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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, see Section 7.6.2, Trial Summary Codes. 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, see Section 7.6.2, Trial Summary Codes.
  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. The TSPARMCD values marked as "Yes" in the Should Include column in Section 7.6.3, Trial Summary Codes, following the examples should be included in a well-formed TS domain submission. These TSPARMCD values are expected to occur in almost all studies and may be necessary for clear interpretation of the data package. In the event that these values cannot be populated, the TSPARMCD should still be present in the dataset, with an empty (NULL) TSVAL and TSVALNF populated with the appropriate null flavor describing why the value cannot be populated.
  9. 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.

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