阅读说明：本技术 Edc系统中数据管理过程的流程自定义方法及系统 (Flow self-defining method and system for data management process in EDC system ) 是由 许海斌 管卫华 于 2021-10-22 设计创作，主要内容包括：本发明提供了一种EDC系统中数据管理过程的流程自定义方法及系统,包括：S1.当接收到用户针对数据点的管理请求时,判断自定义流程是否启用,若是,则执行步骤S2,否则按顺序执行工作流；S2.获取启用流程；S3.查询启用流程的执行条件是否满足,若是,则执行启用流程,否则返回。本方案对数据的校对和审核等流程自由度高,系统使用人员能够按照项目需求设置是否启用相应的步骤,可以满足不同试验的要求；能够通过禁用无关流程提高工作效率,优化项目管理,避免多余数据处理时间和多余劳动成本；每个步骤的顺序及前置条件不固定,具有更高的自由度。(The invention provides a flow self-defining method and a flow self-defining system for a data management process in an EDC system, wherein the flow self-defining method comprises the following steps: s1, when a management request of a user for a data point is received, judging whether a user-defined flow is started, if so, executing a step S2, otherwise, executing a workflow in sequence; s2, acquiring a starting process; and S3, inquiring whether the execution condition of the starting process is met, if so, executing the starting process, and otherwise, returning. According to the scheme, the degree of freedom of the processes such as data proofreading and auditing is high, and system users can set whether to start corresponding steps according to project requirements, so that the requirements of different tests can be met; work efficiency can be improved by forbidding irrelevant processes, project management is optimized, and redundant data processing time and redundant labor cost are avoided; the sequence and precondition of each step are not fixed, and the degree of freedom is higher.)

1. A flow self-defining method of a data management process in an EDC system is characterized by comprising the following steps:

s1, when a management request of a user for a data point is received, judging whether a user-defined flow is started, if so, executing a step S2, otherwise, executing a workflow in sequence;

s2, acquiring a starting process;

and S3, inquiring whether the execution condition of the starting process is met, if so, executing the starting process, and otherwise, returning.

2. The method of claim 1, wherein before step S1, a workflow _ EDC table for recording whether the customized workflow is enabled, a workflow _ action table for recording IDs of respective workflows and whether respective workflows are enabled, a workflow _ process table for recording execution characteristics of respective workflows, and a data _ point table for recording current states of data points are created.

3. The method of claim 2, wherein in step S1, it is determined whether the custom flow is enabled by accessing a workflow _ EDC table.

4. The method of claim 3, wherein in step S2, the ID of the enabled flow is obtained by accessing a workflow _ action table.

5. The method of claim 4, wherein the data _ point table is accessed and the current status of the data point is obtained from the data _ point table before step S3 is executed.

6. The method of claim 5, wherein in step S3, the execution feature status that needs to be satisfied by executing the enabling process is obtained by accessing the workflow _ process table, the execution feature status is compared with the current status of the data point, and the execution condition of the enabling process is determined to be satisfied when the current status meets the execution feature status.

7. The method of claim 6, wherein the execution characteristics of each process include any one or more of data point saved, data empty, data point approved, data point not approved, data point to be collated, data point encoded, data point signed, data point unsigned, data point locked, data point frozen, and data point not frozen.

8. The method of claim 7, wherein the workflow _ process table is associated with the workflow _ action table to obtain the ID of the enabled flow, and the workflow _ process table records the execution feature status that each ID flow needs to satisfy for execution.

9. The method of claim 8, wherein in step S2, one or more enable flows are obtained, and when a plurality of enable flows are obtained, in step S3, each enable flow execution ends and the data _ point table is updated and step S3 is repeated for the remaining enable flows.

10. A flow customization system for data management process in EDC system, comprising a processor for performing the method of any one of claims 1-9.

Technical Field

The invention belongs to the technical field of clinical test data management, and particularly relates to a flow self-defining method and system for a data management process in an EDC system.

Background

Proofreading, auditing and the like are basic functions of an EDC system of a clinical test. At present, a common method for the processes of system proofreading and auditing and the like in an EDC system of a clinical test is a fixed workflow, a data point can be locked through a plurality of fixed steps, and the processes of proofreading, auditing, coding, signing, freezing, locking and the like need to be completed. The flow sequence of the system user for checking and auditing the data points is fixed, and the operation of each flow must be carried out according to the flow sequence built in the system. The steps are in a sequential order, and the execution of each step can be carried out after the completion of the previous step, which has some disadvantages:

1. the data point management has low degree of freedom, each built-in flow of the system must be executed, and if the step is not needed in the project, the step must be executed;

2. each step has a sequence dependence order, and the operation of the next step can be carried out after the completion of the previous step no matter whether the project needs the previous step or not;

3. in addition, generally, different roles in a project are responsible for different processes to perform corresponding operations on data points, but no matter which process a user is responsible for, the user needs to wait for the completion of the operation of a program in a previous sequence before entering the responsible process, so that the process the user is responsible for can be performed.

