1 Work Configurations

1.1 Custom Attributes

The custom attributes administration function can be accessed through the Administration à Work Config menu and is accessible to administrators of the system.

Once you have clicked on this menu, the system will navigate you to the Custom Attribute List reference page where you will be presented with a list of system entities which are configured for customisation.

1.1.1 What is a Custom Attribute

Customisable entities allows further extension of the dynamic entity framework within PViMS. All clinical elements are fundamentally rendered at run time in context of the associated dataset relationship to a system work plan. However, there are 5 primary entities that are pre-defined within PViMS and these primary entities can be extended through the concept of customisable attributes. These primary entities can be defined as follows: - • Patient – core patient • PatientClinicalEvent – core adverse event history • PatientMedication – core medication history • PatientCondition – core condition history • PatientLabTest – core labs history Each entity contains a set of first class properties (available in all PViMS instances) as well as a set of customisable properties (can be modified per PViMS instance).

1.1.2 Customisation Attributes

Core entities can be extended through the definition of attributes that are effectively appended to the entity itself. The following attribute types can be created: -

· Numeric attribute

· String attribute

· Selection attribute

· DateTime attribute

1.1.3 Core Entities

Entity	Patient
Description	Contains patient demographics. Unique patient record.
First Class Properties (immutable attributes)	· Date of birth · First name · Middle name · Last name · Notes · Globally unique identifier
Second Class Properties (Customised attributes)	String Attributes · Patient File Number · Patient Identity Number · Occupation · Address · Address Line 2 · City · State · Postal Code · Patient Contact Number Selection Attributes · Identity Type · Gender · Marital Status · Employment Status · Language
Entity	PatientClinicalEvent
Description	Contains a history of patient adverse events.
First Class Properties (immutable attributes)	· Onset date · Resolution date · Verbatim description of event · Clinician MedDRA term for event · PV Specialist MedDRA term for event · Globally unique identifier
Second Class Properties (Customised attributes)	Selection Attributes · Outcome · Intensity (Severity) · Grading Scale · Grading · Is the adverse event serious? · Seriousness · Was the AE attributed to one or more drugs? · Was the event reported to national PV? · Condition Ongoing · Route · Days/week · Still On Medication
Entity	PatientCondition
Description	Contains a history of patient conditions
First Class Properties (immutable attributes)	· Start date · End date · Treatment start date · MedDRA term for condition · Comments · Globally unique identifier
Second Class Properties (Customised attributes)	Selection Attributes · Condition Ongoing
Entity	PatientLabTest
Description	Contains a history of patient lab tests
First Class Properties (immutable attributes)	· Test date · Test result · Lab test · Test unit · Lab value · Globally unique identifier
Second Class Properties (Customised attributes)	· None defined
Entity	PatientMedication
Description	Contains a history of patient medications
First Class Properties (immutable attributes)	· Start date · End date · Dose · Dose frequency · Dose unit · Medication · Globally unique identifier
Second Class Properties (Customised attributes)	String Attributes · Indication Selection Attributes · Route · Days/week · Still On Medication · Type of Indication · Indication Judgement · Reason for Stopping · Clinician action taken with regard to medicine suspected of causing AE · Rechallenge

1.1.4 Managing an Entities Custom Attributes

To manage the list of attributes associated to an entity, click the View Custom Attributes Button for the corresponding entity.

The system will navigate you to the view custom attributes page which renders a list of attributes that have been configured for the selected entity.

1.1.5 Adding a New Attribute

To add a new attribute to an entity, click on the Configure New Custom Attribute Button.

The system will navigate you to the custom attribute profile where you will be able to specify the details of the new attribute based on the details listed below.

Entity Name	The name of the entity that the attribute is being added to This field is read only
Category	A free format category that the attribute belongs to This field is mandatory
Attribute Name	The unique name of the attribute This field is mandatory
Attribute Detail	Additional help for the attribute
Attribute Type	The type of attribute being added This field is mandatory
Required	Is the attribute mandatory
Minimum/Maximum value	Numerics only. Range of values to be allowed
Maximum Length	String only. The maximum length of the string
Allow Future/Past Dates Only	DateTime only. Date relationship to current date
Searchable	Should this attribute be searchable (patient and encounter search)

Once information has been entered, click the Save button to submit the request or click the Cancel button to cancel the action and return to the entity.

1.1.6 Editing am Attribute

To modify an attributes set of characteristics, once you have opened the Attribute List, click on the Edit Attribute button alongside the corresponding attribute.

