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
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title | ts.xpt Trial Summary Parameters (study level) |
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title | ts.xpt trial summary (study level parms) |
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| 1 |
| TS | 1 |
| SSTYP | Study Type | REPEAT DOSE TOXICITY |
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2 |
| TS | 1 |
| SPECIES | Species | RAT |
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3 |
| TS | 1 |
| STRAIN | Strain/Substrain | FISCHER 344 |
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4 |
| TS | 1 |
| SPLRNAM | Test Subject Supplier | HARLAN |
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5 |
| TS | 1 |
| SDESIGN | Study Design | CROSSOVER |
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6 |
| TS | 1 |
| ROUTE | Route of Administration | ORAL |
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7 |
| TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
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8 |
| TS | 1 |
| EXPSTDTC | Experimental Start Date | 2008-01-01 |
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9 |
| TS | 1 |
| EXPENDTC | Experimental End Date | 2008-03-07 |
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10 |
| TS | 1 |
| TRMSAC | Time to Terminal Sacrifice | P42D |
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11 |
| TS | 1 |
| STSTDTC | Study Start Date | 2007-12-30 |
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12 |
| TS | 1 |
| DOSDUR | Dosing Duration | P42D |
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13 |
| TS | 1 |
| STITLE | Study Title | Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods |
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14 |
| TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | SEND IMPLEMENTATION GUIDE VERSION 3.2 |
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15 |
| TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-03-26 |
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16 |
| TS | 1 |
| STCAT | Study Category | TOX |
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17 |
| TS | 1 |
| SSPONSOR | Sponsor Organization | Example Sponsor Inc. |
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18 |
| TS | 1 |
| SPREFID | Sponsor's Study Reference ID |
| NOT APPLICABLE |
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19 |
| TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name |
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20 |
| TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
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21 |
| TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
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22 |
| TS | 1 |
| AGETXT | Age Text | 6-8 |
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23 |
| TS | 1 |
| AGEU | Age Unit | WEEKS |
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24 |
| TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
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25 |
| TS | 1 |
| TRT | Investigational Therapy or Treatment | Drug A |
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26 |
| TS | 1 | 2 | TRTV | Treatment Vehicle | Saline |
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| TS | 1 | 2 | TRTVDESC | Treatment Vehicle Structured Description | 100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W} |
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28 |
| TS | 1 |
| GLPFL | GLP Flag | Y |
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29 |
| TS | 1 |
| TRTCAS | Primary Treatment CAS Registry Number |
| TEMPORARILY UNAVAILABLE |
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title | Full SEND ts.xpt FOR REFERENCE |
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| expand | 1 |
| TS | 1 |
| SSTYP | Study Type | REPEAT DOSE TOXICITY |
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2 |
| TS | 1 |
| SPECIES | Species | RAT |
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3 |
| TS | 1 |
| STRAIN | Strain/Substrain | FISCHER 344 |
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4 |
| TS | 1 |
| SPLRNAM | Test Subject Supplier | HARLAN |
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5 |
| TS | 1 |
| SDESIGN | Study Design | CROSSOVER |
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6 |
| TS | 1 |
| ROUTE | Route of Administration | ORAL |
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7 |
| TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
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8 |
| TS | 1 |
| EXPSTDTC | Experimental Start Date | 2008-01-01 |
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9 |
| TS | 1 |
| EXPENDTC | Experimental End Date | 2008-03-07 |
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10 |
| TS | 1 |
| TRMSAC | Time to Terminal Sacrifice | P42D |
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11 |
| TS | 1 |
| STSTDTC | Study Start Date | 2007-12-30 |
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12 |
| TS | 1 |
| DOSDUR | Dosing Duration | P42D |
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13 |
| TS | 1 |
| STITLE | Study Title | Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods |
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14 |
| TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | SEND IMPLEMENTATION GUIDE VERSION 3.2 |
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15 |
| TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-03-26 |
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16 |
| TS | 1 |
| STCAT | Study Category | TOX |
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17 |
| TS | 1 |
| SSPONSOR | Sponsor Organization | Example Sponsor Inc. |
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18 |
| TS | 1 |
| SPREFID | Sponsor's Study Reference ID |
| NOT APPLICABLE |
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19 |
| TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name |
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20 |
| TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
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21 |
| TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
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22 |
| TS | 1 |
| AGETXT | Age Text | 6-8 |
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23 |
| TS | 1 |
| AGEU | Age Unit | WEEKS |
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24 |
| TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
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25 |
| TS | 1 |
| TRT | Investigational Therapy or Treatment | Drug A |
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26 |
| TS | 1 | 2 | TRTV | Treatment Vehicle | Saline |
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27 |
| TS | 1 | 2 | TRTVDESC | Treatment Vehicle Structured Description | 100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W} |
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28 |
| TS | 1 |
| GLPFL | GLP Flag | Y |
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29 |
| TS | 1 |
| TRTCAS | Primary Treatment CAS Registry Number |
| TEMPORARILY UNAVAILABLE |
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Row | STUDYID | ASSAYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT |
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| 1 |
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| TA | ARM01-Prod1 | Cigarette Smoke Condensate, 10 ug/mL | 1 | TREATMT | Treatment | 9 |
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| 9 | SLS-110 | 1 |
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