Design Comments: An act, situated in another model, that is associated with a product reporting related activity. For example, an adverse event or reaction.

UsageNotes: ActRef is used to refer to a full instance of any clinically relevant statement. This also includes reaction instances captured in the base model. The classCode and moodCode of the reference shall have the same values as the act to which reference is being made. According to the context of use the referenced Act may be in the current communication or in a previously communicated message and available from a shared repository

Design Comments: Makes it possible to provide information about the performer of a cited act.

Design Comments: Makes it possible to provide information about the author of a cited act.

Design Comments: Makes it possible to provide information about the location of a cited act.

Design Comments: An act relationship that makes it possible to link a product reporting related act to an act reference. The act reference is used to create a link to acts external to the model, for example to an adverse event or reaction.

Design Comments: The recursive, target Of, association makes it possible to provide information about acts that further define and/or provide information about, acts that are provided in order to shed light on an adverse event or product report. Note, that two similar recursive associations - sourceOf and targetOf - are provided. When it is necessary to join two types of act, the choice of sourceOf or targetOf act relationship is based on the semantics of the act relationship type code used to characterize the association between the two.

Design Comments: An observation associated with an investigation subject which is relevant in the context of the adverse event or product problem report.

Design Comments: A type of procedure that involves a performer introducing or otherwise applying a material into or to the subject (Note the performer and the subject may be the same individual)

Examples: Substance administration may be used to represent

Administration of a measurable quantity of an external force (e.g. radiotherapy)

Administration of a measurable quantity of a substance or force as part of an investigative procedure (e.g. glucose administered in a glucose tolerance test).

Chemotherapy regimens (multiple substance administrations)

Drug prescription

Vaccination record

Tube feeding of a patient

Agricultural field spraying

Oiling a machine

Medicating a herd in a feedlot via food additives

Usage Notes: Substance administration is distinguished from an exposure by the participation of a performer in the act.

The substance administered by a performer physically interacts with the subject or is otherwise "taken in" by the subject during the act of administration.

Detailed information about the supplied substance is represented using the entity class or one of its subtypes.

The performer of a substance administration may be another entity such as a person, device, plant, e.g. poison ivy, animal, e.g. mosquito bite, or it may be the same entity as the subject, as in self-administration.

For purposes of this definition, photons and other models of radiation or light energy are considered substances.

Substances may also include living entities such as live virus vaccines and other materials containing infectious agents, e.g. saliva, blood products, etc. (Note: if the infectious agent is the subject of the substance administration, then the infectious agent is modeled as a "Living Subject.")

Design Comments: A record of something that is being done, has been done, can be done, or is intended or requested to be done. The class is used to represent acts that are not further specialized as an observation, procedure, etc.

Design Comments: An act which acts as an "Organizer of entries." It is Navigational, and is expected to have no semantic content. Knowledge of the section code is not required to interpret contained observations, however, the code will be useful within the adverse event and product problem reporting context. The act represents a heading in a heading structure, or "organizer tree".

Design Comments: The role of assigned entity is played by the responsible organization or person.

Design Comments: A identifier for the responsible person or organization in the context of the assigned entity role.

Design Comments: A code that more fully describes the assigned entity role.

Design Comments: A postal Address for the place.

Design Comments: Provides information about a pause, or cap in time, between a pair of acts assocated via an act relationship.

Design Comments: An act, situated in another model, that is associated with a product reporting related activity. For example, an adverse event or reaction.

UsageNotes: ActRef is used to refer to a full instance of any clinically relevant statement. This also includes reaction instances captured in the base model. The classCode and moodCode of the reference shall have the same values as the act to which reference is being made. According to the context of use the referenced Act may be in the current communication or in a previously communicated message and available from a shared repository

Design Comments: Indicates the sequence to be used in considering or interpreting the relationship of a parent act to the collection of children act related in the same way (that is sharing the same act relationship code value).

Design Comments: An identifier for the act. It is only expected to be used within the context of a single ICSR to provide needed references.

Design Comments: A text description of the observation. The attribute is used when the entire process of making the observation needs to be described. Textual results are captured in observation.value as are all results.

Design Comments: A time expression specifying the focal or operative time of the act.

Design Comments: A code that controls the disclosure of information about this Act, regardless of mood

Design Comments: Information that is assigned or determined by the observation action. Note, the datatype of the observation value is determined by the context.

Design Comments: One or more codes specifying a rough qualitative interpretation of the observation, such as "normal", "abnormal", "below normal", "change up", "resistant", "susceptible", etc.

Design Comments: A linkage between an observation and a reference range providing normal, abnormal, etc. values for observations of that type.

Design Comments: Information used to interpret the outcome of an observation. The Observation Range indicates the values which are to be interpreted as high, low, normal, etc.

Design Comments: If the Boolean indicator is valued, it indicates the specified value is not to be given the stated interpretation.

Design Comments: An identifier for the act. It is only expected to be used within the context of a single ICSR to provide needed references.

Design Comments: A text description of the substance administration.

Design Comments: A code that controls the disclosure of information about this Act, regardless of mood.

Design Comments: An interval of integer numbers stating the minimal and maximal number of repetitions of the Act.

Design Comments: The detailed anatomical site where the medication enters or is applied to the subject.

Design Comments: The the physiological path or route for introducing the therapeutic material into or onto the subject.

Design Comments: The amount of the therapeutic agent or other substance given at one administration event. The dose may be specified either as a physical quantity of active ingredient (e.g., 200 mg) or as the count of administration-units (e.g., tablets, capsules, "eaches").

Design Comments: Identifies the speed with which the substance is introduced into the subject. Expressed as a physical (extensive) quantity over elapsed time (e.g., examples are 100 mL/h, 1 g/d, 40 mmol/h, etc.)

Design Comments: This attribute identifies the quantity that is expected to be consumed over a period of time (with mood="REQ", or that has been consumed (mood="EVN") within a time period. It is used as a verification check on the values specified for other values.

Design Comments: Identifies the maximum total quantity of a therapeutic substance that may be administered to a subject over the period of time.

Design Comments: A code for the administered thing taken from a larger whole. Used if the consumable material is specified as a larger whole but the doseQuantity relates to a specific portion of it rather than the entire consumable material. The ordering system only has a code for "Budesonide Metered Dose Inhaler" but the dose is to be measured in "number of actuations."

Design Comments: Makes it possible to provide information about a product used in a substance administration,

Rationale: The value, CSM, indicates that information related to a product consumed or to be consumed in a substance administration is being provided.

Design Comments: A code specifying the particular kind of Act that the Act-instance represents within its class.

Design Comments: A renderable textual or multimedia description (or reference to a description) of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the Act.

Design Comments: The act relationship is used to capture acts which are recorded as components as an organizer class. This makes it easier to manage the context of acts which are provided within an adverse event or product problem message.