A method for generating a file path of an eCTD document and a system thereof
Patent Information
- Application Number
- CN202311720975.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-12-14
- Publication Date
- 2026-08-21
AI Technical Summary
[0004]eCTD申报过程中，会涉及到大量文件，这些文件需按照规范进行整理存放，每一个文件的文件路径都有特定的规范和建议，人工整理容易出错，整个流程比较繁琐，需消耗大量时间和人力成本
[0029]本发明的优点在于：使用预先设计的虚拟目录树来使用户上传文件，而虚拟目录树是事先根据地方法律法规设计的，用户只需要按照要求在特定的叶子节点处上传文件即可，能够有效减少用户工作量，提高效率；
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Figure CN122614799A_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of clinical trial technology, and in particular relates to a method and system for generating file paths of eCTD documents. Background Technology
[0002] eCTD (Electronic Common Technical Document) is an internationally recognized document format that can be used to create a well-structured registration application document for submission to a drug registration authority. It was adopted by ICH to address the issue of uniformity in format and content for drug registration applications for human use.
[0003] In the early days, applicants would prepare their documents according to the CTD (Content Delivery Method) format, print them out, and submit them by mail. With the widespread use of computers and the standardization of processes, this traditional paper submission has been replaced by electronic submission.
[0004] The eCTD application process involves a large number of documents, which need to be organized and stored in accordance with the specifications. The file path of each document has specific specifications and suggestions. Manual organization is prone to errors, and the whole process is quite cumbersome, requiring a lot of time and manpower.
[0005] The file path includes both folders and filenames. Typically, applications involve a large number of files, and all files and folders are named by the applicant. Organizing the file path by the applicant themselves consumes significant time and manpower. Furthermore, manually specified filenames by the applicant may result in duplicates and filename conflicts, leading to file loss. In addition, requiring the applicant to name the files themselves necessitates familiarity with official requirements, which is difficult in practice and often results in non-standard or non-compliant file naming. Summary of the Invention
[0006] The purpose of this invention is to address the above-mentioned problems by providing a method for generating the file path of an eCTD document, the method comprising:
[0007] S1. Create a virtual directory tree containing the application number and serial number for the user's application request, allowing the user to upload files to a specific address;
[0008] S2. Obtain a directory tree that maps to the files uploaded by the user;
[0009] S3. Obtain the application number and serial number from the directory tree and create the root path for the release file;
[0010] S4. Starting from the root node of the directory tree, traverse each node downwards and create a corresponding file path for each node under the file root path:
[0011] For each chapter node, the folder name is matched according to the mapping relationship between the chapter tree path and the folder name, and a folder with the corresponding folder name is created under the current file path; the mapping relationship is set in advance by technical personnel.
[0012] Alternatively, create a folder in the current file path whose name is a combination of the attributes of the current chapter;
[0013] For leaf nodes, based on the chapter they are in, the file name is obtained according to the automatic file naming rules under different chapters, and the corresponding file is downloaded from a specific address to the current file path and named with the file name mentioned above.
[0014] S5. After traversing all leaf nodes, generate the final valid release package content.
[0015] In the above-mentioned method for generating the file path of eCTD documents, in step S1, the files uploaded by the user for this application request are uniformly stored in the specific address, which is a file address provided by the system cloud for the current application.
[0016] In step S2, each file uploaded by the user to the specific address corresponds to a leaf node in the directory tree. Each file has a corresponding leaf node and chapter node. However, the chapter node and leaf node may not necessarily have a corresponding file.
[0017] In the above method for generating file paths for eCTD documents, in step S1, each leaf node of the created virtual directory tree has an upload interface for users to upload files.
[0018] Furthermore, each file uploaded by a user is mapped to the corresponding leaf node of the virtual directory tree based on the upload interface used.
[0019] In the above-mentioned method for generating file paths for eCTD documents, this method further includes, in step S1, each chapter node of the virtual directory tree provides a node addition button, and according to the user's operation on the node addition button, a new chapter node or leaf node is added under the corresponding chapter node, and a corresponding upload interface is created for the leaf node added by the user.
[0020] In the above method for generating file paths for eCTD documents, in step S4, for chapter nodes, the folder name is generated and the corresponding folder is created according to one of the two methods mentioned above, based on a preset method.
[0021] Furthermore, for chapter nodes, if there is neither a chapter attribute nor a matching folder name, the folder will not be created.
