CN116701305B - Clinical trial electronic file management method, system, terminal and storage medium - Google Patents

Clinical trial electronic file management method, system, terminal and storage medium Download PDF

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CN116701305B
CN116701305B CN202310977189.9A CN202310977189A CN116701305B CN 116701305 B CN116701305 B CN 116701305B CN 202310977189 A CN202310977189 A CN 202310977189A CN 116701305 B CN116701305 B CN 116701305B
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electronic
files
electronic files
records
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CN116701305A (en
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周志欢
周佳
丁锐
贾建国
滑继来
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Beijing Excellent Future International Pharmaceutical Technology Development Co ltd
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    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F16/00Information retrieval; Database structures therefor; File system structures therefor
    • G06F16/10File systems; File servers
    • G06F16/11File system administration, e.g. details of archiving or snapshots
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F16/00Information retrieval; Database structures therefor; File system structures therefor
    • G06F16/10File systems; File servers
    • G06F16/13File access structures, e.g. distributed indices
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F16/00Information retrieval; Database structures therefor; File system structures therefor
    • G06F16/10File systems; File servers
    • G06F16/16File or folder operations, e.g. details of user interfaces specifically adapted to file systems
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

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Abstract

The application relates to a method, a system, a terminal and a storage medium for managing clinical test electronic files, which relate to the technical field of clinical tests, wherein the method comprises the steps of obtaining test item types; a folder directory template is called according to the type of the test item, and a folder directory is created; creating service nodes according to the test item types; according to the test item type, invoking an SOP file, wherein the SOP file comprises target files required by each service node and a storage path of each target file; and determining the storage position of the electronic file in the file cabinet according to the file name of the uploaded electronic file, the file name of the target file and the storage path of the target file. The application has the characteristic of being convenient for managing the electronic files.

Description

Clinical trial electronic file management method, system, terminal and storage medium
Technical Field
The application relates to the technical field of clinical trials, in particular to a method, a system, a terminal and a storage medium for managing electronic files of clinical trials.
Background
Clinical trials refer to any systematic study of drugs in humans (patients or healthy volunteers) to confirm or reveal the effects, adverse reactions and/or absorption, distribution metabolism and excretion of the test drug with the aim of determining the efficacy and safety of the test drug.
It will be appreciated that during the course of a clinical trial program, a plurality of electronic files are generated at each service node. Wherein the individual electronic file also has multiple versions. In addition, the service nodes are more, so that the problems of file deletion and the like are easy to cause, and the searching, checking and management are not facilitated.
Disclosure of Invention
The application aims to provide a clinical test electronic file management method which has the characteristic of being convenient for managing electronic files.
The first object of the present application is achieved by the following technical solutions:
a method of clinical trial electronic file management comprising:
acquiring a test item type;
according to the test item type, a folder directory template is called, and a folder directory is created;
creating a service node according to the test item type;
according to the test item type, invoking an SOP file, wherein the SOP file comprises target files required by each service node and a storage path of each target file;
and determining the storage position of the electronic file in the file cabinet according to the file name of the uploaded electronic file, the file name of the target file and the storage path of the target file.
By adopting the technical scheme, when the type of the test item is determined, the folder directory template and the SOP file can be determined according to the type of the test item. Then, a folder directory identical to the folder directory template can be created according to the folder directory template. The SOP file records the target file required by each service node and the storage path of each target file, so that the service nodes, the target files and the folder directory are connected, and the electronic files are convenient to manage.
Optionally, the method further comprises:
when an operator submits a service node, acquiring a target file required by the service node from the SOP file;
acquiring an electronic file in a folder associated with the service node;
and submitting the service node when determining that the electronic files in the folder associated with the service node correspond to the target files required by the service node one by one.
Optionally, the method further comprises:
acquiring a history operation record, wherein the history operation record comprises a modification operation history and a browsing operation history, the modification operation history comprises a plurality of modification records, the browsing operation history comprises a plurality of browsing records, each modification record comprises visitor information and modified electronic files, and modification time, and each browsing record comprises visitor information and browsed electronic files, and browsing time;
determining a first set of associated files from the modified electronic files in each modification record and the browsed electronic files in all browsed records based on a first analysis rule;
determining a second set of associated files based on the second analysis rules from the visitor information in all browsed records, the browsed electronic files and the visitor information in all modified records;
The first association file set and the second association file set are used for reflecting association relations among all electronic files;
acquiring an electronic file which is being modified by a current visitor;
based on the association relation between all the electronic files, determining a recommended directory according to the electronic files being modified, wherein the recommended directory comprises the electronic files with the association relation with the electronic files being modified.
