LEAN PROTOCOL FOR CLINICAL RESEARCH STUDY SYSTEMS
Techniques are disclosed for digitizing a framework for clinical development. In one example, a computing device comprising a processor and a memory may be configured to perform the techniques. The processor may first define a data model comprising metadata that specifies a data standard representative of requirements for regulatory-compliant exchange of data between entities. The data model may include one or more client objects, where each client object specifying a sequence of a plurality of gates for a process of a clinical research study protocol. Moreover, each gate of the plurality of gates defines one or more conditions for completion of the gate. The processor may express the data model to define the clinical research study protocol. The memory may store the data model.
1 . A method comprising:
defining, by processing circuitry, a data model comprising metadata that specifies a data standard representative of requirements for regulatory-compliant exchange of data between entities,
wherein the data model includes one or more client objects, each client object specifying a sequence of a plurality of gates for a process of a clinical research study protocol,
wherein each gate of the plurality of gates defines one or more conditions for completion of the gate; and
expressing, by the processing circuitry, the data model to define the clinical research study protocol.
2 . The method of claim 1 , wherein the method further comprises:
outputting, by the processing circuitry, an indication that the process of the clinical research study protocol is at a first gate of the sequence of the plurality of gates;
determining, by the processing circuitry, that one or more conditions of the first gate are satisfied;
determining, by the processing circuitry and in response to determining that each of the one or more conditions of the first gate are satisfied, that the first gate is completed;
only after determining that the first gate is completed; outputting an indication that the clinical research study protocol is at a second gate of the sequence of the plurality of gates subsequent to the first gate.
3 . The method of claim 2 ,
wherein determining that one or more conditions of the first gate are satisfied comprises:
receiving, via a user interface application executed by the processing circuitry and from one or more first users, data associated with the first gate;
displaying, via the user interface application and to one or more second users, the data associated with the first gate;
receiving, via the user interface application and from the one or more second users, an indication that the one or more conditions of the first gate are satisfied;
transmitting, by the user interface application and to a microservice executed by the processing circuitry, the indication that the one or more conditions of the first gate are satisfied; and
wherein determining, in response to determining that each of the one or more conditions of the first gate are satisfied, that the first gate is completed comprises:
determining, by the microservice and in response to the indication from the user interface application that the one or more conditions of the first gate are satisfied, that the first gate is completed.
4 . The method of claim 3 , wherein transmitting, by the user interface application and to the microservice, the indication that the one or more conditions of the first gate are satisfied comprises transmitting, by the user interface application and according to a guaranteed messaging protocol, the indication that the one or more conditions of the gate are satisfied.
5 . The method of claim 3 , wherein determining that the first gate is completed comprises:
determining, by the microservice, in response to the indication from the user application that the one or more conditions of the first gate are satisfied, whether a workflow has been completed; and
determining, responsive to determining that the workflow was completed, that the first gate is completed.
6 . The method of claim 1 , further comprising:
outputting, by the processing circuitry, a representation of the sequence of the plurality of gates, wherein the representation of the sequence of the plurality of gates comprises:
a representation of each gate of the sequence of the plurality of gates; and
a representation of each condition of the one or more conditions of each gate of the sequence of the plurality of gates.
7 . The method of claim 6 , wherein the representation of the sequence of the plurality of gates further comprises:
a status of each gate of the sequence of the plurality of gates; and
a status of each condition of the one or more conditions of each gate of the sequence of the plurality of gates.
8 . The method of claim 6 , wherein the representation of the sequence of the plurality of gates comprises a grid representation of each gate of the sequence of the plurality of gates and each condition of the one or more conditions of each gate of the sequence of the plurality of gates.
9 . The method of claim 6 , wherein outputting the representation of the sequence of the plurality of gates comprises outputting, for display on a dashboard of a web browser, the representation of the sequence of the plurality of gates.
