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 recorded as an empty TSVAL and UNKNOWN in the corresponding TSVALNF.
| 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 |
| APPLCNT | Applicant | Example 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 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 |
| AGETXT | Age Text | 6-8 |
| | 27 | XYZ | TS | 1 |
| AGEU | Age Unit | WEEKS |
| | 28 | XYZ | TS | 1 | 1 | STDIR | Study Director | Dr. H. Someone |
| | 29 | XYZ | TS | 1 | 2 | PINV | Principal Investigator | G. Person |
| | 30 | XYZ | TS | 1 |
| TRT | Investigational Therapy or Treatment | Example Compound Name |
| | 31 | XYZ | TS | 1 |
| TRTV | Treatment Vehicle | SALINE |
| | 32 | XYZ | TS | 1 |
| GLPFL | GLP Flag | Y |
| | 33 | XYZ | TS | 1 |
| TRTCAS | Primary Treatment CAS Registry Number |
| UNKNOWN |
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