By adopting the technical scheme, the association relation among all the electronic files can be obtained through analysis, and when a visitor modifies a certain electronic file, the corresponding electronic file can be pushed to the visitor according to the association relation, so that the visitor forgets to modify the certain electronic file due to excessive electronic files when modifying the electronic file.
Optionally, the determining, based on the first analysis rule, the first association file set according to the modified electronic file in each modification record and the browsed electronic files in all browsed records includes:
selecting a modification record, and associating the related electronic file group with a file set to be determined;
when the ratio of the occurrence times of the electronic files in the undetermined associated file set in all the browsing records to the occurrence times of the first appointed electronic file in all the browsing records reaches a preset value, the electronic files in the undetermined associated file set are formed into a first associated file subset, and the first appointed electronic file is the first modified electronic file in one modification record;
All the first associated file subsets constitute a first associated file set.
Optionally, the determining, based on the first analysis rule, the first association file set according to the modified electronic file in each modification record and the browsed electronic files in all browsed records includes:
if the ratio of the number of times of occurrence of the electronic files in the undetermined associated file set to the number of times of occurrence of the first appointed electronic file in all the browsing records is lower than a preset value, the undetermined associated file set is adjusted, the electronic files with the latest modification time are removed from the undetermined associated file set, whether the ratio of the number of times of occurrence of the electronic files in the undetermined associated file set to the number of times of occurrence of the first appointed electronic file in all the browsing records reaches the preset value is judged, if not, the undetermined associated file set is continuously adjusted until the ratio of the number of times of occurrence of the electronic files in the undetermined associated file set to the number of times of occurrence of the first appointed electronic file in all the browsing records reaches the preset value.
Optionally, the determining, based on the second analysis rule, the second association file set according to the visitor information in all the browsed records, the browsed electronic file, and the visitor information in all the modified records includes:
Selecting one electronic file as a second designated electronic file;
recording a plurality of electronic files with the largest repeated occurrence times in the plurality of browsing records as a prediction associated file set, wherein a second designated electronic file exists in the plurality of electronic files;
determining the sequence of visitors with the number of modified records from high to low, and selecting a preset number of visitors according to the sequence as reference visitors;
when the electronic files related to the predicted associated file set are simultaneously appeared in any modification record of the reference visitor, determining the predicted associated file set as a second associated file subset;
all the second associated file subsets constitute a second associated file set.
The application also aims to provide a clinical test electronic file management system which has the characteristic of being convenient for managing electronic files.
The second object of the present application is achieved by the following technical solutions:
a clinical trial electronic document management system includes,
the first acquisition module is used for acquiring the types of test items;
the invoking module is used for invoking a folder directory template according to the test item type and is used for invoking an SOP file according to the test item type, wherein the SOP file comprises target files required by each service node and a storage path of each target file;
The first creating module is used for creating a folder directory according to the folder directory template;
the second creation module is used for creating service nodes according to the test item types; the method comprises the steps of,
and the path determining module is used for determining the storage position of the electronic file in the file cabinet according to the file name of the uploaded electronic file, the file name of the target file and the storage path of the target file.
Optionally, the method further comprises:
a second obtaining module, configured to obtain a history operation record, where the history operation record includes a modification operation history and a browsing operation history, the modification operation history includes a plurality of modification records, the browsing operation history includes a plurality of browsing records, each modification record includes visitor information and a modified electronic file, and a modification time, and each browsing record includes visitor information and a browsed electronic file, and a browsing time;
the first determining module is used for determining a first associated file set according to the modified electronic files in each modification record and the browsed electronic files in all browsed records based on a first analysis rule;
the second determining module is used for determining a second associated file set according to visitor information in all browsing records, browsed electronic files and visitor information in all modification records based on a second analysis rule;
The first association file set and the second association file set are used for reflecting association relations among all electronic files;
the third acquisition module is used for acquiring the electronic file which is being modified by the current visitor;
and the third determining module is used for determining a recommended directory according to the electronic files being modified based on the association relation among all the electronic files, wherein the recommended directory comprises the electronic files with the association relation with the electronic files being modified.
