Asset Properties

the following guide lists each asset and provides a description of any associated properties assets share the common properties described in this guide as well as asset specific properties that relate to their use in a standard or study the type of properties available depends on the type of asset, for example section assets can have a ‘repeating’ property or file assets can include a ‘source’ property to indicate the origin of the file assets can also share common properties such as a name, label or identifier common properties these properties may be found in any of the assets found in this guide label the label property is a non unique classification of the asset, for example “adverse event start date” name indicates the name of the asset, this property should be unique when applied to an asset identifier identifier maps to the unique object identifier (oid) a unique value is added automatically data type specifies the type of data, for example, text, integer, date etc length specifies the maximum number of characters permitted for this data type (does not apply to date, time or datetime) aliases aliases allow you to provide a mapping value to metadata elements in another system assets can have multiple aliases associated description the description tab provides a human readable description of the metadata element you can enter descriptions in multiple languages (locales) therapeutic area this allows you to specify any therapeutic areas that this asset relates to, for example, cardiology clinical stage this allows you to specify any stages in the clinical life cycle this asset relates to for example “study setup”, “submission”, “analysis” and “reporting” etc origins used to capture metadata to define the traceability you can provide a source and type for the origin and attach any relevant files updated displays the last time and date that this asset was updated mandatory relates to the relationship between a section or question on a form mandatory questions or sections must be completed by the end user do not collect if this property allows you to create or associate a condition with an asset visit schedules the visit schedule lists the visits that are included within a study and their expected order a visit schedule does not have any properties other than the visits that it references visits a visit can take place during a study or at any data collection event for example, a study may require two visits; screening and lab assessment available properties repeating indicates that this type of visit can occur repeatedly within the containing study category the study phase appropriate to this type of visit for example, a screening visit, pre treatment, treatment, or follow up visit type indicates the type of visit there are three types of visit scheduled a visit that is expected to occur for each subject as part of the ordinary progress of the study unscheduled an event that is not expected to occur, but may occur as circumstance dictates common an event that is not associated with a particular time for example, adverse event forms which may happen at any point during a study forms forms are used to collect data a series of forms are collected as part of a visit for example, a vital signs form may contain one section, this section may contain the following questions vital signs time systolic blood pressure diastolic blood pressure pulse available properties repeating indicates that a form can occur repeatedly within any containing visit sections a section describes a group of related questions that can be found on a form a form can contain a number of sections for example, a section called demographics may be contained on an informed consent and demographics form the section may contain the following questions sex date of birth race available properties repeating indicates that a section can occur repeatedly within any containing form questions a question is used to capture data that is collected within a study, for example, sex, date of birth, race a section may contain several questions available properties question contains the question text that is presented to the user submission variable submission variables can be selected from a hardcoded list of cdisc standard submission variables, for example, aebodsys range checks defines a range of acceptable values for an item for example, for the variable ‘age’ you could specify a lower range of 16 and an upper range of 65 a question can have multiple range checks type comparator operators can be used to compare values expression operators can be used to provide a machine readable range check severity soft values generate a warning hard values are rejected comparator the following comparator operators can be used to check for strings (values) in the selected question less than less than or equal to greater than greater than or equal to equals not equal to in list not in list error message displayed to the user if the range is not valid units unit assets can be referenced by other assets in ryze conditions conditions are statements that evaluate to true or false, for example "sex is not female" these conditions can be used to specify when a particular metadata element should not be collected, for example do not collect "pregnant?" if the condition "sex is not female" is true conditions can be assigned to any of the following metadata elements to stop them being collected under certain circumstances visits, forms, sections and questions conditions can also be created or associated by using the do not collect if property available properties formal expression formal expressions can be provided to give machine readable implementations of the condition in different systems for example, itemdata\[@oid='i sex']/@value != 'f' enter the language of the expression in the context column, for example xpath datasets a dataset is a collection of data, such as laboratory test results or a subject's medical history datasets can include sdtm, send, adam, proprietary and generic datasets available properties domain a unique two letter code, this field is already completed for some domain collections but is required for some adam datasets, datasets from the general sdtm classes and proprietary datasets class the class that the dataset belongs to for example 'events' structure the structure of the dataset for example 'one record per subject' purpose the purpose of the dataset this can be 'tabulation' or 'analysis' is reference data indicates if the dataset contains subject level data location the location of the xpt file associated with the dataset variables variables are individual data points that relate to an observation or analysis for example, severity, epoch or toxicity available properties display format text value defining how the variable should be displayed for submission, this should be a sas display format values values enable the specification of metadata for a variable and can be used to provide further information describing the possible values for a particular variable selection criteria values may require a selection criteria to be provided the selection criteria defines where that value is relevant selection criteria may also be used with supplemental qualifiers selection criteria are used to describe the conditions under which the definition of a value applies you can define multiple selection criteria and these 'where' conditions are defined by a logical or operation the or operation is dependent on the order of the associated selection criteria for example, if we have terms in the vstestcd variable below that correspond to collected data then the selection criteria can be used to define where that value is collected in the results variable, vsorres available properties where select a variable to check for appropriate values variables can be selected from a list of variables within the asset group the following comparator operators can be used to check for values in the selected variable less than less than or equal to greater than greater than or equal to equals not equal to in list not in list terminologies a terminology defines a set of permitted values, for example, for a question in ryze, there are three types of controlled terminology code/decode each term has a code with an accompanying decode (display) used in forms and edcs enumerated each term has a coded value only used in datasets external this type of terminology links to an external system or dictionary for example, meddra dictionary for more information, see docid\ y9c1cpo07uswogm1yhrl available properties external dictionary links to an external system or dictionary for example, meddra dictionary a terminology can not have a link to an external dictionary and terms associated terms terms are the permitted values associated with a terminology terms can be created for a terminology or existing terms can be associated with a terminology for more information, see docid\ y9c1cpo07uswogm1yhrl methods methods are statements that evaluate to a value, for example, “weight (in kilograms) divided by height squared (in meters)” methods can be used for deriving values such as age and body mass index methods are referenced from question references within a section, allowing a question to have a different method depending on the section it is used in available properties type the type of method for example, computation, imputation, transpose or other formal expression formal expressions can be provided to give machine readable implementations of the method comments comments can be added to provide context or additional information, for example, to help reviewers comments can be associated with multiple assets and may be associated to the following datasets terminologies variables values supplemental qualifiers documents comments can include referenced external documents for external documents, a page reference can be included to specify pages within the document files file assets can be used to reference or store files, for example, a pdf document available properties source specify a file location or place that the file originates from links link assets contain a url link to external files