Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-206 |
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Excerpt |
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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 registry number is not known; this is recorded as an empty TSVAL and UNKNOWN in the corresponding TSVALNF.
Dataset wrap |
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Dataset2 |
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| 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 3.1.1 |
| 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 |
| SAPPLNCTAPPLCNT | Applicant Organization | 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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