[0022] Alternatively, based on the title of the current chapter node, filter its characters to generate a new folder name, and create a folder with that folder name in the current file path.
[0023] In the above method for generating file paths for eCTD documents, this method also includes recursively searching for and removing empty folders that have been generated under the file root path after traversing the entire directory tree.
[0024] In the above method for generating file paths for eCTD documents, in step S1, a corresponding virtual directory tree is created based on the application object selected by the user.
[0025] In the above-mentioned method for generating the file path of the eCTD document, in step S4, the chapter attributes include any one or more of the following: country, active ingredient, manufacturer, and formulation name, and the folder name is generated by combining all existing chapter attributes.
[0026] In the above method for generating file paths for eCTD documents, for leaf nodes, when the user selects a custom name and the custom name is not empty, the user-defined name is used as the file name, and the file downloaded from the specific address is named with the user-defined file name.
[0027] When the complete file name is obtained, the current file name is filtered for characters and then checked to see if a file with the same name exists in the current file directory. If it does, an incrementing number is added to the file name to rename it.
[0028] An eCTD system for performing the methods described above.
[0029] The advantages of this invention are: it uses a pre-designed virtual directory tree to allow users to upload files. The virtual directory tree is designed in advance according to local laws and regulations. Users only need to upload files at specific leaf nodes as required, which can effectively reduce the workload of users and improve efficiency.
[0030] The system automatically generates application packages based on the directory tree, and automatically plans file paths for the application packages by having child nodes inherit from parent nodes. It also automatically names each folder and file according to certain rules, eliminating the need for users to spend a lot of time organizing names and paths. This can improve efficiency and effectively reduce the error rate of applications. Attached Figure Description
[0031] Figure 1 This is a flowchart of the method for generating the file path of an eCTD document provided by the present invention;
[0032] Figure 2 This is a diagram illustrating the existence of a file uploaded by a user through a virtual directory tree for a certain application request in the cloud.
[0033] Figure 3 This is a partial screenshot of the virtual directory tree generated during the execution of the file path generation method for eCTD documents provided by this invention;
[0034] Figure 4 This is a partial screenshot of the application release package generated by the file path generation method for eCTD documents provided by this invention. Detailed Implementation
[0035] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments.
[0036] like Figure 1 As shown, this solution proposes a method for generating file paths of eCTD documents and a system for implementing the method. The method includes:
[0037] S1. Create a virtual directory tree containing the application number and sequence number of the current application for the user's application request, allowing the user to upload files to a specific address.
[0038] The system pre-stores at least one virtual directory tree designed by technicians in accordance with official legal regulations. In this embodiment, for example, the system has three virtual directory trees corresponding to China, the United States, and the European Union, respectively. If a user requests a virtual directory tree for China, a virtual directory tree corresponding to the Chinese version is created for the user; if the user requests a virtual directory tree for the United States, a virtual directory tree corresponding to the US version is created for the user, and so on. In practical applications, more virtual directory trees can be preset; for example, the virtual directory tree versions can be further refined for each region.
[0039] The virtual directory tree created for the user's application request provides a "Add Node" button for each chapter node. Users can add chapter nodes or leaf nodes in each chapter node. The system adds chapter nodes or leaf nodes under the corresponding chapter node according to the user's operation of the "Add Node" button, and creates a corresponding upload interface for the leaf nodes added by the user.
[0040] If the virtual directory tree created for the user's application request has leaf nodes, each leaf node also has an upload interface for the user to upload files.
[0041] Users upload corresponding files through their upload interfaces at each leaf node. Each file uploaded by a user is mapped to the corresponding leaf node in the virtual directory tree based on the upload interface used.
[0042] The aforementioned specific address is generally a specific address in the system's cloud environment, such as... Figure 2 As shown, the system cloud will create a folder for each application. All files uploaded by the user for this application will be stored in this folder, and each file in this folder corresponds to a leaf node in the directory tree.
[0043] S2. After the user uploads all the files requested in this application based on the virtual directory tree, the system obtains a complete directory tree in which the leaf nodes have a one-to-one mapping relationship with the files uploaded by the user. Figure 3 A partial screenshot of a virtual directory tree in a sample is provided.
[0044] After the user uploads all the files for this application, they can click "Publish". The system will then execute steps S3-S5 to generate the final valid release package for the user. Figure 4 A partial screenshot of the final generated application release package is provided for a certain example.