The application aims at providing an intelligent terminal which has the characteristic of being convenient for managing electronic files.
The third object of the present application is achieved by the following technical solutions:
an intelligent terminal comprises a memory and a processor, wherein the memory stores a computer program which can be loaded by the processor and execute the clinical trial electronic file management method.
The fourth object of the present application is to provide a computer storage medium capable of storing a corresponding program, which has the characteristics of being convenient to realize and manage electronic files.
The fourth object of the present application is achieved by the following technical solutions:
a computer readable storage medium storing a computer program capable of being loaded by a processor and executing any one of the above-described clinical trial electronic file management methods.
In summary, the present application includes at least one of the following beneficial technical effects:
in the present application, when determining the test item type, the folder directory template and the SOP file can be determined according to the test item type. Then, a folder directory identical to the folder directory template can be created according to the folder directory template. The SOP file records the target file required by each service node and the storage path of each target file, so that the service nodes, the target files and the folder directory are connected, and the electronic files are convenient to manage.
Drawings
FIG. 1 is a partial flow chart of a method for managing clinical trial electronic files according to one embodiment of the application.
FIG. 2 is a partial flow chart of a method for managing clinical trial electronic files according to one embodiment of the application.
FIG. 3 is a partial system diagram of a clinical trial electronic file management system according to one embodiment of the application.
FIG. 4 is a partial system diagram of a clinical trial electronic file management system according to one embodiment of the application.
Fig. 5 is a schematic structural diagram of an intelligent terminal according to an embodiment of the present application.
In the figure, 21, a first acquisition module; 22. a calling module; 23. a first creation module; 24. a second creation module; 25. a path determination module; 26. a second acquisition module; 27. a first determination module; 28. a second determination module; 29. a third acquisition module; 30. a third determination module; 301. a CPU; 302. a ROM; 303. a RAM; 304. a bus; 305. an I/O interface; 306. an input section; 307. an output section; 308. a storage section; 309. a communication section; 310. a driver; 311. removable media.
Detailed Description
The present application will be described in further detail with reference to the accompanying drawings.
The present embodiment is only for explanation of the present application and is not to be construed as limiting the present application, and modifications to the present embodiment, which may not creatively contribute to the present application as required by those skilled in the art after reading the present specification, are all protected by patent laws within the scope of claims of the present application.
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the technical solutions of the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments of the present application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
In addition, the term "and/or" herein is merely an association relationship describing an association object, and means that three relationships may exist, for example, a and/or B may mean: a exists alone, A and B exist together, and B exists alone. In this context, unless otherwise specified, the term "/" generally indicates that the associated object is an "or" relationship.
The embodiment of the application provides a clinical test electronic file management method which is applied to the implementation process of clinical test projects, and can store a large number of electronic files generated in the clinical test process in a specific mode so as to manage the generated electronic files according to service nodes and facilitate searching.
Embodiments of the application are described in further detail below with reference to the drawings.
The embodiment of the application provides a main flow description of a clinical test electronic file management method.
As shown in fig. 1:
step S101: and obtaining the type of the test item.
The test item types comprise various item types such as clinical pharmacology research, exploratory clinical test, deterministic clinical test and the like. The type of test item is determined empirically by the operator.
Step S102: and calling a folder directory template according to the test item type, and creating a folder directory.
It will be appreciated that each trial item type corresponds to a folder directory template. Although the test environment, test requirements, test scope, etc. are different from one test item to another, when the test item types of the plurality of test items are the same, the folder catalog templates adopted by the different test items are the same. Therefore, when an operator starts to perform a certain test item, the operator can judge the test item type of the test item according to experience, so that the corresponding folder directory template is called from a plurality of folder directory templates according to the test item type.
The folder directory template can reflect the form in which the electronic file is stored. When a folder directory template is called, a folder directory identical to the folder directory template can be created according to the folder directory template.
Step S103: and creating a service node according to the test item type.
Similarly, each test item type corresponds to a business process, and the business process comprises a plurality of business nodes. When the test item types of different test item names are the same, the created service nodes are the same.
