Subject Characteristics
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Unique identifier for a study. Controlled Terms or Format (if applicable): NA
text
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain. Controlled Terms or Format (if applicable): SC
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. Controlled Terms or Format (if applicable): NA
integer
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Used to tie together a block of related records in a single domain for a subject. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Controlled Terms or Format (if applicable): NA
Role: Topic CDISC Notes (for domains) Description (for General Classes): Short name of the measurement, test, or examination described in SCTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SCTESTCD cannot contain characters other than letters, numbers, or underscores. Example: "MARISTAT", "NATORIG". Controlled Terms or Format (if applicable): (SCTESTCD), extensible
Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): Verbatim name of the test or examination used to obtain the measurement or finding. The value in SCTEST cannot be longer than 40 characters. Examples: "Marital Status", "National Origin". Controlled Terms or Format (if applicable): (SCTEST), extensible
Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): Used to define a category of related records. Controlled Terms or Format (if applicable): NA
Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): A further categorization of the subject characteristic. Controlled Terms or Format (if applicable): NA
Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): Result of the subject characteristic as originally received or collected. Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Original unit in which the data were collected. The unit for SCORRES. Controlled Terms or Format (if applicable): (UNIT), extensible
Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): Contains the result value for all findings, copied or derived from SCORRES in a standard format or standard units. SCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SCSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in SCORRES, and these results effectively have the same meaning, they could be represented in standard format in SCSTRESC as "NEGATIVE". Controlled Terms or Format (if applicable): NA
Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): Used for continuous or numeric results or findings in standard format; copied in numeric format from SCSTRESC. SCSTRESN should store all numeric test results or findings. Controlled Terms or Format (if applicable): NA
float
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Standardized unit used for SCSTRESC or SCSTRESN. Controlled Terms or Format (if applicable): (UNIT), extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Used to indicate that the measurement was not done. Should be null if a result exists in SCORRES. Controlled Terms or Format (if applicable): (ND)
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Describes why the observation has no result. Example: "Subject refused". Used in conjunction with SCSTAT when value is "NOT DONE". Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Number that gives the planned order of the Element within the Arm. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Epoch associated with the start date/time at which the assessment was made. Controlled Terms or Format (if applicable): (EPOCH), extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): Collection date and time of the subject characteristic represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601
datetime
Role: Timing CDISC Notes (for domains) Description (for General Classes): 1. Study day of collection, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. Controlled Terms or Format (if applicable): NA