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  1. The intent of the Trial Summary (TS) domain is to provide a summary of the study information in dataset format. This is not subject-level data.
  2. For a list of example controlled terms for TSPARM and TSPARMCD, and whether they should be included in a submission. TOBA-509 - Getting issue details... STATUS TSPARM and TSPARMCD are subject to controlled terminology.
  3. TSVAL may have controlled terminology, depending on the value of TSPARMCD. For the controlled terminology list to be applied to TSVAL for a specific TSPARMCD.
  4. TS allows for 1 TSVAL value to span multiple variables (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. This is similar to the conventions used in the Comments (CO) domain to accommodate COVAL values longer than 200 characters. TS and CO are special-purpose domains that allow additional TSVAL/COVAL variables to be added to the dataset, in order to accommodate values longer than 200 characters.
  5. For some types of studies, there will be multiple records in the TS dataset for a single parameter, such as GLP type when a study is conducted in such a way that it complies with several GLP guidances. In this case, when TSPARMCD = GLPTYP there may be 2 (or more) records for TSVAL, one with the value "OECD" and the other with the value "FDA."
  6. Use TSGRPID for linking together multiple parameters (e.g., assign a TSGRPID to show a relationship between multiple species to multiple strains, or assign a TSGRPID to show a relationship between several laboratory sites and locations and individual investigators). Note that any parameters with the same GRPID are related.
  7. The TSSEQ variable is required to identify each record as unique, in cases where the same TSPARMCD is used within the dataset. The TSSEQ variable must be populated for all records within the TS dataset.
  8. Some --PARMCD values are available to both the TS and Trial Sets (TX) domains in order to show the relevant information at the appropriate level. If TSPARMCD values do not differ across trial sets, then these should be described in the TS and need not be in the TX domain.
  9. A trial can include more than one genetic toxicology assay (indicated by values for GNTXAID). TOBA-486 - Getting issue details... STATUS TSPARMCD and TSVAL values will likely be different for different values of GNTXAID. 
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