The system will navigate you to the attribute profile where you will be able to modify the attribute accordingly.

Please note, it is not possible to modify the attribute name, type and entity as these characteristics are locked once added.

1.1.7 Modify Selection Values

To modify a selection attributes set of dropdown values, once you have opened the Attribute List, click on the View Selection Items button alongside the corresponding attribute.

The system will navigate you to the attribute profile where you will be able to modify the attribute’s list of selection values accordingly.

1.2 Datasets

The dataset administration function can be accessed through the Administration à Work Config menu and is accessible to administrators of the system.

Once you have clicked on this menu, the system will navigate you to the Dataset List reference page where you will be presented with a list of system datasets.

1.2.1 What is a Dataset

A dataset is effectively a collection of related dataset elements which are grouped within context of one or more dataset categories. An example of a dataset is a TB Chronic Condition Dataset where all clinical elements are related to the treatment of TB on an encounter by encounter basis.

Dataset Elements

Dataset

Dataset Categories

Multiple dataset categories per dataset

Multiple dataset elements per dataset category

1.2.2 Adding a New Dataset

To add a new dataset, click on the Add Dataset Button.

The system will navigate you to the admin page for adding a new dataset. Enter details of the dataset as per the description of each field below.

Dataset Name	The unique name of the dataset This field is mandatory
Help	Additional help information for the dataset
Mandatory Fields Prominent	Used primarily for spontaneous reporting. Group all mandatory fields up front in a separate dataset category

Once information has been entered, click the Save button to submit the request or click the Cancel button to cancel the action and return to the dataset list.

1.2.3 Editing a Dataset

To modify dataset categories and elements within the framework of a dataset, once you have opened the Dataset List, click on the Edit Dataset button alongside the corresponding dataset.

The system will navigate you to the dataset profile where you will be able to modify the dataset accordingly.

1.2.3.1 Add a New Category

To add a new category to the dataset, enter the category name in the category name field and click the Add Category button to add this category to the dataset.

Once you have added the new category, the newly added category will appear in the category list.

Please note, once a category is added to the dataset, elements that have not been allocated as yet may be allocated to that category

1.2.3.2 Configuring a Category

To configure a category, locate the category in the category list and click the Edit Category button to modify this category.

Once you have clicked the button, the system will pop up a category modal form for configuring the category. Enter details of the category as per the description of each field below.

Category	The unique name of the category This field is mandatory
Friendly Name	A friendly name for the category. This is displayed to the user when adding or updating the dataset
Help	Additional help information for the category. This is also displayed to the user.
Acute	Should this category be displayed to acute patients
Chronic	Should this category be displayed to chronic patients? If yes, then a list of chronic conditions may be selected.

Once information has been entered, click the Save button to submit the request or click the Cancel button to cancel the action and return to the dataset.

1.2.3.3 Removing a Category from a Dataset

To remove a category from the dataset, locate the category in the category list and click the Delete Category button to remove this category.

Click the Delete button to delete the category or the Cancel button to return to the dataset.

Please note, you may only delete a category if no element is currently allocated to that category

1.2.3.4 Reordering a Category within a Dataset

To reorder a category within the dataset, locate the category in the category list and either click the up or down arrow accordingly.

Please note, categories will be displayed for data collection in the order specified above.

1.2.3.5 Link an Element to a Category

Linking an element to a category results in that element appearing in that category when adding or modifying the dataset.

To link an element to a category, first select the appropriate category and then select the element for linkage and then click the Add Element button to link the selected element to the selected dataset.

Once the link has been created, the element will appear in the elements list and means it is now available for data collection.

1.2.3.6 De-Link an Element from a Category

De-Linking an element from a category results in that element disappearing from that category when adding or modifying a dataset

To de-link an element from a category, locate the element in the elements list and click the Delete Element button to de-link the selected element from the selected dataset.

Click the Delete button to delink the element from the category or the Cancel button to return to the dataset.

Please note, deleting the element from the category does not remove the element from the database. Instead the element is just delinked from the category and becomes available for allocation to a new category. Unlinked elements are not available for data collection.

1.2.3.7 Reordering an Element within a Category

To reorder an element within the category, locate the element in the element list and either click the up or down arrow accordingly.

Please note, elements will be displayed per category for data collection in the order specified above.

1.3 Dataset Elements

The dataset element administration function can be accessed through the Administration à Work Config menu and is accessible to administrators of the system.

Once you have clicked on this menu, the system will navigate you to the Dataset Element List reference page where you will be presented with a list of existing system dataset elements.

