| 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 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 recroded recorded as an empty TSVAL and UNK UNKNOWN in the corresponding TSVALNF.
| Dataset wrap |
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|
| Dataset2 |
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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. |
0| 1 |
| | 15 | XYZ | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology |
20110107| 30 |
| | 16 | XYZ | TS | 1 |
| STCAT | Study Category | TOX |
| | 17 | XYZ | TS | 1 |
SSPONSORSponsoring Organization 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 |
ASOCSTDY27 | XYZ | TS | 1 | Associated Study | Associated pharmacokinetic Study | 28
| | 27 | XYZ | TS | 1 |
| AGEU | Age Unit | WEEKS |
29SPREFID30 | XYZ | TS | 1 | STMON | Sponsor's Monitor | Dr. J. Smith | 31 | XYZ | TS | 1 | Sponsor's Reference ID | SP/StudyID | | 1 | STDIR | Study Director | Dr. H. Someone |
32
| | 29 | 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 | HUMIDT10-Housing Humidity | 39 | XYZ | TS | 1 | HUMIDTU | Housing Humidity Units | % | 40 | XYZ | TS | 1 | LIGHT | Light Cycle | 12 / 12 | 41 | XYZ | TS | 1 | HOUSEGRP | Housing Group | SINGLE42 | 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 | 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 | | 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 |
|