Of course, in practical application, after determining the types of test items, namely creating the folder directory and the service nodes, although the subordinate relations of the folder directory are determined and cannot be adjusted, operators can add folders of other levels in the folder directory according to practical situations. For example, if a folder directory created according to the type of test item includes a tertiary folder, the operator cannot change the tertiary folder, but the operator may add a fourth-level folder to the tertiary folder, or may add a fifth-level folder to the fourth-level folder. Of course, the service node can also be increased and adjusted according to the requirement of the operator.
Step S104: and calling an SOP file according to the test item type.
It will also be appreciated that upon receipt of a test item, the operator, in addition to creating a folder directory and business nodes based on the test item type, has an SOP file as opposed to the test item type. The SOP files include target files required for each service node, and a storage path for each target file. It follows that by means of SOP files, connections can be made between service nodes, electronic files and folder directories.
Step S105: and determining the storage position of the electronic file in the file cabinet according to the file name of the uploaded electronic file, the file name of the target file and the storage path of the target file.
Since many steps are required during the whole test item, each step is performed within a planned period of time, and electronic files may be generated, these generated electronic files also need to be uploaded to the system sequentially. In order to facilitate the storage of the uploaded electronic files, when one electronic file is uploaded into the system, the file name of the electronic file is firstly obtained, and whether the file name is consistent with the file name of the target file is judged. If the file name is consistent with the file name of the target file, the electronic file is the target file required by a certain service node. At this time, the storage path of the target file is determined from the SOP file, and the electronic file is stored according to the storage path.
Otherwise, if the file name is inconsistent with the file name of the target file, it indicates that the electronic file is not the target file required by a certain service node specified in the SOP file. At this time, the operator can set the storage path of the electronic file by himself.
Of course, since some service nodes may last for a period of time, such as a conference, the content of each discussion may not be the same, and thus a conference summary may be generated after each discussion is completed. The content recorded for each meeting summary is different. In order to facilitate the process of sorting each test item, each electronic file generated at any one service node or an electronic file obtained by modifying a certain electronic file should be stored in a corresponding folder.
In the service system, when executing a test item, an operator needs to submit the service node after completing each service node and uploading the required electronic file, so as to manage the electronic files generated by different service nodes in the implementation process of the test item.
When an operator submits a certain service node, the service system can acquire a target file required by the service node from the SOP file. And simultaneously acquiring the electronic files in the folders associated with the service node. And comparing the electronic files in the folders associated with the service nodes with the target files required by the service nodes one by one, and if the electronic files in the folders associated with the service nodes can be in one-to-one correspondence with the target files required by the service nodes, indicating that the target files required by the service nodes are uploaded, wherein the service nodes can submit. Otherwise, if the electronic file in the folder associated with the service node does not correspond to the target file required by the service node one by one, the target file required by the service node is not completely uploaded. At this point, the service system does not allow the operator to submit the service node.
The above procedure is only for one test item. After a plurality of test items are completed, operators can check and manage the electronic files in other modes besides checking the corresponding electronic files through the test items.
Referring to fig. 2, it can be understood that in the service system, different operators have different rights, for example, operators can only browse all electronic files, and operators can browse all electronic files and can also modify all electronic files. In general, some electronic files have relevance, but the number of electronic files is large, and when an operator modifies a certain electronic file, the operator may easily forget to modify the electronic file with strong relevance. To this end, in order to facilitate management of electronic files, the clinical trial electronic file management method of the present application further includes:
step S201: and acquiring a historical operation record.
The history operation record records all operation records, and the operation modes mainly comprise modification operation and browsing operation, so the history operation record comprises modification operation history and browsing operation history. Wherein the modification operation history includes a plurality of modification records. Each modification record includes visitor information and a modified electronic file, as well as a modification time. The browsing operation history also includes a plurality of browsing records. Each of the browsing records includes the visitor and the electronic file browsed, as well as the browsing time. It should be noted that, in each modification record or each browsing record, when one visitor performs one operation, one or more files may be subjected to a browsing operation or a modification operation. All the browsing records and the modification records can be obtained by sorting the history operation records.
It can be appreciated that, when modifying the file, a general operator sequentially modifies the electronic files with relevance, so that a part of the electronic files with relevance can be accurately determined according to the modification record. Further, when an operator browses electronic files, there may be a certain correlation between electronic files browsed at the same time. Therefore, the first associated file set and the second associated file set can be determined respectively according to the two cases.
Step S202: based on the first analysis rule, a first set of associated files is determined from the modified electronic files in each modification record and the browsed electronic files in all browsed records.
