CN115132312A - Method and system for constructing clinical electronic case report table and electronic equipment - Google Patents
Method and system for constructing clinical electronic case report table and electronic equipment Download PDFInfo
- Publication number
- CN115132312A CN115132312A CN202211068702.4A CN202211068702A CN115132312A CN 115132312 A CN115132312 A CN 115132312A CN 202211068702 A CN202211068702 A CN 202211068702A CN 115132312 A CN115132312 A CN 115132312A
- Authority
- CN
- China
- Prior art keywords
- data
- sub
- information
- field information
- page
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Classifications
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F16/00—Information retrieval; Database structures therefor; File system structures therefor
- G06F16/20—Information retrieval; Database structures therefor; File system structures therefor of structured data, e.g. relational data
- G06F16/21—Design, administration or maintenance of databases
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof
Landscapes
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- General Health & Medical Sciences (AREA)
- Medical Informatics (AREA)
- Primary Health Care (AREA)
- Health & Medical Sciences (AREA)
- Databases & Information Systems (AREA)
- Theoretical Computer Science (AREA)
- Data Mining & Analysis (AREA)
- Physics & Mathematics (AREA)
- General Engineering & Computer Science (AREA)
- General Physics & Mathematics (AREA)
- Medical Treatment And Welfare Office Work (AREA)
Abstract
The present disclosure relates to a method, a system and an electronic device for constructing a clinical electronic case report table, wherein the method is to construct a data template related to the clinical electronic case report table, and comprises the following steps: constructing corresponding field information; defining the structure of the sub-table content, and associating fields defined in the field information; defining a structure of a sub-table log row form; creating a single-page form, and attributing defined fields in field information to the single-page form and/or establishing a dependency relationship between the defined sub-forms and the single-page form; generating visit information, and associating the visit information with a single-page form to obtain a data template; data entry and checking: and inputting and checking the test data of the subject through a data template to generate an electronic case report table of the subject. The system and the electronic equipment are used for executing the method. The method and the device can simplify the construction process of the clinical electronic case report table, facilitate the construction and adjustment of the electronic case report table, and ensure the integrity, reliability and accuracy of data.
Description
Technical Field
The disclosure relates to the technical field of electronic cases, in particular to a method and a system for constructing a clinical electronic case report table and electronic equipment.
Background
The aim of clinical trial Case data management is to obtain high-quality real data, and a well-structured Case Report Form (CRF) can simplify the data processing required for database design, data trial processes and statistical analysis. The traditional paper case report form needs a great deal of personnel for collecting and inputting data, and has more medical risks for the testee.
Based on the development of Electronic data acquisition technology, an Electronic Case Report Form (ECRF) is widely adopted, solves the problems of the traditional paper Case report Form, and has the advantages of timely data entry, real-time data error discovery, research progress acceleration, data quality improvement and the like.
Disclosure of Invention
In order to solve the problems in the prior art, the present disclosure is directed to a method, a system and an electronic device for constructing a clinical electronic case report table. The method and the device can simplify the construction process of the clinical electronic case report table, facilitate the construction and adjustment of the electronic case report table, effectively solve the problems of low data acquisition efficiency, data checking lag, difficult data cleaning and the like, reduce the data management and maintenance cost, and ensure the integrity, reliability and accuracy of the data.
The method for constructing the clinical electronic case report table, which is disclosed by the disclosure, is used for constructing a data template related to the clinical electronic case report table, and comprises the following steps of:
and (3) field information construction: constructing corresponding field information according to the test items;
sub-table predefining: predefining a sub-table based on the field information, defining the structure of the content of the sub-table, and associating the fields defined in the field information;
sub-table information definition: defining the structure of the sub-table log line form as a line number fixed structure or a line number unfixed structure;
single page form creation: creating a single-page form, and attributing defined fields in the field information to the single-page form and/or establishing a dependency relationship between the defined sub-tables and the single-page form;
and (3) visiting information construction: generating visit information based on the visit data, and associating the visit information with the single-page form to obtain the data template;
data entry and checking: and inputting and checking the test data of the subject through the data template to generate an electronic case report table of the subject.