10 . The method of claim 1 , wherein each client object specifies a plurality of processes, each process of the plurality of processes comprising an independent sequence of a plurality of gates for the clinical research study protocol.
11 . The method of 10 , wherein the sequence of the plurality of gates further comprises a closing gate for each process of the of the plurality of processes, such that completion of the closing gate for the corresponding process is indicative that the process has completed.
12 . The method of claim 10 , wherein the plurality of processes comprise at least one of:
a process comprising a sequence of a plurality of feasibility and recruitment stages for the clinical research study protocol;
a process comprising a sequence of a plurality of Identification of Medicinal Products (IDMP) or Clinical Decision Rule (CDR) stages for the clinical research study protocol;
a process comprising a sequence of a plurality of risk-based monitoring stages for the clinical research study protocol;
a process comprising a sequence of a plurality of clinical development risk management stages for the clinical research study protocol;
a process comprising a sequence of a plurality of medical standards stages for the clinical research study protocol;
a process comprising a sequence of a plurality of environment for clinical data stages for the clinical research study protocol;
a process comprising a sequence of a plurality of clinical supply mission stages for the clinical research study protocol; or
a process comprising a sequence of a plurality of Clinical Trial Agreement (CTA) submission stages for the clinical research study protocol.
13 . The method of claim 1 , further comprising receiving, by the processing circuitry and from a user, an input defining:
at least one gate of the sequence of the plurality of gates; or
at least one condition of the one or more conditions for at least one gate of the sequence of the plurality of gates.
14 . The method of claim 1 , wherein the data model further includes one or more properties for each of the client objects that specify one or more dynamic sections of the clinical research study protocol that are to be completed prior to completion of at least one gate of the sequence of the plurality of gates.
15 . The method of claim 1 , wherein the data model further includes one or more objectives, endpoints, and schedules that specify one or more static sections of the clinical research study protocol that are to be completed prior to completion of at least one gate of the sequence of the plurality of gates.
16 . The method of claim 1 , wherein the data model further includes a configurable workflow that participates in approval of at least one gate of the sequence of the plurality of gates.
17 . A computing device comprising:
one or more processors configured to:
define, by processing circuitry, a data model comprising metadata that specifies a data standard representative of requirements for regulatory-compliant exchange of data between entities,
wherein the data model includes one or more client objects, each client object specifying a sequence of a plurality of gates for a process of a clinical research study protocol,
wherein each gate of the plurality of gates defines one or more conditions for completion of the gate; and
express the data model to define the clinical research study protocol; and
a memory configured to store the data model.
18 . The computing device of claim 17 , wherein the one or more processors are further configured to:
output an indication that the process of the clinical research study protocol is at a first gate of the sequence of the plurality of gates;
determine that one or more conditions of the first gate are satisfied;
determining, in response to determining that each of the one or more conditions of the first gate are satisfied, that the first gate is completed;
only after determining that the first gate is completed, output an indication that the clinical research study protocol is at a second gate of the sequence of the plurality of gates subsequent to the first gate.
19 . The computing device of claim 18 , wherein the one or more processors are configured, when determining that one or more conditions of the first gate are satisfied, to:
receive, via a user interface application and from one or more first users, data associated with the first gate;
display, via the user interface application and to one or more second users, the data associated with the first gate;
receive, via the user interface application and from the one or more second users, an indication that the one or more conditions of the first gate are satisfied;
transmit, by the user interface application and to a microservice executed by the processing circuitry, the indication that the one or more conditions of the first gate are satisfied; and
wherein determine, in response to determining that each of the one or more conditions of the first gate are satisfied, that the first gate is completed comprises:
determine, by the microservice and in response to the indication from the user interface application that the one or more conditions of the first gate are satisfied, that the first gate is completed.
20 . The computing device of claim 19 , wherein the one or more processors are configured, when transmitting, by the user interface application and to the microservice, the indication that the one or more conditions of the first gate are satisfied, to transmit, by the user interface application and according to a guaranteed messaging protocol, the indication that the one or more conditions of the gate are satisfied.
