| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|
| 1 | VISITNUM | Visit Number | Num |
| Timing |
|
| C83101 | An assigned numeric identifier that aligns to the chronological order of a clinical encounter. | Numeric version of VISIT, used for sorting. VISITNUM does not have to be an integer value. | 1, 1.1, 503.75 |
| 2 | VISIT | Visit Name | Char |
| Timing |
|
| C171010 | The label for a protocol-defined clinical encounter. |
|
|
| 3 | VISITDY | Planned Study Day of Visit | Num |
| Timing |
|
| C171011 | The planned study day of a clinical encounter relative to the sponsor-defined reference start date. | Should be an integer. |
|
| 4 | TAETORD | Planned Order of Element Within Arm | Num |
| Timing |
|
| C83438 | An assigned numeric identifier that gives the planned order of the element within the trial arm of the study. | See Section 5.1.1.2, Trial Arms. |
|
| 5 | EPOCH | Epoch | Char |
| Timing |
|
| C71738 | A time period defined in the protocol with a study-specific purpose. | The epoch associated with an observation is determined by the start date or start date and time of the observation, or the date/time of collection if start date/time is not collected (see Section 5.1.1.2, Trial Arms). |
|
| 6 | RPHASE | Repro Phase | Char |
| Timing |
| Not in human clinical trials |
|
| Reproductive phase with which the reproductive stage of the reproductive path is associated. Defined in Trial Paths domain. The RPHASE variable is Required when any Reproductive Phase Day variable is used. |
|
| 7 | RPPLDY | Planned Repro Phase Day of Observation | Num |
| Timing |
| Not in human clinical trials | C170506 | The day within the reproductive phase on which the test or observation was scheduled to occur. | Expressed as an integer. |
|
| 8 | RPPLSTDY | Planned Repro Phase Day of Obs Start | Num |
| Timing |
| Not in human clinical trials | C170508 | The day within the reproductive phase on which the test or observation was scheduled to begin. | Expressed as an integer. |
|
| 9 | RPPLENDY | Planned Repro Phase Day of Obs End | Num |
| Timing |
| Not in human clinical trials | C170507 | The day within the reproductive phase on which the test or observation was scheduled to end. | Expressed as an integer. |
|
| 10 | --DTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing |
|
| C82515 | The date or date and time of the assessment or the specimen or data collection from the subject, represented in a standardized character format. |
|
|
| 11 | --STDTC | Start Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing |
| Not in Findings class domains | C82517 | The start date or date and time of an intervention or event, represented in a standardized character format. | The start date of a Findings class record is stored in the --DTC variable. |
|
| 12 | --ENDTC | End Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing |
|
| C82516 | The end date or date and time of an intervention, event, or finding, represented in a standardized character format. |
|
|
| 13 | --DY | Study Day of Visit/Collection/Exam | Num |
| Timing |
| | C170993 | The number of days from the sponsor-defined reference start date to the date of collection (--DTC), used in study data tabulation. | The sponsor-defined reference start date is RFSTDTC in Demographics. |
|
| 14 | --STDY | Study Day of Start of Observation | Num |
| Timing |
| Not in Findings class domains | C171005 | The number of days from the sponsor-defined reference start date to the start of an intervention or event (--STDTC), used for study data tabulation. | The sponsor-defined reference start date is RFSTDTC in Demographics. |
|
| 15 | --ENDY | Study Day of End of Observation | Num |
| Timing |
|
| C170995 | The number of days from the sponsor-defined reference start date to the end of an intervention, event, or finding (--ENDTC), used for study data tabulation. | The sponsor-defined reference start date is RFSTDTC in Demographics. |
|
| 16 | --NOMDY | Nominal Study Day for Tabulations | Num |
| Timing |
| Not in human clinical trials | C170498 | The nominal study day, relative to the sponsor-defined reference start date, used by data collection and reporting systems for grouping records for observations that may be scheduled to occur on different days into a single study day (e.g., for output on a tabulation report). |
|
|
| 17 | --NOMLBL | Label for Nominal Study Day | Char |
| Timing |