Preferably, in the field information constructing step, the field information includes a field name, a field tag, and a variable type;
the field name is a unique identifier of the field information and comprises one or more characters of letters, numbers and underlines;
the field label is a problem description of field information data acquisition or a help text of the field information;
the variable type is one or more of an option type variable, a text type variable, a numerical type variable, a date type variable, a time type variable, a radio box, a drop-down box and a dynamic search box.
Preferably, the number of the field information is at least two groups, and when the content of the referenced field information is changed after the content of one group of the field information refers to the content of the other group of the field information, the content referring to the field information always displays the latest content of the referenced field information.
Preferably, in the single-page form creating step, the single-page form includes a single-page name, a single-page label, and a single-page type;
the single page name is a unique identifier of the single page form, which comprises one and/or more characters of letters, numbers and underlines;
the single page label is a general description of the single page form;
the single page type indicates that the single page form is in a landscape configuration, a portrait configuration, or a composite configuration,
wherein the single-page form of the landscape structure contains fields defined in the field information;
the single-page form with the longitudinal structure comprises the sub-tables defined in the sub-table information, and the dependency relationship between the defined sub-tables and the single-page form is established;
the single page form of the composite structure comprises the fields defined in the field information and the sub-tables defined in the sub-table information, and establishes the dependency relationship between the defined sub-tables and the single page form.
Preferably, in the step of constructing the visit information, the visit information includes a visit name, a visit label and a visit type;
the access name is a unique identifier of the access information and comprises one and/or a plurality of characters of letters, numbers and underlines;
the visit label is a general description of the visit information;
the visit type is a fixed visit or an unplanned visit.
Preferably, the data entry and check step specifically includes:
s01, inputting and storing test data in the single-page form, performing logic check on the input data, and entering a step S02 if the logic check is passed, otherwise, giving an alarm and interrupting the step;
s02, submitting the input data, logically checking the submitted data, and if the logically checking is passed, entering the 'checking' state of the step S03, otherwise, initiating a question to the target field;
s03, in the 'checking' state, the data in checking is logically checked, the data passing the logical checking can be checked and confirmed, the data failing the logical checking is questioned, when the data confirmed by checking is modified to fail to pass the logical checking, the confirmation state of the data is released and recovered to the unconfirmed state and the questioning is initiated, and the step S04 is executed after all the data are checked and confirmed;
s04, locking the recording state of the data;
s05, freezing the data to enable the data to enter an unmodified state;
and S06, signing and confirming the recorded data, and finishing the construction of the electronic case report table of the patient.
The utility model discloses a clinical electronic case report table construction system, includes:
the field information construction module is used for constructing corresponding field information according to the test items;
a sub-table predefining module for performing sub-table predefining based on the field information, defining a structure of sub-table contents, and associating fields defined in the field information;
the sub-table information definition module is used for defining the structure of the sub-table log line form as a line number fixed structure or a line number unfixed structure;
the single-page form creating module is used for creating a single-page form, attributing defined fields in the field information to the single-page form and/or establishing a dependency relationship between the defined sub-tables and the single-page form;
the visit information construction module is used for generating visit information based on visit data, associating the visit information with the single-page form and obtaining the data template;
and the data entry and check module is used for entering and checking the test data of the subject through the data template to generate an electronic case report table of the subject.
A computer device of the present disclosure comprising a processor and a memory in signal connection, wherein at least one instruction or at least one program is stored in the memory, and when loaded by the processor, the at least one instruction or the at least one program performs the clinical electronic case report form construction method as described above.
A computer readable storage medium of the present disclosure has stored thereon at least one instruction or at least one program which, when loaded by a processor, performs the clinical electronic case report form construction method as described above.
The method, the system and the electronic equipment for constructing the clinical electronic case report table have the advantages that the method, the system and the electronic equipment can generate the electronic case report table with a good structure, can effectively simplify data processing required by database design, data test flow and subsequent statistical analysis, can effectively monitor and manage various factors and links which possibly influence the electronic case report table and data quality results, and can keep reliability and accuracy of data.
