
Number representing the location of the well in the 96-well plate1-A 
3123NRUTX1-1-ACSC-10
INTRVNname of the intervention articleCigarette Smoke Condensate
4123NRUTX1-1-ACSC-10
ITVTYPE
(CT e.g, Product, positive control, negative control)
type of intervention articlePRODUCT
5123NRUTX1-1-ACSC-10
ITVCONCintervention concentration10
6123NRUTX1-1-ACSC-10
ITVCONCUintervention unitug/ml
7123NRUTX1-1-ACSC-10
STRAINStrain/SubstrainSalmonella enterica enterica
8123NRUTX1-1-ACSC-10
REGIMESmoking RegimeTraditional combustible 
9123NRUTX1-1-ACSC-10
RUN

Assay run number

1


10

123NRUTX1-1-ACSC-10
PORTPort ID1
11123NRUTX1-1-ACSC-10
SMPLIDSample ID030001
12123NRUTX1-1-ACSC-10
SMKFRCSmoke FractionA
13123NRUTX1-1-ACSC-10
REPNUMReplicate Number1
1123NRUTX1-1-BCSC-10
PLATENUM. (e.g., 1 or 2)
1
2123NRUTX1-1-BCSC-10
WELLNUM (e.g., 1-A through 10-H)
Number representing the location of the well in the 96-well plate1-A 
3123NRUTX1-1-BCSC-10
INTRVNname of the intervention articleCigarette Smoke Condensate
4123NRUTX1-1-BCSC-10
ITVTYPE
(CT e.g, Product, positive control, negative control)
type of intervention articlePRODUCT
5123NRUTX1-1-BCSC-10
ITVCONCintervention concentration10
6123NRUTX1-1-BCSC-10
ITVCONCUintervention unitug/ml
7123NRUTX1-1-BCSC-10
STRAINStrain/SubstrainSalmonella enterica enterica
8123NRUTX1-1-BCSC-10
REGIMESmoking RegimeTraditional combustible 
9123NRUTX1-1-BCSC-10
RUN (Test Result, use to analyze for biases, group of replicates over time frame and lab condition)

Assay run number

1

Identified at result level, 

10

123NRUTX1-1-BCSC-10
PORTPort ID1
11123NRUTX1-1-BCSC-10
SMPLIDSample ID030001
12123NRUTX1-1-BCSC-10
SMKFRCSmoke FractionA
13123NRUTX1-1-BCSC-10
REPNUM (Replicated independent separate samples prepared and run the same vs.  duplicates across wells, running the same replicate across many  wells)Replicate Number1


Trial = Sample preps vs.

Replicates = different plates

Col/Row = testing of an individual sample multiple times























14123NRUTX1-1-BCSC-10
ITVCONCintervention concentration10
15123NRUTX1-1-BCSC-10
ITVCONCUintervention unitug/ml
...


...






123NRUTX1-10-HSLS-10
PLATENUMPlate number1  

123NRUTX1-10-HSLS-10
WELLNUMNumber representing the location of the well in the 96-well plate10-H

123NRUTX1-10-HSLS-10
INTRVNname of the intervention articlesodium laurel sulfate

123NRUTX1-10-HSLS-10
ITVTYPEtype of intervention articlePOSITIVE CONTROL

123NRUTX1-10-HSLS-10
ITVCONCintervention concentration200

123NRUTX1-10-HSLS-10
ITVCONCUintervention unitug/ml
...


...






123NRUTX2-10-HSLS-10
PLATENUMPlate number2

123NRUTX2-10-HSLS-10
WELLNUMNumber representing the location of the well in the 96-well plate10-H

123NRUTX2-10-HSLS-10
INTRVNname of the intervention articlesodium laurel sulfate

123NRUTX2-10-HSLS-10
ITVTYPEtype of intervention articlePOSITIVE CONTROL

123NRUTX2-10-HSLS-10
ITVCONCintervention concentration200

123NRUTX2-10-HSLS-10
ITVCONCUintervention unitug/ml
Expand
titlegt.xpt (similar to LB)

RowSTUDYIDASSAYIDDOMAINTXSETCDGTSEQGTTESTCDGTTESTGTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESU
1123NRUGT1-1-A1RELABSRelative Absorbance Reading100ug/ml100100ug/ml
2123NRUGT1-1-B1RELABSRelative Absorbance Reading107ug/ml100100ug/ml
3123NRUGT1-1-C1RELABSRelative Absorbance Reading98.6ug/ml100100ug/ml
4123NRUGT1-1-D1RELABSRelative Absorbance Reading94.9ug/ml100100ug/ml
5123NRUGT1-1-E1RELABSRelative Absorbance Reading111ug/ml111111ug/ml

123NRUGT1-1-F1RELABSRelative Absorbance Reading96.9ug/ml96.996.9ug/ml

123NRUGT1-1-G1RELABSRelative Absorbance Reading105ug/ml105105ug/ml

123NRUGT1-1-H1RELABSRelative Absorbance Reading95.2ug/ml95.295.2ug/ml
10123NRUGT1-2-A1RELABSRelative Absorbance Reading

83.0

ug/ml83.083.0ug/ml
11123NRUGT1-2-B1RELABSRelative Absorbance Reading77.7

ug/ml

77.777.7ug/ml
...


...







80123NRUGT1-10-H1RELABSRelative Absorbance Reading0.791ug/ml0.7910.791ug/ml
...


...







160123NRUGT2-10-H1RELABSRelative Absorbance Reading0.780ug/ml0.7800.780ug/ml