- Created by Lou Ann Kramer, last modified on Jul 29, 2022
You are viewing an old version of this page. View the current version.
Compare with Current View Page History
« Previous Version 6 Next »
This is an example showing trial design and results data of Study #123 for the determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay
Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
---|---|---|---|---|---|---|---|---|
1 | TS | 1 | SSTYP | Study Type | REPEAT DOSE TOXICITY | |||
2 | TS | 1 | SPECIES | Species | RAT | |||
3 | TS | 1 | STRAIN | Strain/Substrain | FISCHER 344 | |||
4 | TS | 1 | SPLRNAM | Test Subject Supplier | HARLAN | |||
5 | TS | 1 | SDESIGN | Study Design | CROSSOVER | |||
6 | TS | 1 | ROUTE | Route of Administration | ORAL | |||
7 | TS | 1 | GLPTYP | Good Laboratory Practice Type | FDA | |||
8 | TS | 1 | EXPSTDTC | Experimental Start Date | 2008-01-01 | |||
9 | TS | 1 | EXPENDTC | Experimental End Date | 2008-03-07 | |||
10 | TS | 1 | TRMSAC | Time to Terminal Sacrifice | P42D | |||
11 | TS | 1 | STSTDTC | Study Start Date | 2007-12-30 | |||
12 | TS | 1 | DOSDUR | Dosing Duration | P42D | |||
13 | TS | 1 | STITLE | Study Title | Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods | |||
14 | TS | 1 | SNDIGVER | SEND Implementation Guide Version | SEND IMPLEMENTATION GUIDE VERSION 3.2 | |||
15 | TS | 1 | SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-03-26 | |||
16 | TS | 1 | STCAT | Study Category | TOX | |||
17 | TS | 1 | SSPONSOR | Sponsor Organization | Example Sponsor Inc. | |||
18 | TS | 1 | SPREFID | Sponsor's Study Reference ID | NOT APPLICABLE | |||
19 | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name | ||
20 | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 | ||
21 | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA | ||
22 | TS | 1 | AGETXT | Age Text | 6-8 | |||
23 | TS | 1 | AGEU | Age Unit | WEEKS | |||
24 | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith | ||
25 | TS | 1 | TRT | Investigational Therapy or Treatment | Drug A | |||
26 | TS | 1 | 2 | TRTV | Treatment Vehicle | Saline | ||
27 | TS | 1 | 2 | TRTVDESC | Treatment Vehicle Structured Description | 100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W} | ||
28 | TS | 1 | GLPFL | GLP Flag | Y | |||
29 | TS | 1 | TRTCAS | Primary Treatment CAS Registry Number | TEMPORARILY UNAVAILABLE |
Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
---|---|---|---|---|---|---|---|---|
1 | TS | 1 | SSTYP | Study Type | REPEAT DOSE TOXICITY | |||
2 | TS | 1 | SPECIES | Species | RAT | |||
3 | TS | 1 | STRAIN | Strain/Substrain | FISCHER 344 | |||
4 | TS | 1 | SPLRNAM | Test Subject Supplier | HARLAN | |||
5 | TS | 1 | SDESIGN | Study Design | CROSSOVER | |||
6 | TS | 1 | ROUTE | Route of Administration | ORAL | |||
7 | TS | 1 | GLPTYP | Good Laboratory Practice Type | FDA | |||
8 | TS | 1 | EXPSTDTC | Experimental Start Date | 2008-01-01 | |||
9 | TS | 1 | EXPENDTC | Experimental End Date | 2008-03-07 | |||
10 | TS | 1 | TRMSAC | Time to Terminal Sacrifice | P42D | |||
11 | TS | 1 | STSTDTC | Study Start Date | 2007-12-30 | |||
12 | TS | 1 | DOSDUR | Dosing Duration | P42D | |||
13 | TS | 1 | STITLE | Study Title | Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods | |||
14 | TS | 1 | SNDIGVER | SEND Implementation Guide Version | SEND IMPLEMENTATION GUIDE VERSION 3.2 | |||
15 | TS | 1 | SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-03-26 | |||
16 | TS | 1 | STCAT | Study Category | TOX | |||
17 | TS | 1 | SSPONSOR | Sponsor Organization | Example Sponsor Inc. | |||
18 | TS | 1 | SPREFID | Sponsor's Study Reference ID | NOT APPLICABLE | |||
19 | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name | ||
20 | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 | ||
21 | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA | ||
22 | TS | 1 | AGETXT | Age Text | 6-8 | |||
23 | TS | 1 | AGEU | Age Unit | WEEKS | |||
24 | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith | ||
25 | TS | 1 | TRT | Investigational Therapy or Treatment | Drug A | |||
26 | TS | 1 | 2 | TRTV | Treatment Vehicle | Saline | ||
27 | TS | 1 | 2 | TRTVDESC | Treatment Vehicle Structured Description | 100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W} | ||
28 | TS | 1 | GLPFL | GLP Flag | Y | |||
29 | TS | 1 | TRTCAS | Primary Treatment CAS Registry Number | TEMPORARILY UNAVAILABLE |
Row | STUDYID | ASSAYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT |
---|---|---|---|---|---|---|---|---|
1 | TA | ARM01-Prod1 | Cigarette Smoke Condensate, 10 ug/mL | 1 | TREATMT | Treatment | ||
9 | 9 | SLS-110 | 1 |
Row | STUDYID | ASSAYID | DOMAIN | ETCD | ELEMENT |
---|---|---|---|---|---|
TE | TREATMT | Treatment |
Red font (CT is coming!, POSITIVE CONTROL, VEHICLE CONTROL, etc.)