Meanwhile, the data template of the electronic case report table comprising the field information, the sub-table, the single-page form and the visit information is constructed, test data can be imported into the data template to generate the corresponding field information, the sub-table, the single-page form and the visit information, functions such as field type selection, field attribute input and the like are combined, the construction process of the electronic case report table can be simplified, dynamic addition and modification of the fields, the sub-table, the single-page form, the visit information and other functions can be realized through a software interface or a data import mode, construction and adjustment of the electronic case report table are facilitated, the problems of low data acquisition efficiency, data verification lag, difficult data cleaning and the like are effectively solved, the data management maintenance cost is reduced, and the integrity, reliability and accuracy of the data are ensured.
Drawings
FIG. 1 is a flowchart illustrating steps of a method for constructing a clinical electronic case report form according to the present embodiment;
fig. 2 is a schematic structural diagram of the computer device according to the embodiment.
Description of reference numerals: 101-processor, 102-memory.
Detailed Description
As shown in fig. 1, the method for constructing a clinical electronic case report table according to the present disclosure generates a corresponding electronic case report table by constructing a data template related to the clinical electronic case report table, so as to directly import test data of a subject through the data template, and specifically, constructing the data template includes the following steps:
and (3) field information construction: according to the test items, corresponding field information, namely fields, or called variables, is constructed, is the minimum element in a database structure, is unique in the database, is uniquely corresponding to a form, and specifically comprises the following information:
a field name which is a unique identifier of field information and is composed of one or more characters of letters, numbers and underlines "_";
the field label is used as a label on the electronic case report form, can also be a help text filled in by the field information, is directly displayed in the electronic case report form and is used for assisting an entry person to fill in entry.
And the variable type is used for indicating the variable type corresponding to the field information, such as one or more of an option type variable, a text type variable, a numerical type variable, a date type variable, a time type variable, a radio box, a drop-down box and a dynamic search box.
The option type variable can be in a single selection form or a check form, and the check form selects the corresponding option when a certain condition is met, and leaves a blank when the condition is not met.
The text type variables are divided into a common text type, a rich text type and a plain text type, wherein the common text type is displayed as a short text box, the characters which can be recorded are within 20 characters, and the allowable recording length needs to be set.
The rich text type is displayed as a long text box, the length of the allowed input character is not more than 1000 characters at most, and when the length of the character is too long, a scroll bar appears, and the allowed input length needs to be set.
The plain text type is in a read-only format and is only used for display and illustration.
The numerical variable is an integer type or a floating point type, and the allowable entry length before and after the decimal point needs to be set.
And the date type variable comprises an accurate type and a fuzzy type, wherein the accurate type needs to input accurate year, month and day, and the fuzzy type allows the UK to be input according to month/day.
The time-based variables also include precision type input HH: MM: SS (24-hour system) and fuzzy type input UK allowed in minutes and seconds.
The radio boxes can be divided into horizontal radio boxes and vertical radio boxes for performing a single selection.
And (4) pulling down the frame.
And the entry condition of the associated field is automatically matched into the search box, and the selection is carried out through a drop-down box.
In a specific embodiment, the number of the field information is at least two groups, the fields are allowed to be dependent on each other, when the content of the field information in one group refers to the content of the field information in the other group, and the content of the referred field information is changed, the content referring to the field information always displays the latest content of the referred field information, namely after the content of the B field information is applied to the A field information, the A field information always displays the latest content of the B field information after the B field information is modified or added, and a cross-form and cross-visit referring mode is allowed.
The sub-table is predefined, the sub-table is predefined based on the field information, the structure of the content of the sub-table is defined, the fields defined in the field information are related, and a plurality of records can be input into the same field in a multi-row mode under the same visit.
Sub-table information definition, which defines the structure of sub-table log row form, and the structure has two types and fixed row number; and under the condition that the line number is not fixed and the line number is not in a fixed format, adding or deleting the line number by an input personnel during data input, and displaying the added lines one by one after expanding.