[0045] S3. Obtain the application number and serial number through the directory tree and create the root path for the release file. For example, if the application number is x000001 and the serial number is 0000, a directory x000001 / 0000 will be created in the current working directory, and this directory will become the root directory for the release file.
[0046] S4. Starting from the root node of the directory tree, traverse each node downwards using a depth-first search algorithm. Child nodes will inherit the attributes of their parent nodes, such as chapter attributes, and a corresponding file path will be created for each node under the file root path.
[0047] For each chapter node, the system matches the folder name according to the pre-designed mapping relationship between chapter tree paths and folder names, and creates a folder with the corresponding folder name under the current file path. For example, the path " / m1" matches the folder name "m1", " / m1 / eu" matches the folder name "eu", and " / m1 / eu / 10CoverLeter" matches the folder name "10-cover".
[0048] Alternatively, create a folder in the current file path whose name is a combination of the current chapter's attributes. Chapter attributes include: country, active ingredient, manufacturer, formulation name, etc. If the chapter has non-empty attributes, you can combine the non-empty attribute values to generate a new folder name. For example, if the active ingredient attribute value is "df" and the manufacturer attribute value is "mf", the resulting folder name will be "df-mf". After obtaining the new folder name, validate the name, filter out characters that do not meet the specifications, and generate the final folder name. Create the folder in the current directory and set the current directory as the folder name.
[0049] For chapter nodes, a folder name is generated and a corresponding folder is created according to one of the two preset methods mentioned above. Regarding which method is used to determine the folder name for which chapter, this solution uses the second method if the chapter has a chapter attribute, and the first method if it doesn't. In practical applications, other preset methods can also be used to determine the corresponding folder name and create the corresponding folder for each chapter. For example, the first method can be used first, and if a match fails, the second method can be used; or the first method can be used for specific chapters, and the second method for other specific chapters, and so on.
[0050] Furthermore, for chapter nodes, if neither a chapter attribute nor a matching folder name can be found, the folder will not be created. Alternatively, the current chapter node's title can be filtered to generate a new folder name, and a folder with that name can be created in the current file path.
[0051] If a chapter node is automatically expanded by the user through the "Add Node" button, then there is no mapping relationship between the chapter path and the folder name. In this case, the second method described above will be used to generate the folder name, which is a combination of the current chapter attributes. If no chapter attributes exist, the title of the expanded node can be used to filter its characters, generating a new folder name. This folder will then be created in the current directory, and the current directory will be set as the folder name.
[0052] For leaf nodes, the filename is obtained based on the chapter they belong to and the automatic file naming rules for that chapter. The system pre-designs automatic file naming rules for different chapters. For example, the automatic file naming rule for the chapter m1 / eu / 10-cover is CC-cover-VAR.EXT, where CC is the country attribute value of the chapter, VAR is the variable name component of the node, and EXT is the file extension. Assuming CC is en, VAR is v, and EXT is pdf, the file would be automatically named en-cover-v.pdf. The system also retrieves the automatic filename rule based on the current node's path, and then combines this with attributes inherited from the parent node, the variable name component of the current node, and the file extension to form a new filename.
[0053] Subsequently, the corresponding file is downloaded from the specific address to the current file path and named with the previously determined filename. Since each leaf node corresponds to a file in the cloud folder, the system will download the corresponding file from the cloud to the current path and name it with the previously determined filename.
[0054] Preferably, for leaf nodes, when the user selects a custom name and the custom name is not empty, the user-defined name is used as the file name, and the file downloaded from the specific address is named with the user-defined file name;
[0055] Furthermore, upon obtaining the complete filename, the system filters the current filename by characters and checks if a file with the same name already exists in the current directory. If so, an incrementing number is added to the filename for renaming. For example, if a file with the same name as en-cover-v.pdf is found, it is renamed to en-cover-v-1.pdf. If another file with the same name still exists, it is renamed to en-cover-v-2.pdf, and so on, until there are no conflicts. Finally, a valid filename is obtained.
[0056] By creating a corresponding file path for each chapter node under the root file path, such as a tree chain ABCD where A, B, and C are chapter nodes, D is a leaf node, B is a child node of A, C is a child node of B, and D is a child node of C, then in the file path, the folder corresponding to B will be located under the folder corresponding to A, the folder corresponding to C will be located under the folder corresponding to B, and the file mapped to D will be downloaded to the folder C. For example, if the full path of a file is x000001 / 0000 / m1 / eu / 10-cover / en / en-cover-v.pdf, the file en-cover-vpdf corresponds to the leaf node of the en folder mapped to the chapter node, and the en folder corresponds to the child node of the chapter node corresponding to 10-cover, and so on.
