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TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1
Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes
| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
| DOMAIN | Domain Abbreviation | Char | CV | Identifier | Two-character abbreviation for the domain. | Req |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all application or submissions involving the product. | Req | |
| CVSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
| CVGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject and can be used to support relationships within the domain and between domains using RELREC. This is not the treatment group number. | Perm | |
| CVSPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined reference identifier. | Perm | |
| CVTESTCD | Test Short Name | Char | (SCVTSTCD) | Topic | Short name of the measurement, test, or examination described in CVTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in CVTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). CVTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: DIABP, HR, MAP, SYSBP. | Req |
| CVTEST | Test Name | Char | (SCVTST) | Synonym Qualifier | Long name for CVTESTCD. The value in CVTEST cannot be longer than 40 characters. Examples: Diastolic Blood Pressure, Heart Rate, Mean Arterial Pressure, Systolic Blood Pressure. | Req |
| CVPOS | Position of Subject During Test | Char | (POSITION) | Record Qualifier | Position of the subject during the measurement or examination. If the subject is restrained, populate with the position (example SITTING or STANDING); otherwise, populate with UNCONSTRAINED. | Exp |
| CVORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
| CVORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp |
| CVSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from CVORRES in a standard format or standard units. CVSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in CVSTRESN. | Exp | |
| CVSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; contains the numeric form of CVSTRESC. CVSTRESN should store all numeric test results or findings. | Exp | |
| CVSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for CVSTRESC and CVSTRESN. | Exp |
| CVSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in CVORRES. | Perm |
| CVREASND | Reason Not Done | Char | Record Qualifier | Describes why CVSTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm | |
| CVMETHOD | Method of Test | Char | Record Qualifier | Method of the test or examination. Examples: Intravascular, External Cuff. | Exp | |
| CVCSTATE | Consciousness State | Char | (CSTATE) | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS. | Exp |
| CVBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is applicant defined. | Exp |
| CVDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be Y or null. | Perm |
| CVEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm |
| CVREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when CVEXCLFL is Y. | Perm | |
| CVUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm |
| CVDTC | Date/Time of Cardiovascular Test | Char | ISO 8601 datetime or interval | Timing | Date/Time of cardiovascular data collection, in ISO 8601 format. For measurements related to a continuous evaluation interval, CVDTC should be used to indicate the start date/time of that interval. | Exp |
| CVENDTC | End Date/Time of Cardiovascular Test | Char | ISO 8601 datetime or interval | Timing | Date/Time of end of a cardiovascular evaluation interval, in ISO 8601 format. Should be populated when CVDTC represents the start date/time of a continuous evaluation interval. | Perm |
| CVDY | Study Day of Cardiovascular Test | Num | Timing | Study day of cardiovascular data collection, in integer days. For measurements related to a continuous evaluation interval, CVDY can be used to indicate start day of that interval. The algorithm for calculating the day must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
| CVENDY | Study Day of End of Cardiovascular Test | Num | Timing | Study day of the end of a cardiovascular evaluation interval, in integer days. Can be populated when CVDY represents the start day of a continuous evaluation interval. The algorithm for calculating the day must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
| CVNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
| CVNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of CVNOMDY as presented in the study report Examples: Pretreatment, Week 4, Day 28. | Perm | |
| CVTPT | Planned Time Point Name | Char | Timing | Text description of time when data should be collected. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See CVTPTNUM and CVTPTREF. Examples: Predose, 1 Hour Postdose. | Exp | |
| CVTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of CVTPT to aid in sorting. | Exp | |
| CVELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 datetime or interval | Timing | Planned elapsed time (in ISO 8601 format) relative to a fixed time point reference (CVTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by CVTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by CVTPTREF. | Exp |
| CVTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by CVELTM, if used for CVTPTNUM, and CVTPT. It is recommended that CVTPTREF be as descriptive as possible so the reference time point can be inferred without looking at others variables. Example: DAY 1 FIRST DOSE. | Exp | |
| CVRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, CVTPTREF. | Perm |
| CVEVLINT | Evaluation Interval | Char | ISO 8601 | Timing | Length of evaluation interval in ISO 8601 duration format. Used in place of CVSTINT and CVENINT when CVTPTREF is not available. | Perm |
| CVSTINT | Planned Start of Assessment Interval | Char | ISO 8601 | Timing | Planned start of an assessment interval relative to Time Point Reference (CVTPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT1H. | Exp |
| CVENINT | Planned End of Assessment Interval | Char | ISO 8601 | Timing | Planned end of an assessment interval relative to Time Point Reference (CVTPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT2H. | Exp |
Metadata Checks Findings
SDTM & Related IG Metadata Check User Macros FAQ
- Content: For variable CVEVLINT, ISO 8601 is a not a recognized content for Controlled Terms, Codelist, or Format
- Content: For variable CVSTINT, ISO 8601 is a not a recognized content for Controlled Terms, Codelist, or Format
- Content: For variable CVENINT, ISO 8601 is a not a recognized content for Controlled Terms, Codelist, or Format
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