Disclosure of Invention

The present invention is directed to provide a method and a system for flow customization of a data management process in an EDC system.

In order to achieve the purpose, the invention adopts the following technical scheme:

a flow self-defining method of a data management process in an EDC system comprises the following steps:

s1, when a management request of a user for a data point is received, judging whether a user-defined flow is started, if so, executing a step S2, otherwise, executing a workflow in sequence;

s2, acquiring a starting process;

and S3, inquiring whether the execution condition of the starting process is met, if so, executing the starting process, and otherwise, returning.

In the above flow self-defining method for the data management process in the EDC system, before step S1, a workflow _ EDC table for recording whether the self-defined flow is enabled or not, a workflow _ action table for recording an ID of each flow and whether each flow is enabled or not, a workflow _ process table for recording execution characteristics of each flow, and a data _ point table for recording a current state of a data point are established.

In the above-described flow customization method of the data management process in the EDC system, in step S1, it is determined whether a customization flow is enabled by accessing the workflow _ EDC table.

In the above-described flow customization method of the data management process in the EDC system, in step S2, the ID of the enabled flow is acquired by accessing the workflow _ action table.

In the above-mentioned flow self-defining method of the data management process in the EDC system, the data _ point table is accessed and the current state of the data point is obtained from the data _ point table before the step S3 is executed.

In the above-mentioned method for customizing a data management process flow in an EDC system, in step S3, an execution characteristic state that needs to be satisfied by executing an enable flow is obtained by accessing a workflow _ process table, and the execution characteristic state is compared with a current state of a data point, and when the current state meets the execution characteristic state, it is determined that an execution condition of the enable flow is satisfied.

In the above-mentioned method for customizing a process of a data management process in an EDC system, the execution characteristics of each process include any one or more of a data point saved, a data empty, a data point checked, a data point not checked, a data point to be collated, a data point encoded, a data point signed, a data point not signed, a data point locked, a data point frozen, and a data point not frozen.

In the above flow self-defining method for the data management process in the EDC system, the workflow _ process table is associated with the workflow _ action table to obtain the ID of the enabled flow, and the workflow _ process table records the execution characteristic state that each ID flow needs to satisfy for execution.

In the above-mentioned flow customizing method of data management process in EDC system, in step S2, one or more enable flows are acquired, and when a plurality of enable flows are acquired, in step S3, each enable flow execution is ended and the data _ point table is updated and step S3 is repeated for the remaining enable flows.

A flow self-defining system of data management process in EDC system comprises a processor for executing the method.

The invention has the advantages that:

1. the process freedom degrees such as data proofreading and auditing are high, and system users can set whether to start corresponding steps according to project requirements, so that the requirements of different tests can be met;

2. work efficiency can be improved by forbidding irrelevant processes, project management is optimized, and redundant data processing time and redundant labor cost are avoided;

3. the sequence and precondition of each step are not fixed, and the degree of freedom is higher.

Drawings

Fig. 1 is a flowchart of a flow customization method of a data management process in an EDC system according to the present invention.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and specific embodiments.

The embodiment discloses a flow self-defining method of a data management process in an EDC system, which comprises the following steps:

firstly, a workflow _ edc table for recording whether the user-defined flow is enabled or not, a workflow _ action table for recording the ID of each flow and whether each flow is enabled or not, a workflow _ process table for recording the execution characteristics of each flow, and a data _ point table for recording the current state of a data point are established, and then step S1 is executed.