| Not in human clinical trials | C170499 | The name for a protocol-defined nominal study day. | As presented in the study report. |
|
| 18 | --RPDY | Actual Repro Phase Day of Observation | Num |
| Timing |
| Not in human clinical trials | C170504 | The day within the reproductive phase on which the test or observation occurred. | Expressed as an integer. |
|
| 19 | --RPSTDY | Actual Repro Phase Day of Obs Start | Num |
| Timing |
| Not in human clinical trials | C170509 | The day within the reproductive phase on which the test or observation began. | Expressed as an integer. |
|
| 20 | --RPENDY | Actual Repro Phase Day of Obs End | Num |
| Timing |
| Not in human clinical trials | C170505 | The day within the reproductive phase on which the test or observation ended. | Expressed as an integer. |
|
| 21 | --XDY | Day of Obs Relative to Exposure | Num |
| Timing |
| |
| | The actual study day of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment or product. Expressed in integer days relative to RFXSTDTC in Demographics. |
|
| 22 | --XSTDY | Start Day of Obs Relative to Exposure | Num |
| Timing |
| Not in Findings class domains |
|
| The actual study day of the start of an intervention or event, derived relative to the first exposure to any protocol-specified treatment or product. Expressed in integer days relative to RFXSTDTC in Demographics. |
|
| 23 | --XENDY | End Day of Obs Relative to Exposure | Num |
| Timing |
|
|
|
| The actual study day of the end of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment or product. Expressed in integer days relative to RFXSTDTC in Demographics. |
|
| 24 | --CHDY | Day of Obs Rel to Challenge Agent | Num |
| Timing |
|
|
|
| The actual study day of an intervention, event, or finding, derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. |
|
| 25 | --CHSTDY | Start Day of Obs Rel to Challenge Agent | Num |
| Timing |
| Not in Findings class domains |
|
| The actual study day of the start of an intervention or event derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to c ure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. |
|
| 26 | --CHENDY | End Day of Obs Rel to Challenge Agent | Num |
| Timing |
|
|
|
| The actual study day of the end of an intervention, event, or finding derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. |
|
| 27 | --DUR | Collected Duration | Char | ISO 8601 duration | Timing |
|
| C170992 | The collected length of time during which an observation continues, represented in a standardized character format. | Used only if collected on the CRF and not derived. |
|
| 28 | --TPT | Planned Time Point Name | Char |
| Timing |
|
| C171029 | The description of the time when a protocol-defined activity is planned to occur, used for study data tabulation. | This may be represented as an elapsed time relative to a fixed reference point (e.g., time since last dose). See --TPTNUM and --TPTREF. | "PREDOSE", "1 HOUR POST-DOSE" |
| 29 | --TPTNUM | Planned Time Point Number | Num |
| Timing |
|
| C82545 | The numeric identifier of when an observation is planned to occur. | Used in sorting. |
|
| 30 | --ELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing |
|
| C170994 | The interval of time between a planned time point and a fixed reference point, represented in a standardized character format. | The fixed reference point is in --TPTREF. This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval. |
|
| 31 | --TPTREF | Time Point Reference | Char |
| Timing |
|
| C171030 | The description of a time point that acts as a fixed reference for a series of planned time points, used for study data tabulation. | Description of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. | "PREVIOUS DOSE", "PREVIOUS MEAL" |
| 32 | --RFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing |
|
| C82518 | The actual date or date and time of a time point that acts as a fixed reference for a series of planned time points, represented in a standardized character format. | The fixed reference point is in --TPTREF. |
|
| 33 | --STRF | Start Relative to Reference Period | Char |
| Timing |
|
| C82559 | The characterization of the start of an observation relative to the study reference period. | The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics. |
|
| 34 | --ENRF | End Relative to Reference Period | Char |
| Timing |
|
| C82557 | The characterization of the end of an observation relative to the study reference period. | The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics. |