You are able to filter the element list table by entering a search term in the place provided.

1.3.1 What is a Dataset Element?

A dataset element effectively represents an individual and unique clinical element. A dataset element further defines the type of data to be stored for that specific clinical element and inherently defines the data integrity rules that govern the content of that dataset element. An example of a dataset element is the Weight (kg) field which is a numeric field that contains the weight of the patient in kg.

Dataset element framework:

Dataset Element

An individual and unique clinical element

Field

The field definition for the dataset element

1.3.2 Dataset Element Types

An element field type effectively governs the type of data that a dynamic dataset element may implement. The following element types are catered for: · Listbox · DropDownList · AlphaNumericTextbox · NumericTextbox · YesNo · Date · Table

Field Type	Listbox
Description	A list box allows the selection of one or more values from a dropdown list
Attributes	· Specify list of available options
Field Type	DropDownList
Description	A dropdown list allows the selection of one value from a dropdown list
Attributes	· Specify list of available options
Field Type	AlphaNumericTextBox
Description	An alpha numeric text box allows the capturing of free format alphanumeric data
Attributes	· Maximum length of string
Field Type	NumericTextBox
Description	A numeric text box allows the capturing of integer or decimal based data
Attributes	· Number of decimals · Minimum range · Maximum range
Field Type	YesNo
Description	A yes/no field effectively allows the user to select a Boolean value of true or false.
Attributes	· Include drop down list values for Yes and No
Field Type	Date
Description	A date field effectively allows the capturing of a date value. Dates are stored in yyyy-mm-dd format.
Attributes	N/A
Field Type	Table
Description	A table field effectively allows the construction of a sub table within the context of the primary element. A table allows the user to capture multiple rows for the specific primary element, with each row consisting of several sub data elements.
Attributes	N/A

1.3.3 Adding a New Dataset Element

To add a new element, once you have opened the Dataset Element List, click on the Add Element button.

The system will navigate you to a new element page. Enter details of the element as per the description of each field below.

Element Name	The unique name of the element This field is mandatory
OID	The object identifier of the element. Used for extraction to E2B
Default Value	The default value of the element when extracting to E2B
Mandatory	Is this element mandatory when capturing a new spontaneous report
Anonymised	Is this element anonymized when extracting to a report
System	Is this a system defined data element
Rule - Element Can Only Link To Single Dataset	Can this element be linked to multiple datasets
Field Type	The type of element to be created Listbox DropDownList AlphaNumericTextbox NumericTextbox YesNo Date Table System DropDownList.Medicine This field is mandatory

The following information needs to be captured per field type.

AlphaNumericTextbox	Maximum length of the field
NumericTextbox	Number of decimals Minimum and maximum range

Once information has been entered, click the Save button to submit the request or click the Cancel button to cancel the action and return to the element list.

Once the element has been saved, you will be navigated to the newly created element.

1.3.4 Editing a Dataset Element

To edit an existing element, once you have opened the Dataset Element List, click on the Edit Element button alongside the corresponding element.

The system will navigate you to the dataset element page where you are able to modify details of the element or view how the element has been used within the system.

Please note, it is not possible to change the type of field once an element has been created. This is to maintain data integrity. If the field type has to change, it is recommended that the current element be marked as inactive and a new element be created.

1.3.5 Deleting an Existing Element

To delete an existing element, once you have opened the Dataset Element List, click on the Delete Element button when editing an element.

The system will navigate you to a delete element page. Click the Delete button to submit the request or click the Cancel button to cancel the action and return to the element list.

1.3.6 View Distinct Dataset Element Values

Please note, this function allows the administrator to view distinct values that have been collected against this dataset element.

To view a distinct set of element values, once you have opened the Dataset Element List, click on the Edit Element button alongside the corresponding element.

The system will navigate you to the dataset element page where you are able to modify details of the element or view how the element has been used within the system.

Select the Values tab and You will now be presented with a list of distinct values.

1.4 Care Events

The care event administration function can be accessed through the Administration à Work Config menu and is accessible to administrators of the system.

Once you have clicked on this menu, the system will navigate you to the Care Event List reference page where you will be presented with a list of care events.

1.4.1 What is a Care Event?

A care event is essentially the framework for interaction between a health resource and the patient themselves. Clinical data collected for the patient by the health resource is stored in context of an encounter using the framework of the care event. An example of a care event is a Doctor Assessment. A doctor assessment can be defined as the interaction between the doctor and the patient who has presented them self at a facility as they are presently sick. Clinical data collected due to the assessment itself will be stored as part of the patient clinical record as part of their longitudinal history.

