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Comment: removed reference to "treatment"
  1. Subject identification: It is presumed that every subject (i.e., animal) in a study will have a subject identifier (SUBJID). In some cases, a subject may be included in more than 1 study within a submission, and, more commonly, subjects from different studies may have the same subject identifier. To identify a subject uniquely across a submission, a unique identifier (USUBJID) should be assigned and included in all subject-related datasets in the submission.
  2. Arm /treatment identification: When submitting study design information, the values of ARMCD and ARM should be identical to the values defined for that subject in the Subject Elements (SE) dataset. The assignment of values should be consistent, if possible, within a submission.
  3. When additional information is reported about the subjects, this information should be placed in the Subject Characteristics (SC) domain, adding the specific variable as a value in SCTEST. Study design information that does not vary on an individual subject level should be placed in the Trial Sets (TX) table.
  4. BRTHDTC, AGE, and AGETXT: These variables represent 3 levels of precision for the age of the subject, and they should be used according to the information available.
    1. AGE and AGETXT should never both be populated for the same subject. AGEU refers to whichever variable is used.
    2. If information is available about the time of birth for the subject, it should be presented in the variable BRTHDTC in ISO 8601 format, even if this is only partial information (not a complete date of birth).
    3. Data in BRTHDTC should never be derived from another variable. Either this information is collected or this variable should be blank.
    4. If a specific age for the subject is known, but no information regarding date/time of birth is available, then AGE and AGEU should be populated, using the most descriptive/precise unit for the data (e.g., 1 year, 2 months would be AGE = "14" and AGEU = "MONTHS").
    5. AGE and AGEU may be derived using an algorithm involving BRTHDTC and RFSTDTC. In this case, comments in the define file should indicate how AGE was populated.
    6. If only an approximate age is known (e.g., 6-8 weeks), then use AGETXT in conjunction with AGEU (e.g., AGETXT = "6-8" and AGEU = "WEEKS"). The format for AGETXT is number-number (e.g., "6-8").
  5. RFSTDTC, RFENDTC, and BRTHDTC represent date/time values, but they are considered to have a record qualifier role in DM. They are not considered to be timing variables as described in SDTM v1.5, Section 2.2.6, because they are not intended for use in the general observation classes. The subject may have records in other domains with a date/time prior to RFSTDTC and after the RFENDTC.
  6. SPECIES and STRAIN: These variables are permissible and should be used only if different species or strains are used during 1 study. If all the subjects in 1 study are of the same species, strain, and substrain, then this information is collected in the Trial Summary (TS) table. TX can have multiple species and/or strains if they are different by set.
  7. The SETCD variable is to be used to uniquely identify all distinct "groups" or "trial sets." A trial set is a collection of subjects that have a common set of parameters defined in the protocol, where those parameters include experimental parameters, treatment product exposure strategies, inherent characteristics (e.g., strain) parameters, and/or sponsorapplicant-defined attributes (e.g., control group designation). In general, if a distinction between arms does not cause the subjects to be summarized or grouped independently, then the arms should not be reflected as a separate trial set. A subject may belong to 1 and only 1 trial set.
  8. ARM: An arm is a planned path through a study. This path covers the entire time of the study. The group of subjects assigned to an arm is also often colloquially called an "arm." The group of subjects assigned to an arm is also often called a an "treatment exposure group," although it is not necessarily a treatment product exposure group. The same arm can be used to separate subjects into different satellites. For example, use SETCD for assigning main study subjects and TK study subjects.