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 (study level parms) |
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| SSTYP | Study Type | REPEAT DOSE TOXICITY |
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| SPECIES | Species | RAT |
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| STRAIN | Strain/Substrain | FISCHER 344 |
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| SPLRNAM | Test Subject Supplier | HARLAN |
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| SDESIGN | Study Design | CROSSOVER |
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| ROUTE | Route of Administration | ORAL |
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| GLPTYP | Good Laboratory Practice Type | FDA |
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| EXPSTDTC | Experimental Start Date | 2008-01-01 |
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| EXPENDTC | Experimental End Date | 2008-03-07 |
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| TRMSAC | Time to Terminal Sacrifice | P42D |
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| STSTDTC | Study Start Date | 2007-12-30 |
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| DOSDUR | Dosing Duration | P42D |
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| STITLE | Study Title | Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods |
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| SNDIGVER | SEND Implementation Guide Version | SEND IMPLEMENTATION GUIDE VERSION 3.2 |
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| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-03-26 |
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| STCAT | Study Category | TOX |
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| SSPONSOR | Sponsor Organization | Example Sponsor Inc. |
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| SPREFID | Sponsor's Study Reference ID |
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| TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name |
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| TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
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| TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
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| AGETXT | Age Text | 6-8 |
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| AGEU | Age Unit | WEEKS |
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| TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
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| TRT | Investigational Therapy or Treatment | Drug A |
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| 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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| GLPFL | GLP Flag | Y |
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| TRTCAS | Primary Treatment CAS Registry Number |
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| Row | STUDYID | ASSAYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT |
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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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| title | te.xpt (trial elements) |
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| Row | STUDYID | ASSAYID | DOMAIN | ETCD | ELEMENT |
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| TE | TREATMT | Treatment |
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| 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 |
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| TA | ARM01-Prod1 | Cigarette Smoke Condensate, 10 ug/mL | 1 | TREATMT | Treatment | | 2 |
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| TA | ARM02-Prod1 | Cigarette Smoke Condensate, 50 ug/mL | 1 | TREATMT | Treatment | | 3 |
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| TA | ARM03-Prod1 | Cigarette Smoke Condensate, 75 ug/mL | 1 | TREATMT | Treatment | | 4 |
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| 9 | SLS-110 | 1 |
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| ARM10 | SLS-200 | 1 |
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TE.XPT TRIAL ELEMENTS | Row | STUDYID | ASSAYID | DOMAIN | ETCD | ELEMENT |
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| 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 |
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| CS-10 | Cigarette Smoke Condensate, 10 ug/mL |
| METACT | Metabolic Activation | +S9 | | 2 |
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| CS-10 | Cigarette Smoke Condensate, 10 ug/mL |
| METACT | Metabolic Activation | -S9 |
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| TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL |
| ARMCD | Arm Code | CS-10 |
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| TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL |
| SPECIES | Species | Salmonella enterica |
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| TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL |
| STRAIN | Strain/Substrain | Salmonella enterica enterica |
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| TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL |
| PRODUCT | Product | product A |
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| TX | CS-10 | Cigarette Smoke Condensate, 10 ug/mL |
| REGIME | Smoking Regime | Traditional combustible |
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| TX | CS-20 | Cigarette Smoke Condensate, 50 ug/mL |
| ARMCD | Arm Code | CS-20 |
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| TX | CS-20 | Cigarette Smoke Condensate, 50 ug/mL |
| PRODUCT | Product | product A |
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| TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL |
| TRTDOS | Dose Level | 100 |
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| TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL |
| TCNTRL | Control Type | POSITIVE CONTROL |
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| TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL |
| CNTLAG | Control Agent | SODIUM LAURYL SULPHATE |
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| TX | LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL |
| CNTLAGAMT | Control Agent amount (levels) | 110 |
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| LSL-200 | sodium lauryl sulphate (SLS) positive control, 200 ug/mL |
| CNTLAGUNIT | Control Agent Unit | ug/mL |
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| Row | STUDYID | DOMAIN | ENID (Entity ID) | ST vs. LT | Activation (+S9, -S9) |
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| 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 |
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| 1 | MA99999 | EI | 1 |
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| 1-1 | 030001 | A | 1 | 1 | 1 | A |
| CS-10 | 2008-04-01T06:00 | | 2008-04-02T14:00 | 2008-04-02T14:04 | 2008-04-01T06:00 | 2008-04-01T06:00 | 3 |
| | 2 | MA99999 | EI | 2 |
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| 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 |
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