[0057] S5. After traversing the entire directory tree, recursively search for empty folders under the file root path using a depth-first traversal algorithm and remove them, keeping only the folders containing files, to generate the final valid release package content.
[0058] By implementing the above scheme, combining the current node path and the inherited node attributes, and automatically generating file paths according to preset rules, the system can automatically organize the paths and names of the files included in the user's application. This can effectively reduce the workload of the applicant, improve the application efficiency, and the automatic generation of file paths and automatic naming of files through preset methods can effectively reduce the applicant's errors and resolve file path conflict issues.
[0059] The specific embodiments described in this example are merely illustrative of the spirit of the invention. Those skilled in the art can make various modifications or additions to the described embodiments or use similar methods to substitute them, without departing from the spirit of the invention or exceeding the scope defined by the appended claims.
Claims
1. A method for generating the file path of an eCTD document, characterized in that, The method includes: S1. Create a virtual directory tree containing the application number and serial number for the user's application request, allowing the user to upload files to a specific address; S2. Obtain a directory tree that maps to the files uploaded by the user; S3. Obtain the application number and serial number from the directory tree and create the root path for the release file; S4. Starting from the root node of the directory tree, traverse each node downwards and create a corresponding file path for each node under the file root path: For each chapter node, match the folder name according to the mapping relationship between the chapter tree path and the folder name, and create a folder with the corresponding folder name under the current file path; Alternatively, create a folder in the current file path whose name is a combination of the attributes of the current chapter; For leaf nodes, based on the chapter they are in, the file name is obtained according to the automatic file naming rules under different chapters, and the corresponding file is downloaded from a specific address to the current file path and named with the file name mentioned above. S5. After traversing all leaf nodes, generate the final valid release package content.
2. The method for generating the file path of an eCTD document according to claim 1, characterized in that, In step S1, the files uploaded by the user for this application request are uniformly stored in the aforementioned specific address; In step S2, each file uploaded by the user to a specific address corresponds to a leaf node in the directory tree.
3. The method for generating the file path of an eCTD document according to claim 2, characterized in that, In step S1, each leaf node of the created virtual directory tree has an upload interface for users to upload files. Furthermore, each file uploaded by a user is mapped to the corresponding leaf node of the virtual directory tree based on the upload interface used.
4. The method for generating the file path of an eCTD document according to claim 3, characterized in that, This method also includes, in step S1, each chapter node of the virtual directory tree provides a node addition button, and according to the user's operation of the node addition button, a new chapter node or leaf node is added under the corresponding chapter node, and a corresponding upload interface is created for the leaf node added by the user.
5. The method for generating the file path of an eCTD document according to any one of claims 1-4, characterized in that, In step S4, for chapter nodes, a folder name is generated and a corresponding folder is created according to one of the two methods mentioned above, based on a preset method. Furthermore, for chapter nodes, if there is neither a chapter attribute nor a matching folder name, the folder will not be created. Alternatively, based on the title of the current chapter node, filter its characters to generate a new folder name, and create a folder with that folder name in the current file path.
6. The method for generating the file path of an eCTD document according to claim 5, characterized in that, This method also includes recursively searching for and removing empty folders that have been generated under the file root path after traversing the entire directory tree.
7. The method for generating the file path of an eCTD document according to claim 1, characterized in that, In step S1, a corresponding virtual directory tree is created based on the application object selected by the user.
8. The method for generating the file path of an eCTD document according to claim 1, characterized in that, In step S4, the chapter attributes include any one or more of the following: country, active ingredient, manufacturer, and formulation name. The folder name is generated by combining all currently existing chapter attributes.
9. The method for generating the file path of an eCTD document according to claim 1, characterized in that, For leaf nodes, when the user selects a custom name and the custom name is not empty, the user-defined name is used as the file name, and the file downloaded from the specific address is named with the user-defined file name. When the complete file name is obtained, the current file name is filtered for characters and then checked to see if a file with the same name exists in the current file directory. If it does, an incrementing number is added to the file name to rename it.
10. An eCTD system, characterized in that, Used to perform the method according to any one of claims 1-9.