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.

Identifier used to link related records across domains.This may be a one-to-one or a one-to-many relationship.

Identifier used to link related records across domains.This will usually be a many-to-one relationship.

Verbatim medication name that is either preprinted or collected on a CRF.

If AGTRT is modified to facilitate coding, then AGMODIFY will contain the modified text.

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.

Used to define a category of agent. Examples: "CHALLENGE AGENT", "PET TRACER".

Further categorization of agent.

Used to indicate whether ("Y"/null) information about the use of a specific agent was solicited on the CRF.

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.

Used to indicate that a question about a prespecified agent was not answered. Should be null or have a value of "NOT DONE".

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".

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.

Code 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.

Dosing amounts or a range of dosing information collected in text form. Units may be stored in AGDOSU. Examples: "200-400", "15-20".

Units for AGDOSE and AGDOSTXT. Examples: "ng", "mg", "mg/kg".

Dose form for AGTRT. Examples: "TABLET", "AEROSOL".

Usually expressed as the number of repeated administrations of AGDOSE within a specific time period. Example: "ONCE".

Route of administration for AGTRT. Example: "ORAL".

1. Clinical encounter number. \n 2. Numeric version of VISIT, used for sorting.

1. Protocol-defined description of clinical encounter. \n 2. May be used in addition to VISITNUM and/or VISITDY.

Planned study day of the visit based upon RFSTDTC in Demographics.

Number that gives the planned order of the element within the arm for the element in which the agent administration started.

Epoch associated with the start date/time of the agent administration started.

The date/time when administration of the treatment indicated by AGTRT and the dosing variables began.

The date/time when administration of the treatment indicated by AGTRT and the dosing variables ended.

Study day of start of agent relative to the sponsor-defined RFSTDTC.

Study day of end of agent relative to the sponsor-defined RFSTDTC.

Collected duration for an agent episode. Used only if collected on the CRF and not derived from start and end date/times.

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.

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.

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.

Description or date/time in ISO 8601 character format of the reference point referred to by AGSTRTPT. Examples: "2003-12-15", "VISIT 1".

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.

Description or date/time in ISO 8601 character format of the reference point referred to by AGENRTPT. Examples: "2003-12-25", "VISIT 2".

Procedure Agents(AG) Flashcards

Student preview

43 questions

Show all answers

1.

FLASHCARD QUESTION

Front

STUDYID

Back

Unique identifier for a study.

2.

FLASHCARD QUESTION

Front

DOMAIN

Back

Two-character abbreviation for the domain.

3.

FLASHCARD QUESTION

Front

USUBJID

Back

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

4.

FLASHCARD QUESTION

Front

AGSEQ

Back

Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.

5.

FLASHCARD QUESTION

Front

AGGRPID

Back

Used to tie together a block of related records in a single domain for a subject.

6.

FLASHCARD QUESTION

Front

Structure

Back

One record per recorded intervention occurrence per subject

7.

FLASHCARD QUESTION

Front

Description

Back

An interventions domain that contains the agents administered to the subject as part of a procedure or assessment, as opposed to drugs, medications and therapies administered with therapeutic intent.

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