It is appreciated that the first set of associated files includes a plurality of first subsets of associated files. The first subset of associated files includes a set of electronic files having an association. The following description will take an example of obtaining a first associated file subset.
Firstly, selecting a modification record, and forming a set of undetermined associated files by all modified electronic files in the modification record. I.e. after selecting a modification record, defaulting to all modified electronic files in the modification record to have relevance.
However, in practice, when the operator modifies the electronic files, not all the modified electronic files have a certain relevance, so that it is necessary to determine the relevance between the electronic files in the set of files to be associated again.
Specifically, the number of occurrences of the electronic file of the set of files to be associated in all the browsing records is first determined. Then, the number of times the first specified electronic file appears in all the browsing records is determined. The first appointed electronic file is the electronic file modified first in a modification record. Further, the ratio of the number of times of occurrence of the electronic file of the undetermined associated file set in all the browsing records to the number of times of occurrence of the first appointed electronic file in all the browsing records is calculated, and the size relation between the ratio and the preset value is judged.
It should be noted that, if there is a relationship between electronic files in the set of files to be associated, when an operator browses an electronic file, the operator browses a file associated with the electronic file. I.e. the electronic files of the set of pending associated files will appear in the browsing record. Taking the first specified electronic file as an example, in fact, electronic files in the set of files to be associated do not necessarily appear in all the browsing records related to the first specified electronic file, so it is necessary to determine the number of times the first specified electronic file appears in all the browsing records. Of course, in other embodiments, the first specified electronic file may be any electronic file in the set of pending associated files.
When the ratio of the number of times of occurrence of the electronic files in the set of the undetermined associated files in all the browsing records to the number of times of occurrence of the first designated electronic file in all the browsing records reaches a preset value, that is, the number of times of occurrence of the electronic files in the set of the undetermined associated files in all the browsing records is more, the electronic files in the set of the undetermined associated files can be considered to have relevance, and the electronic files in the set of the undetermined associated files form a first associated file subset.
Otherwise, if the ratio of the number of occurrences of the electronic files in the set of files to be associated in all the browsing records to the number of occurrences of the first designated electronic file in all the browsing records is lower than a preset value, it is indicated that the occurrence of the electronic files in the set of files to be associated may be accidental in all the browsing records, and all the electronic files in the set of files to be associated do not have an association, and the electronic files having the association need to be determined by adjusting the set of files to be associated.
Specifically, in the application, the electronic file with the latest modification time is removed from the set of files to be associated, and then whether the ratio of the number of times the electronic file in the set of files to be associated appears in all browsing records to the number of times the first designated electronic file appears in all browsing records reaches a preset value is judged according to the steps, if not, continuing to adjust the undetermined associated file set until the ratio of the number of times of the occurrence of the electronic file in the undetermined associated file set in all the browsing records to the number of times of the occurrence of the first designated electronic file in all the browsing records reaches a preset value.
Preferably, the preset value may be 10%.
After determining one first associated file subset, all first associated file subsets may be determined according to the above steps to determine the first associated file set.
Step S203: based on the second analysis rules, a second set of associated files is determined from the visitor information in all browsed records, the browsed electronic file, and the visitor information in all modified records.
Likewise, the second set of associated files includes a plurality of second subsets of associated files. The second subset of associated files includes a set of electronic files having an association. The following description will take as an example the obtaining of a second subset of associated files.
First, an electronic file is selected as a second designated electronic file. At this time, the selection range of the second designated electronic file is all the electronic files. And then, a plurality of electronic files with the largest repeated occurrence number in the plurality of browsing records are recorded as a prediction associated file set, and a second designated electronic file exists in the plurality of electronic files.
It can be understood that when browsing electronic files, different operators browse different electronic files according to their own demands, so when a plurality of electronic files repeatedly appear in browsing records of different operators, it is indicated that there is a high possibility of correlation between the electronic files. In order to confirm the relevance between these electronic files again, it is also necessary to select a reference visitor whose modification record is used as a reference.
Since the operator is more familiar with all electronic files when the operator makes a larger number of modifications to all electronic files, the operator is more likely to have a correlation between the electronic files modified by the operator. Thus, such an operator is suitable as a reference visitor. Specifically, the visitor order in which the number of modification records is from high to low is determined. In consideration of the fact that an operator's modification record cannot cover all electronic files, a predetermined number of visitors are selected in this order as reference visitors in the present application. Preferably, the preset number may be three.
