Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
---|
1 | XYZ | TS | 1 |
| SSTYP | Study Type | REPEAT DOSE TOXICITY |
| 2 | XYZ | TS | 1 |
| SPECIES | Species | RAT |
| 3 | XYZ | TS | 1 |
| STRAIN | Strain/Substrain | FISCHER 344 |
| 4 | XYZ | TS | 1 |
| SBSTRAIN | Strain/Substrain Details | NON-DIABETIC OBESE RAT |
| 5 | XYZ | TS | 1 |
| SPLRNAM | Test Subject Supplier | Example Supplier |
| 6 | XYZ | TS | 1 |
| SDESIGN | Study Design | PARALLEL |
| 7 | XYZ | TS | 1 |
| ROUTE | Route of Administration | ORAL |
| 8 | XYZ | TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
| 9 | XYZ | TS | 2 |
| GLPTYP | Good Laboratory Practice Type | OECD |
| 10 | XYZ | TS | 1 |
| EXPSTDTC | Experimental Start Date | 2008-01-01 |
| 11 | XYZ | TS | 1 |
| EXPENDTC | Experimental End Date | 2008-02-13 |
| 12 | XYZ | TS | 1 |
| DOSDUR | Dosing Duration | P28D |
| 13 | XYZ | TS | 1 |
| STITLE | Study Title | Example of a 4-week Repeat-Dose Toxicity Study in Rats with a 1-week Recovery |
| 14 | XYZ | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | SEND Implementation Guide Version 3.1.1 |
| 15 | XYZ | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2023-06-30 |
| 16 | XYZ | TS | 1 |
| STCAT | Study Category | TOX |
| 17 | XYZ | TS | 1 | SSPONSORSponsoring Applicant Organization | Example | Sponsor Applicant Inc. |
| 18 | XYZ | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Contract Lab Name |
| 19 | XYZ | TS | 1 | 1 | TSTFLOC | Test Facility Location | 1000 Anywhere Street, Honolulu, HI 11111 |
| 20 | XYZ | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
| 21 | XYZ | TS | 1 | 2 | TSNAM | Test Site Name | Example Subcontract Lab Name |
| 22 | XYZ | TS | 1 | 2 | TSLOC | Test Site Location | 1000 | Nowhere Allen Street Omaha, NE 88888 |
| 23 | XYZ | TS | 1 | 2 | TSCNTRY | Test Site Country | USA |
| 24 | XYZ | TS | 1 |
| STSTDTC | Study Start Date | 2007-12-30 |
| 25 | XYZ | TS | 1 |
| STENDTC | Study End Date | 2008-06-01 |
| 26 |
XYZ | TS | 1 | ASOCSTDY | Associated Study | Associated pharmacokinetic Study | 272830 | XYZ | TS | 1 | STMON | Sponsor's Monitor | Dr. J. Smith | 31 |
| 27 | XYZ | TS | 1 |
| AGEU | Age Unit | WEEKS |
29 | XYZ | TS | 1 | SPREFID | Sponsor's Reference ID | SP/StudyID | XYZ | TS | 1 | 1 | STDIR | Study Director | Dr. H. Someone | 32
| 29 | XYZ | TS | 1 | 2 | PINV | Principal Investigator | G. Person |
33 | XYZ | TS | 136 | XYZ | TS | 1 | ENVTEMP | Environmental Temperature | 70-75 | 37 | XYZ | TS | 1 | ENVTEMPU | Environmental Temperature Units | F | 38 | XYZ | TS | 1 | HUMIDT | Housing Humidity | 10-IDMETH | Method of Identification | MICROCHIP | 34 | XYZ | TS | 1 | IACUC | IACUC Number | 1234A | 35 | XYZ | TS | 1 | WATER | Drinking Water | REVERSE OSMOSIS | 39 | XYZ | TS | 1 | HUMIDTU | Housing Humidity Units | % | 40 | XYZ | TS | 1 | LIGHT | Light Cycle | 12 / 12 | 41 | XYZ | TS | 1 | HOUSEGRP | Housing Group | SINGLE | 42 | XYZ | TS | 1 | BEDDING | Bedding | STRAW | 43 | XYZ | TS | 1 | BEDCHNG | Bedding Change | WEEKLY44 | MTHTRM | Method of Termination | CO247 | XYZ | TS | 1 | INTSAC | Time to Interim Sacrifice | P14D | 48 | XYZ | TS | 1 | TRMSAC | Time to Terminal Sacrifice | P28D | 49 | XYZ | TS | 1 | RECSAC | Recovery Period | P35D | 50 | XYZ | TS | 1 | 45 | XYZ | TS | 1 | DIET | Basal Diet | STANDARD | 46 | XYZ | TS | 1 | FEEDREG | Feeding Regimen | AD LIBITUM | TRT | Investigational Therapy or Treatment | Example Compound Name | 51
| 31 | XYZ | TS | 1 |
| TRTV | Treatment Vehicle | SALINE | 5253
| 33 | XYZ | TS | 1 |
| TRTCAS | Primary Treatment CAS Registry Number |
| UNK |
|