This class contains demographic observations made about a Patient at a given point of time. Each of the properties in the class exist in the Patient or Person classes. They are repeated here to emphasize that they are point-in-time observations that are needed for a particular report. Note that each of these properties are marked as derived - all of the properties can be calculated from the Patient and Person classes.

Contains information describing any medical devices (whether suspect or concommittant) used by the subject near the time of the adverse event occurred.

This class contains a description (and optionally the content) of any documents held by the sender relevant to this ICSR.

Contains information describing the amount, timing, and route of administration of medicinal products (whether suspect or concommittant) given to or taken by the subject near the time of the adverse event occurred. Corresponds to ICH E2B(R3), G.k.4.r.

Contains information describing any medicinal products (whether suspect or concommittant) given to or taken by the subject near the time of the adverse event occurred. Corresponds to ICH E2B(R3), G.k.

"The primary source of the information is the person who provides the facts about the ICSR. In case of multiple sources, the "Primary Source for Regulatory Purposes" (C.2.r.5) is the person who first reported the facts to the sender. The primary source should be distinguished from senders and retransmitters; the latter is captured in Section C.3." - ICH E2B(R3), C.2.r.

This class contains those properties required for the reporting of product safety-related information (to include product defects) to a regulatory agency. It contains the intersection of the information required for four specific reports: MedWatch 3500, MedWatch 3500A, MedWatch 3500B, and VAERS-1. It is anticipated that subtypes will be created for these individual reports, which will add report-specific properties and constraints. This class is based in the Individual Case Safety Report (ICSR) series of standards. An ICSR is a report of information describing adverse event(s) / reaction(s) experienced by an individual patient. The event(s) / reaction(s) can be related to the administration of one or more medicinal products at a particular point in time. The ICSR can also be used for exchange of other information, such as medication error(s) that do not involve adverse events(s)/reaction(s).

This class is used for literature article(s) that describe individual case(s), but not for articles used for data analysis. From ICH E2B(R3), C.4.r.

This class contains all other case identifiers for this case used in ICH ICSR electronic transmissions.

An assessment of whether the reaction / adverse event may have been caused by or exacerbated by the product cited by the owning ProductEventRelationship class.

This class links a reaction or adverse event with the various medical products (medical devices and/or drugs) that were being used by the patient, and provides an assessment of whether the reaction / adverse event may have been caused by or exacerbated by the product.

This class provides information on the medical product(s) (i.e., medical device or drug) that is either suspected to have caused an adverse event, or that was in use at the time of the adverse event and which may or may not have contributed to the event. Note that this class is used to navigate from the Case Safety Report to observations about the drug or device, which in turn point to the drug and device classes. "The characterisation of the drug role as provided by the primary reporter or, if this information is missing, by the sender. All spontaneous reports should have at least one suspect drug...." - ICH E2B(R3), G.k.1.

This class contains information describing the reaction(s) or adverse event(s) that are being reported.

This class contains information about a person related to the subject of the report (i.e., related to the patient). The ICH implementation guide limits this information to the parent of a child or fetus (usually the mother). However, this class is meant to handle other relevant related persons such as siblings of a child who had an adverse reaction to a vaccine. Note that each of the properties in the class exist in the Patient or Person classes. They are repeated here to emphasize that they are point-in-time observations that are needed for a particular report. Therefore, each of these properties are marked as derived - all of the properties can be calculated from the Patient and Person classes.

This class details "relevant drugs previously administered and which have been stopped before the Adverse Event onset. It does not concern drugs taken concomitantly or drugs which might have potentially been involved in the current reaction(s)/event(s). Medical judgment should be exercised in [determining which drug(s) to include]. Medications that have been stopped might be considered suspect based on the elimination half-life of the drug and the known pharmacodynamic effects of the drug in a particular patient (for example, a patient with known renal or liver impairment).... The information provided here can also include previous experience with similar drugs." - ICH E2B(R3), D.8.r.

This class contains information pertinent to understanding the case (such as diseases, conditions such as pregnancy, surgical procedures, psychological trauma, risk factors, etc.). Medical judgment should be exercised in order to limit the use of this class to those data pertinent to the case. From ICH E2B(R3), D.7.1.r and D.10.7.

The person and/or organization that sent the ICSR. From ICH E2B(R3), C.3.

If the adverse reaction or event occured while the patient was participating in a study (e.g., a clinical trial), this class will contain identifying information about that study.