Care Event

Multiple roles per care event. A role is the type of health resource that has the ability to interact with the patient in context of the care event

Multiple care events per work plan

Role

1.4.2 Adding a New Care Event

To add a new care event, click on the Add Care Event Button.

The system will navigate you to the admin page for adding a new care event. Enter details of the care event as per the description of each field below.

Description	The unique name of the care event This field is mandatory

Once information has been entered, click the Save button to submit the request or click the Cancel button to cancel the action and return to the care event list.

1.4.3 Editing a Care Event

To modify a care event name, once you have opened the Care Event List, click on the Edit Care Event button alongside the corresponding care event.

The system will navigate you to the care event profile where you will be able to modify the care event name accordingly.

1.4.4 Deleting a Care Event

To delete a care event, once you have opened the Care Event List, click on the Delete Care Event button alongside the corresponding care event.

The system will delete the care event and refresh the care event list accordingly..

Please note, you will not be able to delete care events that have been allocated to a work plan

1.5 Encounter Types

The encounter type administration function can be accessed through the Administration à Work Config menu and is accessible to administrators of the system.

Once you have clicked on this menu, the system will navigate you to the Encounter Type List reference page where you will be presented with a list of encounter types.

1.5.1 Adding a New Encounter Type

To add a new encounter type, click on the Add Encounter Type Button.

The system will navigate you to the admin page for adding a new encounter type. Enter details of the encounter type as per the description of each field below.

Description	The unique name of the encounter type This field is mandatory
Help	Additional help describing the encounter type
Work Plan	The work plan that has been associated to handle the encounter type

Once information has been entered, click the Save button to submit the request or click the Cancel button to cancel the action and return to the encounter type list.

1.5.2 Editing an Encounter Type

To modify an encounter type, once you have opened the Encounter Type List, click on the Edit Encounter Type button alongside the corresponding encounter type.

The system will navigate you to the encounter type profile where you will be able to modify the encounter type accordingly.

1.6 Work Plans

The work plan administration function can be accessed through the Administration à Work Config menu and is accessible to administrators of the system.

Once you have clicked on this menu, the system will navigate you to the Work Plan List reference page where you will be presented with a list of work plans.

1.6.1 What is a Work Plan?

A work plan is essentially the framework for treating a patient in context of any interaction between health resources and the patient themselves. A work plan can be aligned with national guidelines and enforce the collection of critical elements and functions in relation to the work plan itself. An example of a work plan is a Standard Plan for Chronic Assessment. This work plan may be comprised of several care events: - • Triage (nurse collects vitals such as weight, blood pressure, respiratory rate etc.) • Doctor Assessment (doctor assesses patient as per WHO guidelines) • Clinical Evaluations (recording evaluation results)

Work Plan

Dataset Category

Multiple dataset categories per dataset. Each dataset category allocated to a corresponding care event.

Dataset

A dataset is allocated to a work plan. Essentially this means that the dataset categories linked to the dataset are collected through the implementation of the work plan.

Care Event

1.6.2 Adding a New Work Plan

To add a new work plan, click on the Add Work Plan Button.

The system will navigate you to the admin page for adding a new work plan. Enter details of the work plan as per the description of each field below.

Work Plan Name	The unique name of the work plan This field is mandatory
Dataset	The dataset that should be used to render this dataset

Once information has been entered, click the Save button to submit the request or click the Cancel button to cancel the action and return to the work plan list.

1.6.3 Editing a Work Plan

To modify care events and their associated dataset categories elements within the framework of a work plan, once you have opened the Work Plan List, click on the Edit Work Plan button alongside the corresponding dataset.

The system will navigate you to the work plan profile where you will be able to modify the work plan accordingly.

1.6.3.1 Linking a Care Event to a Work Plan

To link a care event to a work plan, select the care event and click the Add Care Event button to add this care event to the work plan.

Once you have added the new care event, the newly added event will appear in the care event list.

Please note, once an event is added to the work plan, categories that have not been allocated as yet may be allocated to that event

1.6.3.2 Removing a Care Event from a Work Plan

To remove a care event from the work plan, locate the care event in the event list and click the Delete Care Event button to remove this event.

Please note, you may only delete a category if no category is currently allocated to that care event

1.6.3.3 Linking a Dataset Category to a Care Event

To link a dataset category to a care event, select the dataset category and care event and click the Add Category button to add this category to this care event.