Single page form creation, single page forms or single page forms and forms. Creating a single-page form, attributing defined fields in the field information to the single-page form and/or establishing a dependency relationship between the defined sub-tables and the single-page form, wherein one single-page form can appear in one visit or a plurality of visits simultaneously, and the method specifically comprises the following steps:
the single page name is a unique identifier of the single page form, which includes one and/or more characters of letters, numbers and underlines "_", has uniqueness in the project database, and does not allow duplication.
The single-page label refers to a general description of the information of the single-page form, such as a classification standard, an adverse event record table and the like. The single page label is displayed directly in the electronic case report form as a single page title, allowing duplication.
A single page type, which indicates that the single page form is in a landscape, portrait, or compound configuration.
The single page form with the horizontal structure only comprises fields defined in the field information, and the fields are displayed one by one.
The single page form with the vertical structure comprises the sub-tables defined in the sub-table information, and the dependency relationship between the sub-tables and the single page form is established.
The single-page form of the composite structure has both the landscape and portrait structures, i.e., contains both the fields defined in the field information and the sub-tables defined in the sub-table information.
And (3) constructing the visit information, generating the visit information based on the visit data, associating the visit information with the single-page form, and obtaining a data template comprising field information, a sub-form, the single-page form and the visit information. Wherein, the visit is called as follow-up, visit or folder, and the visit information specifically includes:
the access name, which is a unique identifier of the access information, comprises one and/or more characters of letters, numbers and underlines "_", and is not allowed to be repeated in the database.
The visit label is the general description of the visit information, for example, the visit label can be set as the visit 1 screening period and is directly displayed in the electronic case report table as the title of the visit information.
The visit type is a fixed visit or an unplanned visit, the visit type can be directly fixed and displayed in an electronic case report table, and the logging personnel can activate/deactivate various visit information according to actual visit conditions.
And the planned visits are not displayed in the electronic case report table in the initial state of the project, and the entry personnel add the data entry according to the actual visit condition, so that one or more planned visits are allowed to be set, and one subject may add one or more different types of planned visits.
The interview information may be associated with one or more created single page forms forming an all electronic case report form data template for the study content.
After the data template is obtained through the steps, the data template can be stored, the data template is loaded in a webpage or program mode when the data template needs to be recorded, and test data is recorded in a mode of system import or manual input by a recording person, wherein the method specifically comprises the following steps: inputting and checking test data of a subject through the data template to generate an electronic case report table of the subject, which specifically comprises the following steps:
s01, inputting and storing test data in the single-page form, performing logic check on the input data, and entering a step S02 if the logic check is passed, otherwise, giving an alarm and interrupting the step;
in the step, the data is in an input/input state, after corresponding test data is input at a corresponding position in the data template, the input data is stored by clicking a 'storage' option, if an input error occurs, the data in the input frame is directly modified and stored again, and the system keeps modification traces after the data is input and stored. When the data is stored, the system automatically checks whether obvious logic or form errors exist, if the logic check is passed, the next step S02 is carried out, otherwise, a warning is given out and the step is interrupted, the data input errors at the corresponding positions are prompted, and the entry personnel are prompted to confirm the modification.
S02, submitting the input data, and logically checking the submitted data, if the logical check is passed, entering the 'checking in' state of the step S03, otherwise, initiating a question to the target field;
in this step, the system performs logical check on the data again when the entered data is submitted, if the current field does not pass the logical check, the system initiates a question on the corresponding field, and if the logical check passes, the data state enters an "under-check" state from an "uncommitted" state.
S03, in the 'checking' state, the data in checking is logically checked, the data passing the logical checking can be checked and confirmed, the question is sent to the data failing the logical checking, when the data passing the logical checking is modified to fail to pass the logical checking, the confirmed state of the data is released and the data is restored to the unconfirmed state and the question is sent, and the step S04 is executed after all the data are checked and confirmed;
in this step, DATA VERIFICATION of corresponding personnel, such as DM and Medical personnel, is performed in a "VERIFICATION in progress" state, after the SDV (SOURCE DATA VERIFICATION, original DATA VERIFICATION) VERIFICATION of each field is completed, and after relevant personnel confirm that the field DATA which is not in question at present is correct, the confirmation option in front of each field in each single-page form is clicked, and the VERIFICATION and confirmation work can be completed. When the verification is confirmed, only the field which is not in question at present can be verified and confirmed, if the confirmed field is modified to be in a questionable state which cannot pass the logical verification, the system can restore the state of the field to an unconfirmed state, and at this time, the field needs to be verified and confirmed again.
