...
Assumption: When the experimental unit is derived from the species and strain, such as a cell line, then TESTSYS should be supplied.
In this example, the Trial Summary dataset, ts.xpt, includes many informational fields that may provide context at the study level, for Study 8325064. 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 and this is recorded as an empty TSVAL and UNKNOWN in the corresponding TSVALNF.
| Dataset wrap |
|---|
| Rowcaps |
|---|
Shows | Show two records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP Types apply for this example study. | | Rows 9-12: | TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The Study Director is associated with the Test Facility. | | Rows 18-24: |
Shows | Show that this example study includes two different species of bacteria and a total of five strains. | | Rows 18-22: |
Shows | Show that TSGRPID (TSGRPID = 2) has been used to link the information for one species (Salmonella) with four different strains that are tested in this example study. |
Row Shows | Show that TSGRPID (TSGRPID = 3) has been used to link the information for one species (Escherichia coli) with the strain that is tested in this example study. |
|
| Dataset2 |
|---|
Row | STUDYID | ASSAYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
|---|
1 | 8325064 | Ames | TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
|
|---|
2 | 8325064 | Ames | TS | 2 |
| GLPTYP | Good Laboratory Practice Type | OECD |
|
|---|
3 | 8325064 | Ames | TS | 1 |
| STSTDTC | Study Start Date | 2015-07-29 |
|
|---|
4 | 8325064 | Ames | TS | 1 |
| STITLE | Study Title | The Bacterial Reverse Mutation Test, Study 8325064-1 |
|
|---|
5 | 8325064 | Ames | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 |
|
|---|
6 | 8325064 | Ames | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-09-30 |
|
|---|
7 | 8325064 | Ames | TS | 1 |
| SSPONSOR | Sponsor Organization | Example Sponsor Inc. |
|
|---|
8 | 8325064 | Ames | TS | 1 |
| SPREFID | Sponsor's Study Reference ID |
| NOT APPLICABLE |
|---|
9 | 8325064 | Ames | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name |
|
|---|
10 | 8325064 | Ames | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
|
|---|
11 | 8325064 | Ames | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
|
|---|
12 | 8325064 | Ames | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
|
|---|
13 | 8325064 | Ames | TS | 1 |
| GLPFL | GLP Flag | N |
|
|---|
14 | 8325064 | Ames | TS | 1 |
| ASTD | Assay Standard | OECD Test No. 471 |
|
|---|
15 | 8325064 | Ames | TS | 1 |
| ASTDV | Assay Standard Version | 2020-06-29 |
|
|---|
16 | 8325064 | Ames | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
|
|---|
17 | 8325064 | Ames | TS | 1 |
| SSSTYP | Study Sub Type | Bacterial Reverse Mutation Test |
|
|---|
18 | 8325064 | Ames | TS | 1 | 2 | SPECIES | Species | Salmonella |
|
|---|
19 | 8325064 | Ames | TS | 1 | 2 | STRAIN | Strain | TA98 |
|
|---|
20 | 8325064 | Ames | TS | 1 | 2 | STRAIN | Strain | TA100 |
|
|---|
21 | 8325064 | Ames | TS | 1 | 2 | STRAIN | Strain | TA1535 |
|
|---|
22 | 8325064 | Ames | TS | 1 | 2 | STRAIN | Strain | TA1537 |
|
|---|
23 | 8325064 | Ames | TS | 1 | 3 | SPECIES | Species | Escherichia coli |
|
|---|
24 | 8325064 | Ames | TS | 1 | 3 | STRAIN | Strain | WP2 uvrA pKM101 |
|
|---|
|
|
| Expand |
|---|
| title | Raw Data Table for Study 8325064 |
|---|
|
|
...