Then, when the electronic files related to the predicted associated file set are simultaneously appeared in any modification record of the reference visitor, the condition that operators with rich experience of modifying the electronic files have simultaneous modification on the electronic files is indicated, and the relevance among the electronic files can be indicated. At this time, the predicted associated file set is determined as the second associated file subset.
After determining one second associated file subset, all second associated file subsets may be determined according to the above steps to determine a second associated file set.
Step S204: an electronic file that is currently being modified by the visitor is obtained.
Step S205: based on the association relationship between all the electronic files, a recommended directory is determined according to the electronic file being modified.
Wherein the recommended directory includes electronic files having an association with the electronic file being modified.
When the first association file set and the second association file set are determined, the association relationship among all the electronic files is determined. When an operator modifies a certain electronic file, the electronic file with relevance to the electronic file can be recommended to the operator when the operator acquires the modified electronic file, so that the operator can uniformly modify the electronic file.
Fig. 3 and 4 are diagrams of a clinical trial electronic file management system according to an embodiment of the present application.
The clinical trial electronic file management system as shown in fig. 3 and 4 comprises a first acquisition module 21, a retrieval module 22, a first creation module 23, a second creation module 24, a path determination module 25, a second acquisition module 26, a first determination module 27, a second determination module 28, a third acquisition module 29 and a third determination module 30, wherein:
a first acquisition module 21, configured to acquire a test item type.
The retrieving module 22 is configured to retrieve a folder directory template according to the test item type, and is configured to retrieve an SOP file according to the test item type, where the SOP file includes a target file required by each service node, and a storage path of each target file.
The first creating module 23 is configured to create a folder directory according to the folder directory template.
A second creation module 24 for creating a service node according to the trial item type.
The path determining module 25 is configured to determine a storage location of the electronic file in the file cabinet according to the file name of the uploaded electronic file, the file name of the target file, and the storage path of the target file.
A second obtaining module 26, configured to obtain a history operation record, where the history operation record includes a modification operation history and a browsing operation history, where the modification operation history includes a plurality of modification records, and the browsing operation history includes a plurality of browsing records, each modification record includes visitor information and a modified electronic file, and a modification time, and each browsing record includes visitor information and a browsed electronic file, and a browsing time.
A first determining module 27 is configured to determine a first set of associated files from the modified electronic files in each modification record and the browsed electronic files in all browsed records based on a first analysis rule.
A second determining module 28 is configured to determine a second set of associated files based on the second analysis rules based on the visitor information in all browsed records, the browsed electronic files, and the visitor information in all modified records.
A third obtaining module 29, configured to obtain an electronic file that is being modified by the current visitor.
The third determining module 30 is configured to determine a recommended directory according to the electronic files being modified, based on the association relationships between all the electronic files, where the recommended directory includes electronic files having association relationships with the electronic files being modified.
Fig. 5 shows a schematic structural diagram of a smart terminal suitable for implementing an embodiment of the present application.
As shown in fig. 5, the smart terminal includes a Central Processing Unit (CPU) 301 that can perform various appropriate actions and processes according to a program stored in a Read Only Memory (ROM) 302 or a program loaded from a storage section into a Random Access Memory (RAM) 303. In the RAM 303, various programs and data required for the system operation are also stored. The CPU 301, ROM 302, and RAM 303 are connected to each other through a bus 304. An input/output (I/O) interface 305 is also connected to bus 304.
The following components are connected to the I/O interface 305: an input section 306 including a keyboard, a mouse, and the like; an output portion 307 including a Cathode Ray Tube (CRT), a Liquid Crystal Display (LCD), and the like, a speaker, and the like; a storage section 308 including a hard disk or the like; and a communication section 309 including a network interface card such as a LAN card, a modem, or the like. The communication section 309 performs communication processing via a network such as the internet. The drive 310 is also connected to the I/O interface 305 as needed. A removable medium 311 such as a magnetic disk, an optical disk, a magneto-optical disk, a semiconductor memory, or the like is installed on the drive 310 as needed, so that a computer program read out therefrom is installed into the storage section 308 as needed.