S04, locking the recording state of the data; when relevant personnel finish auditing and confirming the visit data and the single-page form data and the data is not questioned in data verification, a data administrator can lock the input data, and in the state, the input authority of the input personnel is locked, but the data can be modified in a questioning mode.
If the data are too many in error, the locking can be cancelled in a cancellation mode, the data are cancelled to an uncommitted state by applying for data modification to a data administrator, and the data can be modified by an entry personnel.
S05, freezing the data to enable the data to enter an unmodified state; after the data are locked and all the data are checked, the data are enabled to enter a frozen state from a locked state by clicking a 'freezing' option, and the data in the frozen state can only be checked and cannot be directly modified. After the data are frozen, the data can be also canceled from the freezing in a canceling way, and the data are canceled to an uncommitted state by applying for data modification to a data manager and can be modified by an entry personnel.
S06, signing and confirming the entered data, completing the construction of the electronic case report table of the patient, after all data are frozen and the entry is confirmed to be accurate, complete and effective, the related personnel can sign and confirm after the identity verification is completed, and the test data entry process of the subject is finished.
In a specific embodiment, the checking process of the entered data corresponding to each field may be set when the data template is constructed, and when the data template is used to record the data of the corresponding field, the entered data needs to perform the checking process set when the data template is constructed.
In the construction process of the data template, the checking process of the field entry data can be customized according to the content and the type of each field, so as to adapt to the data entry checking process of each field.
The method can generate the electronic case report form with a good structure, can effectively simplify data processing required by database design, data test flow and subsequent statistical analysis, can effectively monitor and manage various factors and links which may influence the electronic case report form and data quality results, and can keep the reliability and accuracy of data.
Meanwhile, the data template of the electronic case report table comprising the field information, the sub-table, the single-page form and the visit information is constructed, the corresponding field information, the sub-table, the single-page form and the visit information can be generated by importing the test data into the data template, and the functions of editing and fine-tuning a visual interface are combined, such as field type selection, field attribute input and the like, so that the construction process of the electronic case report table can be simplified, the construction and adjustment of the electronic case report table are facilitated, the problems of low data acquisition efficiency, data checking lag, difficult data cleaning and the like are effectively solved, the data management and maintenance cost is reduced, and the integrity, reliability and accuracy of the data are ensured.
In addition, the method and the device have the advantages that the data entry process is strictly controlled, and the accuracy and the reliability of test data entry can be effectively improved and the risk of errors in the data entry process is reduced through multiple times of logic check and audit confirmation.
The embodiment also provides a clinical electronic case report table construction system, which includes:
the field information construction module is used for constructing corresponding field information according to the test items;
a sub-table predefining module for performing sub-table predefining based on the field information, defining a structure of sub-table contents, and associating fields defined in the field information;
the sub-table information definition module is used for defining the structure of the sub-table log line form as a line number fixed structure or a line number unfixed structure;
the single-page form creating module is used for creating a single-page form, attributing defined fields in the field information to the single-page form and/or establishing a dependency relationship between the defined sub-tables and the single-page form;
the visit information construction module is used for generating visit information based on visit data, associating the visit information with the single-page form and obtaining the data template;
and the data entry and check module is used for entering and checking the test data of the subject through the data template to generate an electronic case report table of the subject.
The clinical electronic case report table construction system of the present embodiment is based on the same inventive concept as the method embodiments described above, and can be understood by referring to the description of the method embodiments above, which is not repeated herein.
