Procedure Agents
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Unique identifier for a study. Controlled Terms or Format (if applicable): NA
text
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain. Controlled Terms or Format (if applicable): AG
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Controlled Terms or Format (if applicable): NA
integer
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Used to tie together a block of related records in a single domain for a subject. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sponsor-defined reference number. Perhaps pre-printed 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. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Identifier used to link related records across domains.This may be a one-to-one or a one-to-many relationship. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Identifier used to link related records across domains.This will usually be a many-to-one relationship. Controlled Terms or Format (if applicable): NA
Role: Topic CDISC Notes (for domains) Description (for General Classes): Verbatim medication name that is either pre-printed or collected on a CRF. Controlled Terms or Format (if applicable): NA
Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): If AGTRT is modified to facilitate coding, then AGMODIFY will contain the modified text. Controlled Terms or Format (if applicable): NA
Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): Used to define a category of agent. Examples: "CHALLENGE AGENT", or "PET TRACER". Controlled Terms or Format (if applicable): NA
Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): Further categorization of agent. Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Used to indicate whether ("Y"/null) information about the use of a specific agent was solicited on the CRF. Controlled Terms or Format (if applicable): (NY), not extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): When the use of specific agent is solicited, AGOCCUR is used to indicate whether or not ("Y"/"N") use of the agent occurred. Values are null for agents not specifically solicited. Controlled Terms or Format (if applicable): (NY), not extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Used to indicate that a question about a pre-specified agent was not answered. Should be null or have a value of "NOT DONE". Controlled Terms or Format (if applicable): (ND)
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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". Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): 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, then follow assumption 4.1.2.8.3 or omit AGCLAS. Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): 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, then follow Assumption 4.1.2.8.3, Multiple Values for a Non-Result Qualifier Variable, or omit AGCLASCD. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Amount of AGTRT taken. Controlled Terms or Format (if applicable): NA
float
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Dosing amounts or a range of dosing information collected in text form. Units may be stored in AGDOSU. Example: "200-400", "15-20". Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Units for AGDOSE and AGDOSTXT. Examples: "ng", "mg", or "mg/kg". Controlled Terms or Format (if applicable): (UNIT), extensible
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Dose form for AGTRT. Examples: "TABLET", "AEROSOL". Controlled Terms or Format (if applicable): (FRM), extensible
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Usually expressed as the number of repeated administrations of AGDOSE within a specific time period. Example: "ONCE". Controlled Terms or Format (if applicable): (FREQ), extensible
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Route of administration for AGTRT. Examples: "ORAL". Controlled Terms or Format (if applicable): (ROUTE), extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Planned study day of the visit based upon RFSTDTC in Demographics. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Number that gives the planned order of the Element within the Arm for the Element in which the agent administration started. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Epoch associated with the start date/time of the agent administration started. Controlled Terms or Format (if applicable): (EPOCH), extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): The date/time when administration of the treatment indicated by AGTRT and the dosing variables began. Controlled Terms or Format (if applicable): ISO 8601
datetime
Role: Timing CDISC Notes (for domains) Description (for General Classes): The date/time when administration of the treatment indicated by AGTRT and the dosing variables ended. Controlled Terms or Format (if applicable): ISO 8601
Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of start of agent relative to the sponsor-defined RFSTDTC. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of end of agent relative to the sponsor-defined RFSTDTC. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Collected duration for an agent episode. Used only if collected on the CRF and not derived from start and end date/times. Controlled Terms or Format (if applicable): ISO 8601
durationDatetime
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (STENRF), not extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (STENRF), not extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): Identifies the start of the agent as being before or after the sponsor-defined reference time point defined by variable AGSTTPT. Controlled Terms or Format (if applicable): (STENRF), not extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): Description or date/time in ISO 8601 character format of the reference point referred to by AGSTRTPT. Examples: "2003-12-15" or "VISIT 1". Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (STENRF), not extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): Description or date/time in ISO 8601 character format of the reference point referred to by AGENRTPT. Examples: "2003-12-25" or "VISIT 2". Controlled Terms or Format (if applicable): NA