see also: Swagger/OpenAPI definition

ORSCF-BillingData Schema Specification

Info
author: ORSCF ("Open Research Study Communication Formats") / T.Korn
license: Apache-2
version: 1.5.0
timestamp: 2021-09-11 12:40

Contents

Model:

chart

StudyExecutionScope

Fields

Name Type Required Fix
StudyExecutionIdentifier (PK) guid YES YES
ExecutingInstituteIdentifier string YES YES
StudyWorkflowName string (100) YES YES
StudyWorkflowVersion string (20) YES YES
ExtendedMetaData string no no

Unique Keys

  • StudyExecutionIdentifier (primary)

StudyExecutionScope.StudyExecutionIdentifier (Field)

a global unique id of a concrete study execution (dedicated to a concrete institute) which is usually originated at the primary CRF or study management system ('SMS')

  • this field represents the identity (PK) of the record
  • after the record has been created, the value of this field must not be changed any more!

StudyExecutionScope.ExecutingInstituteIdentifier (Field)

the institute which is executing the study (this should be an invariant technical representation of the company name or a guid)

  • after the record has been created, the value of this field must not be changed any more!

StudyExecutionScope.StudyWorkflowName (Field)

the official invariant name of the study as given by the sponsor

  • the maximum length of the content within this field is 100 characters.
  • after the record has been created, the value of this field must not be changed any more!

StudyExecutionScope.StudyWorkflowVersion (Field)

version of the workflow

  • the maximum length of the content within this field is 20 characters.
  • after the record has been created, the value of this field must not be changed any more!

StudyExecutionScope.ExtendedMetaData (Field)

optional structure (in JSON-format) containing additional metadata regarding this record, which can be used by 'StudyExecutionSystems' to extend the schema

  • this field is optional, so that 'null' values are supported

Relations

Navigation-Name Role Target-Type Target-Multiplicity
BillableVisits Childs BillableVisit * (multiple)
BillingDemands Childs BillingDemand * (multiple)
Invoices Childs Invoice * (multiple)
BillableVisits (childs of this StudyExecutionScope)

Target: BillableVisit

BillingDemands (childs of this StudyExecutionScope)

Target: BillingDemand

Invoices (childs of this StudyExecutionScope)

Target: Invoice

BillableVisit

Fields

Name Type Required Fix
VisitGuid (PK) guid YES no
StudyExecutionIdentifier (FK) guid YES no
ParticipantIdentifier string (50) YES no
VisitProdecureName string YES no
VisitExecutionTitle string YES no
BillingDemandId (FK) guid no no
InvoiceId (FK) guid no no
ExecutionEndDateUtc datetime no no
SponsorValidationDateUtc datetime no no
ExecutorValidationDateUtc datetime no no

Unique Keys

  • VisitGuid (primary)

BillableVisit.VisitGuid (Field)

a global unique id of a concrete study-visit execution which is usually originated at the primary CRF or study management system ('SMS')

  • this field represents the identity (PK) of the record

BillableVisit.StudyExecutionIdentifier (Field)

a global unique id of a concrete study execution (dedicated to a concrete institute) which is usually originated at the primary CRF or study management system ('SMS')

  • this field is used as foreign key to address the related 'StudyExecution'

BillableVisit.ParticipantIdentifier (Field)

identity of the patient which can be a randomization or screening number (the exact semantic is defined per study)

  • the maximum length of the content within this field is 50 characters.

BillableVisit.VisitProdecureName (Field)

unique invariant name of the visit-procedure as defined in the 'StudyWorkflowDefinition' (originated from the sponsor)

BillableVisit.VisitExecutionTitle (Field)

title of the visit execution as defined in the 'StudyWorkflowDefinition' (originated from the sponsor)

BillableVisit.BillingDemandId (Field)

  • this field is optional, so that 'null' values are supported
  • this field is used as foreign key to address the related 'AssignedBillingDemand'

BillableVisit.InvoiceId (Field)

  • this field is optional, so that 'null' values are supported
  • this field is used as foreign key to address the related 'AssignedInvoice'

BillableVisit.ExecutionEndDateUtc (Field)

  • this field is optional, so that 'null' values are supported

BillableVisit.SponsorValidationDateUtc (Field)

indicates, that the visit is ready to get assigned to a 'BillingDemand' (usually this state is managed by the sponsor) This can only be set after there is a valid 'ExecutionEndDateUtc'

  • this field is optional, so that 'null' values are supported

BillableVisit.ExecutorValidationDateUtc (Field)

indicates, that the visit is ready to get assigned to a 'Invoice' (usually this state is managed by the executor) This can only be set after either the 'SponsorValidationDateUtc' is set (and there is a Demand) nor the states are only managed by the executor, so that the demand-part is completely skipped.

