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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 PR STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 PR DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 PR 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 PR PRSEQ Sequence Number Num Identifier Req Sequence number to ensure uniqueness of records within a dataset for a subject. Should be assigned to be in a consistent chronological order.
5 PR PRGRPID Group ID Char Identifier Perm Used to link together a block of related records within a subject in a domain.
6 PR PRSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined identifier. Example: pre-printed line identifier on a CRF or record identifier defined in the sponsor's operational database.
7 PR PRLNKID Link ID Char Identifier Perm Used to facilitate identification of relationships between records.
8 PR PRLNKGRP Link Group ID Char Identifier Used to facilitate identification of relationships between records.
9 PR PRTRT Reported Name of Procedure Char Topic Req Name of procedure performed, either pre-printed or collected on a CRF.
10 PR PRDECOD Standardized Procedure Name Char Synonym Qualifier Perm Standardized or dictionary-derived name of PRTRT. The sponsor is expected to provide the dictionary name and version used to map the terms in the define.xml external codelist attributes. If an intervention term does not have a decode value in the dictionary then PRDECOD will be null.
11 PR PRCAT Category Char Grouping Qualifier Perm Used to define a category of procedure values.
12 PR PRSCAT Subcategory Char Grouping Qualifier Perm Used to define a further categorization of PRCAT values.
13 PR PRPRESP Pre-specified Char C66742 Record Qualifier Perm Used when a specific procedure is pre-specified on a CRF. Values should be "Y" or null.
14 PR PROCCUR Occurrence Char C66742 Record Qualifier Perm Used to record whether a pre-specified procedure occurred when information about the occurrence of a specific procedure is solicited.
15 PR PRINDC Indication Char Record Qualifier Perm Denotes the indication for the procedure (e.g., why the procedure was performed).
16 PR PRDOSE Dose Num Record Qualifier Perm Amount of PRTRT administered. Not populated when PRDOSTXT is populated.
17 PR PRDOSTXT Dose Description Char Record Qualifier Perm Dosing information collected in text form. Examples: <1, 200-400. Not populated when PRDOSE is populated.
18 PR PRDOSU Dose Units Char C71620 Variable Qualifier Perm Units for PRDOSE, PRDOSTOT, or PRDOSTXT.
19 PR PRDOSFRM Dose Form Char C66726 Variable Qualifier Perm Dose form for PRTRT.
20 PR PRDOSFRQ Dosing Frequency per Interval Char Variable Qualifier Perm Usually expressed as the number of doses given per a specific interval.
21 PR PRDOSRGM Intended Dose Regimen Char Variable Qualifier Perm Text description of the intended schedule or regimen for the procedure.
22 PR PRROUTE Route of Administration Char C66729 Variable Qualifier Perm Route of administration for PRTRT.
23 PR PRLOC Location of Procedure Char C74456 Record Qualifier Perm Anatomical location of a procedure.
24 PR PRLAT Laterality Char C99073 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing laterality.
25 PR PRDIR Directionality Char C99074 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing directionality.
26 PR PRPORTOT Portion or Totality Char C99075 Variable Qualifier Perm Qualifier for anatomical location or specimen further detailing the distribution, which means arrangement of, apportioning of.
27 PR VISITNUM Visit Number Num Timing Perm Clinical encounter number. Numeric version of VISIT, used for sorting.
28 PR VISIT Visit Name Char Timing Perm Protocol-defined description of a clinical encounter.
29 PR VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of VISIT. Should be an integer.
30 PR PRSTDTC Start Date/Time of Procedure Char ISO 8601 Timing Exp Start date/time of the procedure represented in ISO 8601 character format.
31 PR PRENDTC End Date/Time of Procedure Char ISO 8601 Timing Perm End date/time of the procedure represented in ISO 8601 character format.
32 PR PRSTDY Study Day of Start of Procedure Num Timing Perm Study day of start of procedure expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
33 PR PRENDY Study Day of End of Procedure Num Timing Perm Study day of end of procedure expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
34 PR PRDUR Duration of Procedure Char ISO 8601 Timing Perm Collected duration of a procedure represented in ISO 8601 character format. Used only if collected on the CRF and not derived from start and end date/times.
35 PR PRTPT Planned Time Point Name Char Timing Perm Text description of time when a procedure should be performed. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See PRTPTNUM and PRTPTREF.
36 PR PRTPTNUM Planned Time Point Number Num Timing Perm Numerical version of planned time point used in sorting.
37 PR PRELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm Planned elapsed time in ISO 8601 format relative to a planned fixed reference (PRTPTREF). 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.
38 PR PRTPTREF Time Point Reference Char Timing Perm Description of the fixed reference point referred to by PRELTM, PRTPTNUM, and PRTPT.
39 PR PRRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time for a fixed reference time point defined by PRTRTREF in ISO 8601 character format.
40 PR PRSTRTPT Start Relative to Reference Time Point Char Timing Perm Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable PRSTTPT.
41 PR PRSTTPT Start Reference Time Point Char Timing Perm Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by PRSTRTPT. Examples: "2003-12-15" or "VISIT 1".
42 PR PRENRTPT End Relative to Reference Time Point Char Timing Perm Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable PRENTPT.
43 PR PRENTPT End Reference Time Point Char Timing Perm Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by PRENRTPT. Examples: "2003-12-25" or "VISIT 2".