In particular, the process described above with reference to flowchart fig. 1 may be implemented as a computer software program according to an embodiment of the application. For example, embodiments of the application include a computer program product comprising a computer program embodied on a machine-readable medium, the computer program comprising program code for performing the method shown in the flowcharts. In such an embodiment, the computer program may be downloaded and installed from a network via the communication portion 309, and/or installed from the removable medium 311. The above-described functions defined in the system of the present application are performed when the computer program is executed by a Central Processing Unit (CPU) 301.
The computer readable medium shown in the present application may be a computer readable signal medium or a computer readable storage medium, or any combination of the two. The computer readable storage medium can be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or a combination of any of the foregoing. More specific examples of the computer-readable storage medium may include, but are not limited to: an electrical connection having one or more wires, 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), an optical fiber, 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 context of this document, 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 present application, however, the computer-readable signal medium may include a data signal propagated in baseband or as part of a carrier wave, with the computer-readable program code embodied therein. Such a propagated data signal may take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination of the foregoing. A computer readable signal medium may also be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device. Program code embodied on a computer readable medium may be transmitted using any appropriate medium, including but not limited to: wireless, wire, fiber optic cable, RF, etc., or any suitable combination of the foregoing.
The flowcharts and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods and computer program products according to various embodiments of the present application. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s). It should also be noted that, in some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems which perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.
The units or modules involved in the embodiments of the present application may be implemented in software or in hardware. The described units or modules may also be provided in a processor, for example, as: a processor comprising: the first acquisition module 21, the call module 22, the first creation module 23, the second creation module 24, the path determination module 25, the second acquisition module 26, the first determination module 27, the second determination module 28, the third acquisition module 29, and the third determination module 30. The names of these units or modules do not constitute a limitation of the unit or module itself in some cases, and for example, the first acquisition module 21 may also be described as "a module for acquiring a test item type".
As another aspect, the present application also provides a computer-readable storage medium, which may be included in the intelligent terminal described in the above embodiment; or may exist alone without being assembled into the smart terminal. The computer-readable storage medium stores one or more programs that when executed by one or more processors perform the clinical trial electronic file management method described in the present application.
The above description is only illustrative of the preferred embodiments of the present application and of the principles of the technology employed. It will be appreciated by persons skilled in the art that the scope of the application is not limited to the specific combinations of the features described above, but also covers other embodiments which may be formed by any combination of the features described above or their equivalents without departing from the spirit of the application. Such as the above-mentioned features and the technical features having similar functions (but not limited to) applied for in the present application are replaced with each other.

Claims (7)

1. A method for managing clinical trial electronic files, comprising:
Acquiring a test item type;
according to the test item type, a folder directory template is called, and a folder directory is created;
creating a service node according to the test item type;
according to the test item type, invoking an SOP file, wherein the SOP file comprises target files required by each service node and a storage path of each target file;
storing the electronic file according to the file name of the uploaded electronic file, the file name of the target file and the storage path of the target file;
when an operator submits a service node, acquiring a target file required by the service node from the SOP file;
acquiring an electronic file in a folder associated with the service node;
determining that the electronic files in the folder associated with the service node correspond to the target files required by the service node one by one, and submitting the service node;
acquiring a history operation record, wherein the history operation record comprises a modification operation history and a browsing operation history, the modification operation history comprises a plurality of modification records, the browsing operation history comprises a plurality of browsing records, each modification record comprises visitor information and modified electronic files, and modification time, and each browsing record comprises visitor information and browsed electronic files, and browsing time;
Determining a first set of associated files from the modified electronic files in each modification record and the browsed electronic files in all browsed records based on a first analysis rule;
determining a second set of associated files based on the second analysis rules from the visitor information in all browsed records, the browsed electronic files and the visitor information in all modified records;
the first association file set and the second association file set are used for reflecting association relations among all electronic files;
acquiring an electronic file which is being modified by a current visitor;
determining a recommended directory according to the electronic files being modified based on the association relation among all the electronic files, wherein the recommended directory comprises the electronic files with the association relation with the electronic files being modified;
the storing the electronic file according to the file name of the uploaded electronic file, the file name of the target file and the storage path of the target file comprises the following steps:
acquiring the file name of an electronic file, and judging whether the file name of the electronic file is consistent with the file name of a target file;
if the file name of the electronic file is consistent with the file name of the target file, determining a storage path of the target file from the SOP file, and storing the electronic file according to the storage path;
And if the file name of the electronic file is inconsistent with the file name of the target file, acquiring the input storage path for storage.