  • this field is optional, so that 'null' values are supported

Relations

Navigation-Name Role Target-Type Target-Multiplicity
BillableTasks Childs BillableTask * (multiple)
StudyExecution Parent StudyExecutionScope 0/1 (optional)
AssignedBillingDemand Lookup BillingDemand 1 (required)
AssignedInvoice Lookup Invoice 1 (required)
BillableTasks (childs of this BillableVisit)

Target: BillableTask

StudyExecution (parent of this BillableVisit)

Target Type: StudyExecutionScope Addressed by: StudyExecutionIdentifier.

AssignedBillingDemand (lookup from this BillableVisit)

Target Type: BillingDemand Addressed by: BillingDemandId.

AssignedInvoice (lookup from this BillableVisit)

Target Type: Invoice Addressed by: InvoiceId.

BillableTask

Fields

Name Type Required Fix
TaskGuid (PK) guid YES YES
VisitGuid (FK) guid YES YES
TaskName string YES YES
TaskExecutionTitle string YES YES

Unique Keys

  • TaskGuid (primary)

BillableTask.TaskGuid (Field)

a global unique id of a concrete study-task execution which is usually originated at the primary CRF or study management system ('SMS')

  • this field represents the identity (PK) of the record
  • after the record has been created, the value of this field must not be changed any more!

BillableTask.VisitGuid (Field)

a global unique id of a concrete study-visit execution which is usually originated at the primary CRF or study management system ('SMS')

  • this field is used as foreign key to address the related 'BillableVisit'
  • after the record has been created, the value of this field must not be changed any more!

BillableTask.TaskName (Field)

unique invariant name of ths task-procedure as defined in the 'StudyWorkflowDefinition' (originated from the sponsor)

  • after the record has been created, the value of this field must not be changed any more!

BillableTask.TaskExecutionTitle (Field)

title of the task execution as defined in the 'StudyWorkflowDefinition' (originated from the sponsor)

  • after the record has been created, the value of this field must not be changed any more!

Relations

Navigation-Name Role Target-Type Target-Multiplicity
BillableVisit Parent BillableVisit 0/1 (optional)
BillableVisit (parent of this BillableTask)

Target Type: BillableVisit Addressed by: VisitGuid.

BillingDemand

created by the sponsor

Fields

Name Type Required Fix
Id (PK) guid YES no
OfficialNumber string YES no
StudyExecutionIdentifier (FK) guid YES no
TransmissionDateUtc datetime no no
CreationDateUtc datetime YES no
CreatedByPerson string YES no

Unique Keys

  • Id (primary)

BillingDemand.Id (Field)

  • this field represents the identity (PK) of the record

BillingDemand.StudyExecutionIdentifier (Field)

  • this field is used as foreign key to address the related 'StudyExecution'

BillingDemand.TransmissionDateUtc (Field)

  • this field is optional, so that 'null' values are supported

Relations

Navigation-Name Role Target-Type Target-Multiplicity
AssignedVisits Referers BillableVisit * (multiple)
StudyExecution Parent StudyExecutionScope 0/1 (optional)
AssignedVisits (refering to this BillingDemand)

Target: BillableVisit

StudyExecution (parent of this BillingDemand)

Target Type: StudyExecutionScope Addressed by: StudyExecutionIdentifier.

Invoice

created by the executor-company

Fields

Name Type Required Fix
Id (PK) guid YES YES
OfficialNumber string YES YES
StudyExecutionIdentifier (FK) guid YES YES
OffcialInvoiceDate datetime YES YES
TransmissionDateUtc datetime no no
CreationDateUtc datetime YES no
CreatedByPerson string YES no
PaymentSubmittedDateUtc datetime no no
PaymentReceivedDateUtc datetime no no

Unique Keys

  • Id (primary)

Invoice.Id (Field)

  • this field represents the identity (PK) of the record
  • after the record has been created, the value of this field must not be changed any more!

Invoice.OfficialNumber (Field)

the invoice number

  • after the record has been created, the value of this field must not be changed any more!

Invoice.StudyExecutionIdentifier (Field)

  • this field is used as foreign key to address the related 'StudyExecution'
  • after the record has been created, the value of this field must not be changed any more!

Invoice.OffcialInvoiceDate (Field)

  • after the record has been created, the value of this field must not be changed any more!

Invoice.TransmissionDateUtc (Field)

  • this field is optional, so that 'null' values are supported

Invoice.PaymentSubmittedDateUtc (Field)

  • this field is optional, so that 'null' values are supported

Invoice.PaymentReceivedDateUtc (Field)

  • this field is optional, so that 'null' values are supported

Relations

Navigation-Name Role Target-Type Target-Multiplicity
AssignedVisits Referers BillableVisit * (multiple)
StudyExecution Parent StudyExecutionScope 0/1 (optional)
AssignedVisits (refering to this Invoice)

Target: BillableVisit

StudyExecution (parent of this Invoice)

Target Type: StudyExecutionScope Addressed by: StudyExecutionIdentifier.