As shown in fig. 2, the embodiment further provides a computer device, which includes a processor 101 and a memory 102 connected by bus signals, where the memory 102 stores at least one instruction or at least one program, and when the at least one instruction or the at least one program is loaded by the processor 101, the method for constructing the clinical electronic case report table as described above is executed, the memory 102 can be used to store software programs and modules, and the processor 101 executes various functional applications by executing the software programs and modules stored in the memory 102. The memory 102 may mainly include a program storage area and a data storage area, wherein the program storage area may store an operating system, application programs required for functions, and the like; the storage data area may store data created according to use of the apparatus, and the like. Further, the memory 102 may include high speed random access memory, and may also include non-volatile memory, such as at least one magnetic disk storage device, flash memory device, or other volatile solid state storage device. Accordingly, the memory 102 may also include a memory controller to provide the processor 101 access to the memory 102.
In other optional embodiments, the B/S webpage with the data template construction function can be constructed through a B/S webpage access mode, and when the B/S webpage is accessed, the construction of the data template and the subsequent data entry process can be completed on the B/S webpage.
The method embodiments provided by the embodiments of the present disclosure may be executed in a computer terminal, a server or a similar computing device, that is, the computer device may include a computer terminal, a server or a similar computing device. The internal structure of the computer device may include, but is not limited to: a processor, a network interface, and a memory. The processor, the network interface and the memory in the computer device may be connected by a bus or other means.
The processor 101 (or CPU) is a computing core and a control core of the computer device. The network interface may optionally include a standard wired interface, a wireless interface (e.g., WI-FI, mobile communication interface, etc.). The Memory 102(Memory) is a Memory device in the computer device for storing programs and data. It is understood that the memory 102 may be a high-speed RAM storage device, or may be a non-volatile storage device (non-volatile memory), such as at least one magnetic disk storage device; optionally, at least one memory device located remotely from the processor 101. The memory 102 provides storage space that stores an operating system of the electronic device, which may include, but is not limited to: a Windows system (an operating system), Linux (an operating system), Android (Android, a mobile operating system) system, IOS (a mobile operating system) system, and the like, which are not limited by the present disclosure; also, one or more instructions, which may be one or more computer programs (including program code), are stored in the memory space and are adapted to be loaded and executed by the processor 101. In the embodiment of the present specification, the processor 101 loads and executes one or more instructions stored in the memory 102 to implement the method for constructing a clinical electronic case report table according to the above method embodiment.
The disclosed embodiments also provide a computer readable storage medium having at least one instruction or at least one program stored thereon, which when loaded by the processor 101, performs the method for constructing a clinical electronic case report form as described above. The computer-readable storage medium carries one or more programs which, when executed, implement the method according to an embodiment of the disclosure.
According to an embodiment of the present disclosure, the computer-readable storage medium may be a non-volatile computer-readable storage medium. Examples may include, but are not limited to: a portable computer diskette, a hard disk, a Random Access Memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the present disclosure, a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.
In the description of the present disclosure, it is to be understood that the orientation or positional relationship indicated by the directional terms such as "front, rear, upper, lower, left, right", "lateral, vertical, horizontal" and "top, bottom", etc., are generally based on the orientation or positional relationship shown in the drawings, and are used for convenience in describing and simplifying the present disclosure, and in the absence of a contrary explanation, these directional terms are not intended to indicate and imply that the device or element being referred to must have a specific orientation or be constructed and operated in a specific orientation, and therefore, should not be considered as limiting the scope of the present disclosure.
Various other modifications and changes may be made by those skilled in the art based on the above-described technical solutions and concepts, and all such modifications and changes should fall within the scope of the claims of the present disclosure.
Claims (9)
1. A method for constructing a clinical electronic case report form, which is characterized by constructing a data template related to the clinical electronic case report form, and comprises the following steps:
and (3) field information construction: constructing corresponding field information according to the test items;
sub-table predefining: predefining a sub-table based on the field information, defining the structure of the content of the sub-table, and associating the fields defined in the field information;
sub-table information definition: defining the structure of the sub-table log line form as a line number fixed structure or a line number unfixed structure; single page form creation: creating a form of a single page and attributing defined fields in the field information to the single page
Establishing a dependency relationship between the page form and/or the defined sub-table and the single page form;
and (3) visiting information construction: generating visit information based on the visit data, and associating the visit information with the single-page form to obtain the data template;
data entry and checking: and inputting and checking the test data of the subject through the data template to generate an electronic case report table of the subject.
