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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 RP STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 RP DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 RP USUBJID Unique Subject Identifier Char Identifier Req Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4 RP RPSEQ Sequence Number Num Identifier Req Sequence number to ensure uniqueness of records within a dataset for a subject (or within a parameter, in the case of the Trial Summary domain). May be any valid number (including decimals) and does not have to start at 1.
5 RP RPGRPID Group ID Char Identifier Perm Optional group identifier, used to link together a block of related records within a subject in a domain. Also used to link together a block of related records in the Trial Summary dataset.
6 RP RPREFID Reference ID Char Identifier Perm Optional internal or external identifier such as lab specimen ID, or UUID for an ECG waveform or a medical image.
7 RP RPSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined identifier. Example: pre-printed line identifier on a case report form.
8 RP RPLNKID Link ID Char Identifier Perm Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship.
9 RP RPLNKGRP Link Group ID Char Identifier Perm Identifier used to link related records across domains. This will usually be a many-to-one relationship.
10 RP RPTESTCD Short Name of Reproductive Test Char C106479 Topic Req Short character value for RPTEST used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters. Examples: "CHILDPOT", "BCMETHOD", "MENARAGE".
11 RP RPTEST Name of Reproductive Test Char C106478 Synonym Qualifier Req Long name For RPTESTCD. Examples: "Childbearing Potential", "Birth Control Method", "Menarche Age".
12 RP RPCAT Category for Reproductive Test Char Grouping Qualifier Perm Used to define a category of topic-variable values. Examples: "No use case to date, but values would be relative to reproduction tests grouping".
13 RP RPSCAT Subcategory for Reproductive Test Char Grouping Qualifier Perm Used to define a further categorization of RPCAT values. Example: "No use case to date, but values would be relative to reproduction tests grouping".
14 RP RPORRES Result or Finding in Original Units Char Result Qualifier Exp Result of the measurement or finding as originally received or collected. Examples: "120", "<1", "POS".
15 RP RPORRESU Original Units Char C71620 Variable Qualifier Perm Unit for RPORRES. Examples: "in", "LB", "kg/L".
16 RP RPSTRESC Character Result/Finding in Std Format Char Result Qualifier Exp Contains the result value for all findings, copied or derived from RPORRES in a standard format or in standard units. RPSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in RPSTRESN. For example, if various tests have results "NONE", "NEG", and "NEGATIVE" in RPORRES, and these results effectively have the same meaning, they could be represented in standard format in RPSTRESC as "NEGATIVE".
17 RP RPSTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Perm Used for continuous or numeric results or findings in standard format; copied in numeric format from RPSTRESC. RPSTRESN should store all numeric test results or findings.
18 RP RPSTRESU Standard Units Char C71620 Variable Qualifier Perm Standardized units used for RPSTRESC and RPSTRESN. Example: "mol/L".
19 RP RPSTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate that a question was not asked or a test was not done, or a test was attempted but did not generate a result. Should be null or have a value of "NOT DONE".
20 RP RPREASND Reason Not Done Char Record Qualifier Perm Reason not done. Used in conjunction with RPSTAT when value is "NOT DONE".
21 RP RPLOBXFL Last Observation Before Exposure Flag Char C66742 Record Qualifier Perm Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
22 RP RPBLFL Baseline Flag Char C66742 Record Qualifier Perm Indicator used to identify a baseline value. Should be "Y" or null. Note that RPBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset.
23 RP RPDRVFL Derived Flag Char C66742 Record Qualifier Perm Used to indicate a derived record. The value should be "Y" or null. Records which represent the average of other records or which do not come from the CRF are examples of records that would be derived for the submission datasets. If RPDRVFL = "Y", then RPORRES may be null, with RPSTRESC and (if numeric) RPSTRESN having the derived value.
24 RP VISITNUM Visit Number Num Timing Exp Clinical encounter number. Numeric version of VISIT, used for sorting.
25 RP VISIT Visit Name Char Timing Perm Protocol-defined description of a clinical encounter.
26 RP VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of VISIT. Should be an integer.
27 RP TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made.
28 RP EPOCH Epoch Char C99079 Timing Perm Epoch associated with the date/time at which the assessment was made.
29 RP RPDTC Date/Time of Collection Char ISO 8601 Timing Exp Collection date and time of an observation.
30 RP RPDY Study Day of Visit/Collection/Exam Num Timing Perm Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
31 RP RPDUR Duration Char ISO 8601 Timing Perm Collected duration of an event, intervention, or finding represented in ISO 8601 character format. Used only if collected on the CRF and not derived.
32 RP RPTPT Planned Time Point Name Char Timing Perm Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose.
33 RP RPTPTNUM Planned Time Point Number Num Timing Perm Numeric version of planned time point used in sorting.
34 RP RPELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm Planned elapsed time in ISO 8601 character format relative to a planned fixed reference (RPTPTREF) such as "Previous Dose" or "Previous Meal". This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval, represented as ISO duration.
35 RP RPTPTREF Time Point Reference Char Timing Perm Description of the fixed reference point referred to by RPELTM, RPTPTNUM, and RPTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
36 RP RPRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time for a fixed reference time point defined by RPTPTREF in ISO 8601 character format.