2. The method of claim 1, wherein determining the first set of associated files from the modified electronic files in each modification record and the browsed electronic files in all browsed records based on the first analysis rule comprises:
selecting a modification record, and associating the related electronic file group with a file set to be determined;
when the ratio of the occurrence times of the electronic files in the undetermined associated file set in all the browsing records to the occurrence times of the first appointed electronic file in all the browsing records reaches a preset value, the electronic files in the undetermined associated file set are formed into a first associated file subset, and the first appointed electronic file is the first modified electronic file in one modification record;
all the first associated file subsets constitute a first associated file set.
3. The method of claim 2, wherein determining the first set of associated files from the modified electronic files in each modification record and the browsed electronic files in all browsed records based on the first analysis rule comprises:
If the ratio of the number of times of occurrence of the electronic files in the undetermined associated file set to the number of times of occurrence of the first appointed electronic file in all the browsing records is lower than a preset value, the undetermined associated file set is adjusted, the electronic files with the latest modification time are removed from the undetermined associated file set, whether the ratio of the number of times of occurrence of the electronic files in the undetermined associated file set to the number of times of occurrence of the first appointed electronic file in all the browsing records reaches the preset value is judged, if not, the undetermined associated file set is continuously adjusted until the ratio of the number of times of occurrence of the electronic files in the undetermined associated file set to the number of times of occurrence of the first appointed electronic file in all the browsing records reaches the preset value.
4. The method of claim 1, wherein determining the second set of associated files based on the visitor information in all browsed records, the browsed electronic file, and the visitor information in all modified records based on the second analysis rule comprises:
selecting one electronic file as a second designated electronic file;
recording a plurality of electronic files with the largest repeated occurrence times in the plurality of browsing records as a prediction associated file set, wherein a second designated electronic file exists in the plurality of electronic files;
Determining the sequence of visitors with the number of modified records from high to low, and selecting a preset number of visitors according to the sequence as reference visitors;
when the electronic files related to the predicted associated file set are simultaneously appeared in any modification record of the reference visitor, determining the predicted associated file set as a second associated file subset;
all the second associated file subsets constitute a second associated file set.
5. A clinical trial electronic document management system, comprising,
a first acquisition module (21) for acquiring a test item type;
the retrieving module (22) is used for retrieving a folder directory template according to the test item type and retrieving an SOP file according to the test item type, wherein the SOP file comprises target files required by each service node and a storage path of each target file;
a first creation module (23) for creating a folder directory from the folder directory template;
a second creation module (24) for creating a service node from the trial item type; the method comprises the steps of,
the path determining module (25) is used for storing the electronic file according to the file name of the uploaded electronic file, the file name of the target file and the storage path of the target file, and is also used for acquiring the target file required by the service node from the SOP file when an operator submits the service node; acquiring an electronic file in a folder associated with the service node; determining that the electronic files in the folder associated with the service node correspond to the target files required by the service node one by one, and submitting the service node;
A second obtaining module (26) for obtaining a history of operation, the history of operation comprising a history of modification operations and a history of browsing operations, the history of modification operations comprising a plurality of modification records, the history of browsing operations comprising a plurality of browsing records, each modification record comprising visitor information and a modified electronic file, and a modification time, each browsing record comprising visitor information and a browsed electronic file, and a browsing time;
a first determining module (27) for determining a first set of associated files from the modified electronic files in each modification record and the browsed electronic files in all browsed records based on a first analysis rule;
a second determining module (28) for determining a second set of associated files based on the second analysis rules from the visitor information in all browsed records, the browsed electronic files and the visitor information in all modified records;
the first association file set and the second association file set are used for reflecting association relations among all electronic files;
a third obtaining module (29) for obtaining an electronic file being modified by the current visitor;
and a third determining module (30) for determining a recommended directory according to the electronic files being modified based on the association relation among all the electronic files, wherein the recommended directory comprises the electronic files having the association relation with the electronic files being modified.
6. An intelligent terminal comprising a memory and a processor, said memory having stored thereon a computer program capable of being loaded by the processor and executing the method according to any of claims 1 to 4.
7. A computer readable storage medium, characterized in that a computer program is stored which can be loaded by a processor and which performs the method according to any of claims 1 to 4.
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