ARMCD. TREATMENT (element). SETCD
ARM01 TREATMT. CS-01. (Cigarette Smoke 10 ug/mL)
ARM01
TA.XPT
TRIAL ARMS
Row | STUDYID | ASSAYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT |
---|---|---|---|---|---|---|---|---|
1 | TA | ARM01-Prod1 | Cigarette Smoke Condensate, 10 ug/mL | 1 | TREATMT | Treatment | ||
2 | TA | ARM02-Prod1 | Cigarette Smoke Condensate, 50 ug/mL | 1 | TREATMT | Treatment | ||
3 | TA | ARM03-Prod1 | Cigarette Smoke Condensate, 75 ug/mL | 1 | TREATMT | Treatment | ||
4 | TA | 4 | 1 | |||||
5 | TA | 5 | 1 | |||||
6 | TA | 6 | 1 | |||||
7 | 7 | 1 | ||||||
8 | 8 | 1 | ||||||
9 | 9 | SLS-110 | 1 | |||||
10 | ARM10 | SLS-200 | 1 |
TE.XPT
TRIAL ELEMENTS
Row | STUDYID | ASSAYID | DOMAIN | ETCD | ELEMENT |
---|---|---|---|---|---|
TE | TREATMT | Treatment |
tx.spt
TRIAL SET
example: Each plate has a separate product
Product, Smoking Regime (e.g. Traditional combustible, ENDS), Smoke Fraction, etc.
https://www.itis.gov/servlet/SingleRpt/SingleRpt?search_topic=TSN&search_value=969610#null
Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
---|---|---|---|---|---|---|---|---|---|
1 | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | METACT | Metabolic Activation | +S9 | ||||
2 | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | METACT | Metabolic Activation | -S9 | ||||
TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | ARMCD | Arm Code | CS-10 | ||||
TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | SPECIES | Species | Salmonella enterica | ||||
TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | STRAIN | Strain/Substrain | Salmonella enterica enterica | ||||
TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | PRODUCT | Product | product A | ||||
TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL | REGIME | Smoking Regime | Traditional combustible | ||||
TX | CS-20 | Cigarette Smoke Condensate, 50 ug/mL | ARMCD | Arm Code | CS-20 | ||||
TX | CS-20 | Cigarette Smoke Condensate, 50 ug/mL | PRODUCT | Product | product A | ||||
... | |||||||||
TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL | TRTDOS | Dose Level | 100 | ||||
TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL | TCNTRL | Control Type | POSITIVE CONTROL | ||||
TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL | CNTLAG | Control Agent | SODIUM LAURYL SULPHATE | ||||
TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL | CNTLAGAMT | Control Agent amount (levels) | 110 | ||||
LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL | CNTLAGUNIT | Control Agent Unit | ug/mL |
Row | STUDYID | DOMAIN | ENID (Entity ID) | ST vs. LT | Activation (+S9, -S9) | RUNID (Run-Port Number) | SMPID (Sample ID) | SMKFID (Smoke Fraction) | REPLCTID (Replicate Number) | PLATEID (Plate ID) | COLID (Column number) | ROWID (Row number) | SETCD (Set Code, TX) | RFSTDTC | RFENDTC | RFXSTDTC | RFXENDTC | RFCSTDTC | RFCENDTC | ARMCD | |||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | MA99999 | EI | 1 | 1-1 | 030001 | A | 1 | 1 | 1 | A | CS-10 | 2008-04-01T06:00 | 2008-04-28T14:00 | 2008-04-02T14:00 | 2008-04-02T14:04 | 2008-04-01T06:00 | 2008-04-01T06:00 | 3 | |||||||
2 | MA99999 | EI | 2 | 1-1 | 030001 | A | 1 | 1 | 1 | B | CS-10 | 2008-04-01T06:00 | 2008-04-21T14:00 | 2008-04-02T20:00 | 2008-04-02T20:04 | 2008-04-01T06:00 | 2008-04-01T06:00 | 3 |
- Entity ID links to EI domain (usubjid)
- TEST: After ST exposure to increasing concentrations of test article in the presence of S9 mix
Row | STUDYID | DOMAIN | ENID (Entity ID) | GTSEQ | GTTESTCD | GTTEST | GTORRES | GTORRESU | GTSTRESC | GTSTRESN | GTSTRESU | GTSPEC??? | GTMETHOD | GTDTC | GTDY | GTNOMDY | GTELTM | GTTPTREF |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | ST487-12 | GT | 1 | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL | |||||||||||
2 | ST487-12 | GT | 2 | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL | |||||||||||
3 | ST487-12 | GT | 3 | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL | |||||||||||
4 | ST487-12 | GT | 4 | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL | |||||||||||
5 | ST487-12 | GT | 5 | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL | |||||||||||
6 | ST487-12 | GT | 6 | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL | |||||||||||
7 | ST487-12 | GT | 7 | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL | |||||||||||
8 | ST487-12 | GT | 8 | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL | |||||||||||
9 | ST487-12 | GT | 9 | MNT | In vitro Micronucleus Assay | ug/mL | ug/mL |
- No labels