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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 AG STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 AG DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 AG 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 AG AGSEQ Sequence Number Num Identifier Req Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 AG AGGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
6 AG AGSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number from the procedure or test page.
7 AG AGLNKID 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.
8 AG AGLNKGRP Link Group ID Char Identifier Perm Identifier used to link related records across domains.This will usually be a many-to-one relationship.
9 AG AGTRT Reported Agent Name Char Topic Req Verbatim medication name that is either preprinted or collected on a CRF.
10 AG AGMODIFY Modified Reported Name Char Synonym Qualifier Perm If AGTRT is modified to facilitate coding, then AGMODIFY will contain the modified text.
11 AG AGDECOD Standardized Agent Name Char Synonym Qualifier Perm Standardized or dictionary-derived text description of AGTRT or AGMODIFY. Equivalent to the generic medication name in WHO Drug. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the external codelist element in the Define-XML document. If an intervention term does not have a decode value in the dictionary, then AGDECOD will be left blank.
12 AG AGCAT Category for Agent Char Grouping Qualifier Perm Used to define a category of agent. Examples: "CHALLENGE AGENT", "PET TRACER".
13 AG AGSCAT Subcategory for Agent Char Grouping Qualifier Perm Further categorization of agent.
14 AG AGPRESP AG Pre-Specified Char C66742 Variable Qualifier Perm Used to indicate whether ("Y"/null) information about the use of a specific agent was solicited on the CRF.
15 AG AGOCCUR AG Occurrence Char C66742 Record Qualifier Perm When the use of specific agent is solicited, AGOCCUR is used to indicate whether ("Y"/"N") use of the agent occurred. Values are null for agents not specifically solicited.
16 AG AGSTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate that a question about a prespecified agent was not answered. Should be null or have a value of "NOT DONE".
17 AG AGREASND Reason Procedure Agent Not Collected Char Record Qualifier Perm Describes the reason a response to a question about the occurrence of a procedure agent was not collected. Used in conjunction with AGSTAT when value is "NOT DONE".
18 AG AGCLAS Agent Class Char Variable Qualifier Perm Drug class. May be obtained from coding. When coding to a single class, populate with class value. If using a dictionary and coding to multiple classes, follow guidance in Section 4.2.8.3, Multiple Values for a Non-result Qualifier Variable, or omit AGCLAS.
19 AG AGCLASCD Agent Class Code Char Variable Qualifier Perm Class code corresponding to AGCLAS. Drug class. May be obtained from coding. When coding to a single class, populate with class code. If using a dictionary and coding to multiple classes, follow guidance in Section 4.2.8.3, Multiple Values for a Non-result Qualifier Variable, or omit AGCLASCD.
20 AG AGDOSE Dose per Administration Num Record Qualifier Perm Amount of AGTRT taken.
21 AG AGDOSTXT Dose Description Char Record Qualifier Perm Dosing amounts or a range of dosing information collected in text form. Units may be stored in AGDOSU. Examples: "200-400", "15-20".
22 AG AGDOSU Dose Units Char C71620 Variable Qualifier Perm Units for AGDOSE and AGDOSTXT. Examples: "ng", "mg", "mg/kg".
23 AG AGDOSFRM Dose Form Char C66726 Variable Qualifier Perm Dose form for AGTRT. Examples: "TABLET", "AEROSOL".
24 AG AGDOSFRQ Dosing Frequency per Interval Char C71113 Record Qualifier Perm Usually expressed as the number of repeated administrations of AGDOSE within a specific time period. Example: "ONCE".
25 AG AGROUTE Route of Administration Char C66729 Variable Qualifier Perm Route of administration for AGTRT. Example: "ORAL".
26 AG VISITNUM Visit Number Num Timing Exp 1. Clinical encounter number. \n 2. Numeric version of VISIT, used for sorting.
27 AG VISIT Visit Name Char Timing Perm 1. Protocol-defined description of clinical encounter. \n 2. May be used in addition to VISITNUM and/or VISITDY.
28 AG VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics.
29 AG 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 agent administration started.
30 AG EPOCH Epoch Char C99079 Timing Perm Epoch associated with the start date/time of the agent administration started.
31 AG AGSTDTC Start Date/Time of Agent Char ISO 8601 datetime or interval Timing Perm The date/time when administration of the treatment indicated by AGTRT and the dosing variables began.
32 AG AGENDTC End Date/Time of Agent Char ISO 8601 datetime or interval Timing Perm The date/time when administration of the treatment indicated by AGTRT and the dosing variables ended.
33 AG AGSTDY Study Day of Start of Agent Num Timing Perm Study day of start of agent relative to the sponsor-defined RFSTDTC.
34 AG AGENDY Study Day of End of Agent Num Timing Perm Study day of end of agent relative to the sponsor-defined RFSTDTC.
35 AG AGDUR Duration of Agent Char ISO 8601 duration Timing Perm Collected duration for an agent episode. Used only if collected on the CRF and not derived from start and end date/times.
36 AG AGSTRF Start Relative to Reference Period Char C66728 Timing Perm Describes the start of the agent relative to sponsor-defined 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). If information such as "PRIOR", "ONGOING", or "CONTINUING" was collected, this information may be translated into AGSTRF. \n Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.
37 AG AGENRF End Relative to Reference Period Char C66728 Timing Perm Describes the end of the agent relative to the sponsor-defined 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). If information such as "PRIOR", "ONGOING", or "CONTINUING" was collected, this information may be translated into AGENRF. \n Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.
38 AG AGSTRTPT Start Relative to Reference Time Point Char C66728 Timing Perm Identifies the start of the agent as being before or after the sponsor-defined reference time point defined by variable AGSTTPT. \n Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.
39 AG AGSTTPT Start Reference Time Point Char Timing Perm Description or date/time in ISO 8601 character format of the reference point referred to by AGSTRTPT. Examples: "2003-12-15", "VISIT 1".
40 AG AGENRTPT End Relative to Reference Time Point Char C66728 Timing Perm Identifies the end of the agent as being before or after the reference time point defined by variable AGENTPT. Identifies the end of the agent as being before or after the sponsor-defined reference time point defined by variable AGENTPT. \n Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.
41 AG AGENTPT End Reference Time Point Char Timing Perm Description or date/time in ISO 8601 character format of the reference point referred to by AGENRTPT. Examples: "2003-12-25", "VISIT 2".