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  1. The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
  2. Each trial set must be identified by a SETCD that is unique within the trial. The SETCD is assigned by the sponsor.
  3. Each trial set should have a SPGRPCD in TXPARMCD with corresponding parameter value under TXVAL. In many cases, more than 1 trial set may be assigned the same group number in the protocol. The inclusion of this parameter facilitates the ability to reference information in the protocol provided and as part of the submission.
  4. The SPGRPCD parameter value may be used for sorting when viewing the data. Sponsors should consider utilizing values that will sort alphabetically in an order intended by the sponsor.
  5. Trial sets should be designed so that each individual subject shall participate in 1 and only 1 trial set.
  6. The ARMCD parameter should be used to associate each trial set with a trial arm as defined in the Trial Arms (TA) table. Each trial set should only have 1 ARMCD parameter, but more than 1 trial set may have the same value of the ARMCD parameter.
  7. The TXPARMCD and TXPARM list may be extended by the sponsor as needed to provide the information on experimental factors that differentiate trial sets.
  8. In general, each set should have a distinct combination of TXPARMCD, TXPARM, and TXVAL whenever possible. If 2 trial sets (identified by distinct SETCD values) have the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain information that distinguishes the sets from each other.
  9. The sponsor may choose to define subjects of different sexes as distinct trial sets if this is appropriate based upon the trial design. Alternatively, if all other parameters are the same, sets can be defined to contain both sexes under the assumption that it is common practice to analyze male and female subjects separately.
  10. The TXPARMCD values marked as "Yes" in the Should Include column in Section 7.4.2, Trial Set Codes, should be included in a well-formed TX domain submission. These TXPARMCD values are expected to occur in almost all studies and may be necessary for clear interpretation of the data package.
  11. Some --PARMCD values are available to both the Trial Summary (TS) and TX domains in order to allow for further description of how those values apply to individual trial sets. However, if the attributes (TXPARMCD) are identical across trial set, including them in TS is sufficient.
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