21 . The computing device of claim 19 , wherein the one or more processors are configured, when determining that the first gate is completed, to:
determine, by the microservice, in response to the indication from the user application that the one or more conditions of the first gate are satisfied, whether a workflow has been completed; and
determine, responsive to determining that the workflow was completed, that the first gate is completed.
22 . The computing device of claim 17 ,
wherein the one or more processors are further configured to output a representation of the sequence of the plurality of gates, and
wherein the representation of the sequence of the plurality of gates comprises:
a representation of each gate of the sequence of the plurality of gates; and
a representation of each condition of the one or more conditions of each gate of the sequence of the plurality of gates.
23 . The computing device of claim 22 , wherein the representation of the sequence of the plurality of gates further comprises:
a status of each gate of the sequence of the plurality of gates; and
a status of each condition of the one or more conditions of each gate of the sequence of the plurality of gates.
24 . The computing device of claim 22 , wherein the representation of the sequence of the plurality of gates comprises a grid representation of each gate of the sequence of the plurality of gates and each condition of the one or more conditions of each gate of the sequence of the plurality of gates.
25 . The computing device of claim 22 , wherein the one or more processors are configured, when outputting the representation of the sequence of the plurality of gates, to output, for display on a dashboard of a web browser, the representation of the sequence of the plurality of gates.
26 . The computing device of claim 17 , wherein each client object specifies a plurality of processes, each process of the plurality of processes comprising an independent sequence of a plurality of gates for the clinical research study protocol.
27 . The computing device of 26 , wherein the sequence of the plurality of gates further comprises a closing gate for each process of the of the plurality of processes, such that completion of the closing gate for the corresponding process is indicative that the process has completed.
28 . The computing device of claim 26 , wherein the plurality of processes comprise at least one of:
a process comprising a sequence of a plurality of feasibility and recruitment stages for the clinical research study protocol;
a process comprising a sequence of a plurality of Identification of Medicinal Products (IDMP) or Clinical Decision Rule (CDR) stages for the clinical research study protocol;
a process comprising a sequence of a plurality of risk-based monitoring stages for the clinical research study protocol;
a process comprising a sequence of a plurality of clinical development risk management stages for the clinical research study protocol;
a process comprising a sequence of a plurality of medical standards stages for the clinical research study protocol;
a process comprising a sequence of a plurality of environment for clinical data stages for the clinical research study protocol;
a process comprising a sequence of a plurality of clinical supply mission stages for the clinical research study protocol; or
a process comprising a sequence of a plurality of Clinical Trial Agreement (CTA) submission stages for the clinical research study protocol.
29 . The computing device of claim 17 , wherein the one or more processors are configured to receive, from the user, the input defining:
at least one gate of the sequence of the plurality of gates; or
at least one condition of the one or more conditions for at least one gate of the sequence of the plurality of gates.
30 . The computing device of claim 17 , wherein the data model further includes one or more properties for each of the client objects that specify one or more dynamic sections of the clinical research study protocol that are to be completed prior to completion of at least one gate of the sequence of the plurality of gates.
31 . The computing device of claim 17 , wherein the data model further includes one or more objectives, endpoints, and schedules that specify one or more static sections of the clinical research study protocol that are to be completed prior to completion of at least one gate of the sequence of the plurality of gates.
32 . The computing device of claim 17 , wherein the data model further includes a configurable workflow that participates in approval of at least one gate of the sequence of the plurality of gates.
33 . A non-transitory, computer-readable medium comprising instructions that, when executed, are configured to cause processing circuitry to:
define a data model comprising metadata that specifies a data standard representative of requirements for regulatory-compliant exchange of data between entities,
wherein the data model includes one or more client objects, each client object specifying a sequence of a plurality of gates for a process of a clinical research study protocol,
wherein each gate of the plurality of gates defines one or more conditions for completion of the gate; and
express the data model to define the clinical research study protocol.