SEND Trial Sets (TX)

Description

A trial design domain that contains one record for each trial set characteristic including experimental factors, treatment factors, inherent characteristics, or distinct applicant designations. This domain is not subject oriented.

Specification

Assumptions

1. The Trial Sets (TX) domain provides the list of distinct sets of subjects or sources of information (REFIDs) having different experimental factors, product exposure factors, inherent characteristics, or distinct applicant 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 applicant.
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. applicants should consider utilizing values that will sort alphabetically in an order intended by the applicant.
5. The TXPARMCD and TXPARM list may be extended by the applicant as needed to provide the information on experimental factors that differentiate trial sets.
6. 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.
7. 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.
8. In vivo studies:
   1. There should be no planned parameters of interest that could further subdivide a trial set. Each trial set should be assigned to a single group. Each trial set in an in vivo study should be assigned to a single trial arm.
   2. Trial sets should be designed so that each individual subject shall participate in 1 and only 1 trial set.
   3. 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.
   4. The applicant 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.
   5. The TCNTRL parameter must be included if the Trial Set is considered to be a control for the study (or part of a control). This parameter is used to define the type of control (e.g., VEHICLE CONTROL, POSITIVE CONTROL, etc.)
9. In vitro studies:
   1. Each source of information is directly associated with only one trial set. The RELREF dataset establishes relationships between sources of information via the REFID which indirectly establishes relationships between trial sets.
   2. Trial arms do not typically apply to in vitro studies.
   3. A study can include more than one genetic toxicology assay (indicated by values for GNTXAID) but a trial set must be associated with only one assay.
   4. To describe the intervention for in vitro studies use parameter codes such as ITVNAM, ITVTYPE, ITVCONC, ITVCONCU.