2. The clinical electronic case report form constructing method according to claim 1, wherein in the field information constructing step, the field information includes a field name, a field label, and a variable type;
the field name is a unique identifier of the field information, and comprises one or more characters of letters, numbers and underlines;
the field label is a problem description of field information data acquisition or a help text of the field information;
the variable type is one or more of an option type variable, a text type variable, a numerical type variable, a date type variable, a time type variable, a radio box, a drop-down box and a dynamic search box.
3. The clinical electronic case report form constructing method according to claim 2, wherein the number of the field information is at least two groups, and when the content of the referenced field information is changed after the content of one group of the field information references the content of the other group of the field information, the content referencing the field information always shows the latest content of the referenced field information.
4. The clinical electronic case report form building method according to claim 1, wherein in the single-page form creating step, the single-page form comprises a single-page name, a single-page label, and a single-page type;
the single page name is a unique identifier of the single page form, which comprises one and/or more characters of letters, numbers and underlines;
the single-page label is a general description of the single-page form;
the single-page type represents that the single-page form is of a transverse structure, a longitudinal structure or a composite structure, wherein the single-page form of the transverse structure contains fields defined in the field information;
the single-page form with the longitudinal structure comprises the sub-tables defined in the sub-table information, and the dependency relationship between the defined sub-tables and the single-page form is established;
the single page form of the composite structure comprises the fields defined in the field information and the sub-tables defined in the sub-table information, and establishes the dependency relationship between the defined sub-tables and the single page form.
5. The clinical electronic case report form constructing method according to claim 1, wherein in the visiting information constructing step, the visiting information includes a visiting name, a visiting label and a visiting type;
the access name is a unique identifier of the access information and comprises one and/or a plurality of characters of letters, numbers and underlines;
the visit label is a general description of the visit information; the visit type is a fixed visit or an unplanned visit.
6. The method for constructing a clinical electronic case report form according to claim 1, wherein the data entry and check step specifically comprises:
s01, inputting and storing test data in the single-page form, performing logic check on the input data, and entering a step S02 if the logic check is passed, otherwise, giving an alarm and interrupting the step;
s02, submitting the input data, and logically checking the submitted data, if the logical check is passed, entering the 'checking in' state of the step S03, otherwise, initiating a question to the target field;
s03, in the 'checking' state, the data in checking is logically checked, the data passing the logical checking can be checked and confirmed, the data failing the logical checking is questioned, when the data confirmed by checking is modified to fail to pass the logical checking, the confirmation state of the data is released and recovered to the unconfirmed state and the questioning is initiated, and the step S04 is executed after all the data are checked and confirmed;
s04, locking the recording state of the data;
s05, freezing the data to enable the data to enter an unmodified state;
and S06, signing and confirming the input data, and completing the construction of the electronic case report table of the patient.
7. A clinical electronic case report form building system, comprising:
the field information construction module is used for constructing corresponding field information according to the test items;
a sub-table predefining module for performing sub-table predefining based on the field information, defining a structure of sub-table contents, and associating fields defined in the field information;
the sub-table information definition module is used for defining the structure of the sub-table log line form as a line number fixed structure or a line number unfixed structure;
a single page form creation module for creating a single page form and attributing defined fields in the field information
Establishing a dependency relationship between the sub-tables and the single-page form;
the visit information construction module is used for generating visit information based on visit data, associating the visit information with the single-page form and obtaining the data template;
and the data entry and check module is used for entering and checking the test data of the subject through the data template to generate an electronic case report table of the subject.
8. A computer device comprising a processor and a memory in signal communication, wherein the memory has stored therein at least one instruction or at least one program, which when loaded by the processor, performs the method of clinical electronic case report form construction according to any of claims 1-6.