|
| 35 | --EVLINT | Evaluation Interval | Char | ISO 8601 duration or interval | Timing |
|
| C82534 | The planned time interval for which an observation is assessed, represented in a standardized character format. | Usually used with --DTC to describe an interval of this duration that ended at the time represented in --DTC. | "-P2M" to represent a period of the past 2 months as the evaluation interval for a question from a questionnaire. |
| 36 | --EVINTX | Evaluation Interval Text | Char |
| Timing |
|
| C117044 | A textual description of the planned time interval for which an observation is assessed, where the interval is not able to be represented in a standardized character format. | A value that cannot be represented in ISO 8601 format. | "LIFETIME", "LAST NIGHT", "RECENTLY", "OVER THE LAST FEW WEEKS" |
| 37 | --STRTPT | Start Relative to Reference Time Point | Char |
| Timing |
|
| C82560 | The characterization of the start of an observation relative to a reference time point. | The sponsor-defined reference time point is in --STTPT. |
|
| 38 | --STTPT | Start Reference Time Point | Char |
| Timing |
|
| C82575 | The description or date and/or time of a time point that acts as a fixed reference for characterizing the start of an observation. | This is the sponsor-defined reference point referred to by --STRTPT. | "2003-12-15", "VISIT 1" |
| 39 | --ENRTPT | End Relative to Reference Time Point | Char |
| Timing |
|
| C82558 | The characterization of the end of an observation relative to a reference time point. | The sponsor-defined reference time point is in --ENTPT. |
|
| 40 | --ENTPT | End Reference Time Point | Char |
| Timing |
|
| C82574 | The description or date and/or time of a time point that acts as a fixed reference for characterizing the end of an observation. | This is the sponsor-defined reference point referred to by --ENRTPT. | "2003-12-25", "VISIT 2" |
| 41 | MIDS | Disease Milestone Instance Name | Char |
| Timing |
|
|
|
| The name of a specific instance of a Disease Milestone Type (MIDSTYPE) described in the Trial Disease Milestones dataset (see Section 5.1.4.3, Trial Disease Milestones). This should be unique within a subject. Used only in conjunction with RELMIDS and MIDSDTC. |
|
| 42 | RELMIDS | Temporal Relation to Milestone Instance | Char |
| Timing |
|
|
|
| The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS. | "IMMEDIATELY BEFORE", "AT TIME OF", "AFTER" |
| 43 | MIDSDTC | Disease Milestone Instance Date/Time | Char | ISO 8601 datetime or interval | Timing |
|
|
|
| The start date/time of the Disease Milestone Instance Name in MIDS. |
|
| 44 | --STINT | Planned Start of Assessment Interval | Char | ISO 8601 duration | Timing |
| | C117061 | The start of a planned assessment interval relative to a reference time point, represented in a standardized character format. | The reference time point is in --TPTREF. As this variable describes planned timing of an assessment, caution should be exercised when using outside of the Findings class of domains. In an Events or Interventions domain, it may refer to the interval over which --OCCUR is assessed. |
|
| 45 | --ENINT | Planned End of Assessment Interval | Char | ISO 8601 duration | Timing |
|
| C117042 | The end of a planned assessment interval relative to a reference time point, represented in a standardized character format. | The reference time point is in --TPTREF. As this variable describes planned timing of an assessment, caution should be exercised when using outside of the Findings class of domains. In an Events or Interventions domain, it may refer to the interval over which --OCCUR is assessed. |
|
| 46 | --DETECT | Time in Days to Detection | Num |
| Timing | | Not in human clinical trials | C117041 | The number of days from the start of dosing to the earliest detection of a condition or pathogen. |
|
|
| 47 | --PTFL | Point in Time Flag | Char |
| Timing |
| Only in Findings class specimen-based domains: BS, CP, GF, IS, LB, MB, MS, MI, PC, PP |
| | An indication that the specimen was collected at a single point in time. The value is "Y" or null. |
|
| 48 | --PDUR | Planned Duration | Char | ISO 8601 duration | Timing |
| Only in Findings class specimen-based domains: BS, CP, GF, IS, LB, MB, MS, MI, PC, PP |
| | Planned duration of a finding. For a sample-based finding, this could apply to the planned duration of specimen collection. |
|