This network is designed to track the electronic signatures on electronic records for a clinical trial in accordance with Title 21 CFR Part 11 of the Code of Federal Regulations.
Various participants in the network have differing levels of access and authority but no single participant group has complete authority. A regulator is able to view the transaction chain to obtain information such as:
- The timeline and chain of events for the creation of a document, review, approval, certification, signature, modification, signature, trasmittal, archival, and destruction.
- Participant creation (activation), modification, actions taken, authority modified, access level changes, and account removal (deactivated).
This business network is for the Management and Oversight of Clinical Trials. Currently, this is just a framework upon which more features and integrations can be built. There are numerous ways a distributed ledger can be implemented into the Trial Management Procedures. From Regulatory Document version control, electronic signatures, investigational product accountability, Institutional Review Board approvals,subject enrollment logs, temperature reading for IP shipments, training certificates, etc. Excel is still heavily used in the industry due to its simplicity, familiarity, compatibility, and the overall frustration of research staff resulting from an uneccesarily large number of individual systems required for only one protocol.
Currently, this Clinical Research DLT Application is in the infancy stage and merely consists of a framework at this time. The goal of this version was to focus on illustrating the potential larger scale application of the framework by creating a comprehensive foundation that would permit such larger scale implementation.
Participants
Regulator - FDA, Auditors, Regulators
Sponsor - The Clinical Trial Sponsor
TrialManagement - The group or entity repsonsible for the management of the Clinical Trial; typically a CRO.
SiteManagement - The person or group responsible for management of individual Clinical Trial sites. Usually a member of the TrialManagement organization but with oversight for only a subset of the study sites. A "CRA" would be an example of a member of this participant group.
SitePI - The principal investigator for an individual study site. This name will be listed on the FDA 1572 for a clinical trial completed by the clinical trial site prior to initiation of a protocol. Sub-Investigators will be implemented in this group in later version.
SiteResearchStaff - Research staff for a clinical trial site that are not considered to be investigators (PI or sub-Is). These participants will be listed in the Delegation of Authority Log prior to their inclusion in this network.
Assets
Document
Signature
Authority -- maybe
Transactions
Create Participant
Activate Participant
Deactivate Particpant
Assign Participant Permissions
Create Document
Modify Document
Review Document
Approve Document
Certify Document
Retrieve Document
Transmit Document
Archive Document
Create Signature
Certify Signature
Approve Signature
Revoke Signature
Amend Signature
PlaceOrder UpdateOrderStatus ApplicationForVehicleRegistrationCertificate PrivateVehicleTransfer ScrapVehicle UpdateSuspicious ScrapAllVehiclesByColour SetupDemo
Events
PlaceOrderEvent UpdateOrderStatusEvent ScrapVehicleEvent
A PriavteOwner participant would submit a PlaceOrder transaction, through a Manufacturer's application. A Manufacturer would submit an UpdateOrderStatus transaction which would be the Vehicle being manufactured. They would apply for a registration certificate by submitting an ApplicationForVehicleRegistrationCertificate transaction. After the vehicle has been manufactured they would submit a PrivateVehicleTransfer transaction. A Regulator would be able perform oversight over this whole process and submit an UpdateSuspicious transaction to view any suspicious vehicles that may be out of compliance with regulations. A ScrapMerchant would be able to submit a ScrapVehicle or a ScrapAllVehiclesByColour transaction to complete the lifecycle of a vehicle.
To test this Business Network Definition in the Test tab:
Submit a SetupDemo transaction:
{
"$class": "org.acme.vehicle.lifecycle.SetupDemo"
}
This transaction populates the Participant Registries with three Manufacturer participants, twenty-three PrivateOwner participants and a Regulator participant. The Vehicle Asset Registry will have thirteen Vehicle assets.
Submit a PlaceOrder transaction:
{
"$class": "org.acme.vehicle.lifecycle.manufacturer.PlaceOrder",
"orderId": "1234",
"vehicleDetails": {
"$class": "org.vda.VehicleDetails",
"make": "Arium",
"modelType": "Gamora",
"colour": "Sunburst Orange"
},
"manufacturer": "resource:org.acme.vehicle.lifecycle.manufacturer.Manufacturer#Arium",
"orderer": "resource:org.acme.vehicle.lifecycle.PrivateOwner#toby"
}
This PlaceOrder transaction creates a new order in the Order Asset Registry. It also emits a PlaceOrderEvent events.
Submit a UpdateOrderStatus transaction:
{
"$class": "org.acme.vehicle.lifecycle.manufacturer.UpdateOrderStatus",
"orderStatus": "SCHEDULED_FOR_MANUFACTURE",
"order": "resource:org.acme.vehicle.lifecycle.manufacturer.Order#1234"
}
This UpdateOrderStatus transaction updates the order status of orderId:1234 in the Order Asset Registry. It also emits a UpdateOrderStatusEvent event.
Congratulations!
This Business Network definition had been used to create demo applications for the PrivateOwner, Manufacturer and Regulator. Find more information here: https://github.com/hyperledger/composer-sample-applications/tree/master/packages/vehicle-lifecycle
This is the "Hello World" of Hyperledger Composer samples, which demonstrates the core functionality of Hyperledger Composer by changing the value of an asset.
This business network defines:
Participant
SampleParticipant
Asset
SampleAsset
Transaction
SampleTransaction
Event
SampleEvent
SampleAssets are owned by a SampleParticipant, and the value property on a SampleAsset can be modified by submitting a SampleTransaction. The SampleTransaction emits a SampleEvent that notifies applications of the old and new values for each modified SampleAsset.
To test this Business Network Definition in the Test tab:
Create a SampleParticipant participant:
{
"$class": "org.acme.sample.SampleParticipant",
"participantId": "Toby",
"firstName": "Tobias",
"lastName": "Hunter"
}
Create a SampleAsset asset:
{
"$class": "org.acme.sample.SampleAsset",
"assetId": "assetId:1",
"owner": "resource:org.acme.sample.SampleParticipant#Toby",
"value": "original value"
}
Submit a SampleTransaction transaction:
{
"$class": "org.acme.sample.SampleTransaction",
"asset": "resource:org.acme.sample.SampleAsset#assetId:1",
"newValue": "new value"
}
After submitting this transaction, you should now see the transaction in the Transaction Registry and that a SampleEvent has been emitted. As a result, the value of the assetId:1 should now be new value in the Asset Registry.
Congratulations!