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Simple Parallel Design With Recovery |
In this example, the dataset includes many informational fields that may provide context for the study. TSPARMCD = "GLPTYP" is included twice in this example, since both GLP types apply for this study. Also, TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = "1") and records related to the test site (TSGRPID = "2"). The study director is associated with the test facility and the principal investigator is associated with the test site. Finally, the primary treatment CAS Registry Number is not known; this is recroded as an empty TSVAL and UNK in the corresponding TSVALNF.
Dataset wrap |
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Dataset2 |
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Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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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 3.0 |
| 15 | XYZ | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2011-01-07 |
| 16 | XYZ | TS | 1 |
| STCAT | Study Category | TOX |
| 17 | XYZ | TS | 1 |
| SSPONSOR | Sponsoring Organization | Example Sponsor 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 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 |
| 27 | XYZ | TS | 1 |
| AGETXT | Age Text | 6-8 |
| 28 | XYZ | TS | 1 |
| AGEU | Age Unit | WEEKS |
| 29 | XYZ | TS | 1 |
| SPREFID | Sponsor's Reference ID | SP/StudyID |
| 30 | XYZ | TS | 1 |
| STMON | Sponsor's Monitor | Dr. J. Smith |
| 31 | XYZ | TS | 1 | 1 | STDIR | Study Director | Dr. H. Someone |
| 32 | XYZ | TS | 1 | 2 | PINV | Principal Investigator | G. Person |
| 33 | XYZ | TS | 1 |
| IDMETH | Method of Identification | MICROCHIP |
| 34 | XYZ | TS | 1 |
| IACUC | IACUC Number | 1234A |
| 35 | XYZ | TS | 1 |
| WATER | Drinking Water | REVERSE OSMOSIS |
| 36 | XYZ | TS | 1 |
| ENVTEMP | Environmental Temperature | 70-75 |
| 37 | XYZ | TS | 1 |
| ENVTEMPU | Environmental Temperature Units | F |
| 38 | XYZ | TS | 1 |
| HUMIDT | Housing Humidity | 10-30 |
| 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 | WEEKLY |
| 44 | XYZ | TS | 1 |
| MTHTRM | Method of Termination | CO2 |
| 45 | XYZ | TS | 1 |
| DIET | Basal Diet | STANDARD |
| 46 | XYZ | TS | 1 |
| FEEDREG | Feeding Regimen | AD LIBITUM |
| 47 | 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 |
| TRT | Investigational Therapy or Treatment | Example Compound Name |
| 51 | XYZ | TS | 1 |
| TRTV | Treatment Vehicle | SALINE |
| 52 | XYZ | TS | 1 |
| GLPFL | GLP Flag | Y |
| 53 | XYZ | TS | 1 |
| TRTCAS | Primary Treatment CAS Registry Number |
| UNK |
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