9. A computer readable storage medium having at least one instruction or at least one program stored thereon, wherein the at least one instruction or the at least one program when loaded by a processor performs the method of clinical electronic case report form construction according to any of claims 1-6.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211068702.4A CN115132312A (en) | 2022-09-02 | 2022-09-02 | Method and system for constructing clinical electronic case report table and electronic equipment |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211068702.4A CN115132312A (en) | 2022-09-02 | 2022-09-02 | Method and system for constructing clinical electronic case report table and electronic equipment |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN115132312A true CN115132312A (en) | 2022-09-30 |
Family
ID=83388047
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202211068702.4A Pending CN115132312A (en) | 2022-09-02 | 2022-09-02 | Method and system for constructing clinical electronic case report table and electronic equipment |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN115132312A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115935938A (en) * | 2022-12-29 | 2023-04-07 | 北京国联政信科技有限公司 | Automatic generation method and device for counter report |
| CN116230150A (en) * | 2022-12-27 | 2023-06-06 | 北京百度网讯科技有限公司 | Information processing method, apparatus, device and storage medium |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110213742A1 (en) * | 2010-02-26 | 2011-09-01 | Lemmond Tracy D | Information extraction system |
| CN114300084A (en) * | 2021-12-31 | 2022-04-08 | 科临达康医药生物科技(北京)有限公司 | Method, device and equipment for automatically generating clinical test case report table |
-
2022
- 2022-09-02 CN CN202211068702.4A patent/CN115132312A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110213742A1 (en) * | 2010-02-26 | 2011-09-01 | Lemmond Tracy D | Information extraction system |
| CN114300084A (en) * | 2021-12-31 | 2022-04-08 | 科临达康医药生物科技(北京)有限公司 | Method, device and equipment for automatically generating clinical test case report table |
Non-Patent Citations (1)
| Title |
|---|
| 赵佳等: "我院药物临床试验电子数据采集系统的建立及应用", 《中国药房》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116230150A (en) * | 2022-12-27 | 2023-06-06 | 北京百度网讯科技有限公司 | Information processing method, apparatus, device and storage medium |
| CN115935938A (en) * | 2022-12-29 | 2023-04-07 | 北京国联政信科技有限公司 | Automatic generation method and device for counter report |
| CN115935938B (en) * | 2022-12-29 | 2024-04-02 | 北京国联政信科技有限公司 | Automatic generation method and device for case report |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN115132312A (en) | Method and system for constructing clinical electronic case report table and electronic equipment | |
| US7467113B2 (en) | License verification system and method | |
| US5504890A (en) | System for data sharing among independently-operating information-gathering entities with individualized conflict resolution rules | |
| US10970673B2 (en) | Bill of material synchronization | |
| EP2804061B1 (en) | Method for monitoring a process and/or production plant | |
| CN108564207A (en) | Architectural engineering intelligence Authorize to Bid based on BIM manages system | |
| JPH0778810B2 (en) | Manufacturing process reliability analysis system | |
| DE112013006511T5 (en) | Program and Electronic Manual Display | |
| US10891294B1 (en) | Automatically migrating computer content | |
| CN110851861B (en) | Method for assisting ATC vehicle-mounted safety data verification and automatic generation of verification report | |
| CN112561095A (en) | State monitoring and asset management linkage control method and device | |
| US11102311B2 (en) | Registration during downtime | |
| CN115983232A (en) | Form system based on view and data integrated design | |
| CN108287844A (en) | A kind of public transport data managing method and system and navigation equipment | |
| de Souza et al. | DM4VGI: A template with dynamic metadata for documenting and validating the quality of Volunteered Geographic Information. | |
| CN113177396B (en) | Report generation method and device, computer equipment and storage medium | |
| CA3078118A1 (en) | Stem enhanced question builder | |
| CN112016269A (en) | Policy data marking method and device | |
| CN112381509A (en) | Management system for major special topic of national science and technology for creating major new drug | |
| JP2001265580A (en) | Review supporting system and review supporting method used for it | |
| CN111506315A (en) | Code deployment method for flexible digital control and digital control platform | |
| JP6081305B2 (en) | Field work support system and method | |
| CN103514144A (en) | Apparatus for preparing operating manual list | |
| CN110580145A (en) | Method for realizing batch price adjustment of medicines and having available document to be checked by B/S architecture-based pharmacy system | |
| US20230064846A1 (en) | Failure knowledge structure system and failure knowledge structure method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20220930 |