The format of each database table created is as follows:

workflow _ edc table:

the field is _ active, records whether the custom flow is enabled.

workflow _ action table:

field: recording IDs of all processes, such as IDs of 12 processes including checking, canceling checking, auditing, canceling auditing and the like;

field: the is _ active records whether the flow corresponding to each ID is enabled.

workflow _ process table:

field: the workflow _ process _ ID is associated with 12 processes in the workflow _ action table, the ID of the enabled process can be obtained through the workflow _ action table, the field is used for recording all execution characteristic states related to all ID processes, and the execution characteristics mainly comprise 14 execution characteristics of stored data points, empty data, audited data points, unapproved data points, proofreading data points, encoded data points, signed data points, unsigned data points, locked data points, frozen data points, unfrozen data points and the like;

field: is _ active, recording the execution characteristics related to the enabling process;

field: and a conditions _ flag for recording the state that each relevant execution characteristic needs to satisfy when the enabling process is executed. If the enabled flow is the encoding flow, the is _ active records: the execution characteristics related to the encoding process include that the data points are checked, the data points are not checked, the data points need to be corrected, and the data points are corrected. The conditions _ flag records that the conditions that need to be satisfied for executing the execution characteristics related to the encoding process are: enabling data points to be stored, enabling data to be empty, enabling data points to be audited, enabling data points to be calibrated, and enabling data points to be calibrated.

In this embodiment, the workflow _ process table records the execution characteristics that need to be satisfied by executing each program in the above manner, and in practical application, the workflow _ process table may also record in other forms, which is not limited herein.

data _ point table:

field is _ verified record data Point is verified

Field is _ reviewed records whether the data point has been reviewed

Field is _ coded records whether a data point is coded

Field is _ signed records whether the data point is signed

Field is _ freqen records whether a data point has been frozen

The field is _ locked records whether the data point is locked.

Specifically, as shown in fig. 1, the method flow is as follows:

s1, when a management request of a user for a data point is received, firstly, a workflow _ edc table is inquired, whether a custom flow is started in an is _ active field value is judged, if yes, step S2 is executed, otherwise, a workflow is executed in sequence, and all the flows are fixed and can not be cancelled to be executed in sequence;

s2, acquiring a starting process;

and S3, inquiring whether the execution condition of the starting process is met, if so, executing the starting process, and otherwise, returning.

In step S2, the status bit is _ active field is queried from the workflow _ action table as the enabled flow ID to obtain the ID of the enabled flow.

Further, the data _ point table is accessed and the current state of the data point is obtained from the data _ point table before step S3 is executed. Then, in step S3, the execution characteristics related to the enabled flow are obtained by accessing the is _ active field of the workflow _ process table, and the status that the execution characteristics related to the enabled flow need to be satisfied when the enabled flow is executed is obtained by accessing the conditions _ flag. And then comparing the execution characteristic state with the current state of the data point, and judging that the execution condition of the starting process is met when the current state accords with the execution characteristic state.

For example, for an encoding program, the execution features required to be satisfied are that a data point is enabled to be saved, data is empty and not enabled, a data point is enabled to be audited, a data point is not enabled to be audited, a data point needs to be calibrated and not enabled, a data point is enabled to be calibrated, and if a field is _ verified records that a data point is calibrated in a data _ point table, and a field is _ reviewed records whether a data point is audited or not, it indicates that the current state is in accordance with the execution features.

Further, in step S2, one or more enable flows are acquired, and when a plurality of enable flows are acquired, in step S3, each enable flow execution is ended and the data _ point table is updated and step S3 is repeated for the remaining enable flows. The data point management freedom degree can be improved, the starting process can be selected according to the project requirement, and the flexibility of the process used by the project is improved. And different users can directly enter the flow in charge of the users, so that the data management efficiency is improved.

In addition, the embodiment also discloses a flow self-defining system of the data management process in the EDC system, which comprises a processor used for the method.

In the scheme, each flow state is taken as the execution characteristic of other flows, the workflow _ process table records the execution characteristic related to each flow and the state required to be met by the execution characteristic during the execution of the flow, when a user enters the responsible flow, namely the responsible flow is started, the execution characteristic state of the starting flow is obtained from the workflow _ process table, then the current data point state is searched, the starting flow is directly executed when the current data point state meets the execution characteristic, an operation icon is returned to be used by the user for carrying out the operation related to the flow on the data point, the method is not limited by the fixed program sequence and the preset condition of the traditional workflow, the sequence and the preset condition of each step can be changed according to needs, the method has quite high data management freedom, unnecessary steps are omitted, and the processing efficiency is improved.

The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications or additions may be made to the described embodiments or alternatives may be employed by those skilled in the art without departing from the spirit or ambit of the invention as defined in the appended claims.

Although terms like workflow _ edc table, workflow _ action table, workflow _ process table and data _ point table are used more often herein, the possibility of using other terms is not excluded. These terms are used merely to more conveniently describe and explain the nature of the present invention; they are to be construed as being without limitation to any additional limitations that may be imposed by the spirit of the present invention.