CN113139727B - Cosmetic human body efficacy test subject management system and method - Google Patents
Cosmetic human body efficacy test subject management system and method Download PDFInfo
- Publication number
- CN113139727B CN113139727B CN202110440922.4A CN202110440922A CN113139727B CN 113139727 B CN113139727 B CN 113139727B CN 202110440922 A CN202110440922 A CN 202110440922A CN 113139727 B CN113139727 B CN 113139727B
- Authority
- CN
- China
- Prior art keywords
- efficacy test
- subject
- module
- data
- cosmetic
- 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.)
- Active
Links
- 238000012360 testing method Methods 0.000 title claims abstract description 300
- 239000002537 cosmetic Substances 0.000 title claims abstract description 118
- 238000000034 method Methods 0.000 title claims abstract description 24
- 238000011160 research Methods 0.000 claims abstract description 59
- 238000012216 screening Methods 0.000 claims abstract description 33
- 206010067484 Adverse reaction Diseases 0.000 claims abstract description 31
- 230000006838 adverse reaction Effects 0.000 claims abstract description 31
- 238000012544 monitoring process Methods 0.000 claims abstract description 22
- 238000007405 data analysis Methods 0.000 claims abstract description 16
- 238000004458 analytical method Methods 0.000 claims description 15
- 238000001514 detection method Methods 0.000 claims description 12
- 238000004891 communication Methods 0.000 claims description 11
- 230000007717 exclusion Effects 0.000 claims description 8
- 238000011156 evaluation Methods 0.000 claims description 6
- 230000037308 hair color Effects 0.000 claims description 4
- 206010000496 acne Diseases 0.000 claims description 3
- 230000003370 grooming effect Effects 0.000 claims description 3
- 238000011084 recovery Methods 0.000 claims description 3
- 230000001960 triggered effect Effects 0.000 claims description 3
- 208000002874 Acne Vulgaris Diseases 0.000 claims description 2
- 208000001840 Dandruff Diseases 0.000 claims description 2
- 206010020751 Hypersensitivity Diseases 0.000 claims description 2
- 206010044625 Trichorrhexis Diseases 0.000 claims description 2
- 230000007815 allergy Effects 0.000 claims description 2
- 230000001153 anti-wrinkle effect Effects 0.000 claims description 2
- 238000004140 cleaning Methods 0.000 claims description 2
- 238000004332 deodorization Methods 0.000 claims description 2
- 239000003205 fragrance Substances 0.000 claims description 2
- 230000003658 preventing hair loss Effects 0.000 claims description 2
- 230000002265 prevention Effects 0.000 claims description 2
- 230000002747 voluntary effect Effects 0.000 claims description 2
- 230000002087 whitening effect Effects 0.000 claims description 2
- 230000003020 moisturizing effect Effects 0.000 claims 1
- 230000008520 organization Effects 0.000 claims 1
- 230000003716 rejuvenation Effects 0.000 claims 1
- 238000007726 management method Methods 0.000 description 36
- 230000002411 adverse Effects 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000001166 anti-perspirative effect Effects 0.000 description 1
- 239000003213 antiperspirant Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000007115 recruitment Effects 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 230000037072 sun protection Effects 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
Classifications
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q10/00—Administration; Management
- G06Q10/06—Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
- G06Q10/063—Operations research, analysis or management
- G06Q10/0631—Resource planning, allocation, distributing or scheduling for enterprises or organisations
- G06Q10/06313—Resource planning in a project environment
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q10/00—Administration; Management
- G06Q10/10—Office automation; Time management
- G06Q10/103—Workflow collaboration or project management
-
- 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
- G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
-
- 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
-
- Y—GENERAL 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
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
- Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
Landscapes
- Business, Economics & Management (AREA)
- Human Resources & Organizations (AREA)
- Engineering & Computer Science (AREA)
- Strategic Management (AREA)
- Entrepreneurship & Innovation (AREA)
- Economics (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Public Health (AREA)
- Primary Health Care (AREA)
- Medical Informatics (AREA)
- Marketing (AREA)
- Operations Research (AREA)
- Quality & Reliability (AREA)
- Tourism & Hospitality (AREA)
- Physics & Mathematics (AREA)
- General Business, Economics & Management (AREA)
- Epidemiology (AREA)
- Theoretical Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Educational Administration (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biodiversity & Conservation Biology (AREA)
- Game Theory and Decision Science (AREA)
- Development Economics (AREA)
- Data Mining & Analysis (AREA)
- Cosmetics (AREA)
- Management, Administration, Business Operations System, And Electronic Commerce (AREA)
Abstract
The invention provides a system and a method for managing a subject in a cosmetic human efficacy test. The cosmetic human efficacy test subject management system includes: the system comprises a research setting-up module, a subject screening module, a subject archive setting-up module, a data center module, an efficacy test scheme management module, a subject management module, a data center module, an adverse reaction monitoring module, a data analysis module and a data sharing module. The subject management system for the human efficacy test of the cosmetics improves the accuracy of the efficacy test data. And the efficacy test scheme management module is used for carrying out efficient adjustment decision on the efficacy test scheme according to the efficacy test file.
Description
Technical Field
The invention relates to the field of cosmetic efficacy claiming evaluation tests, in particular to a system and a method for managing a subject in a cosmetic human efficacy test.
Background
With the release of the "evaluation guidelines for the efficacy of cosmetics" drafted by the national drug administration, the responsible subjects should carry out scientific tests and reasonable analyses on the efficacy claims of cosmetics under normal, reasonable and foreseeable use conditions, and make corresponding evaluation conclusions, wherein the human efficacy test is one of the most important scientific basis for the efficacy claims of cosmetics. However, due to the characteristics of long service cycle, high service frequency, accurate service area and the like of cosmetics, inspection work is difficult to develop, low compliance of the cosmetics in the human efficacy test research process is caused, and the accuracy, reliability and integrity of research data cannot be effectively ensured.
At present, as the efficacy of the cosmetic industry declares that the work is still in the starting stage, a high-efficiency and safe method for managing the human efficacy test subjects of cosmetics is still lacking, and at present, no effective subject management system provides support for the human efficacy test and subject management of cosmetics, and cannot provide support for the accurate analysis of the human efficacy test data of cosmetics.
Therefore, there is a need to develop a management method and system with higher accuracy, reliability and integrity to meet the requirements of human efficacy tests of cosmetics.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide a system and a method for managing a cosmetic human body efficacy test subject. The subject management system for the human efficacy test of the cosmetics improves the accuracy of the efficacy test data. And the efficacy test scheme management module is used for carrying out efficient adjustment decision on the efficacy test scheme according to the efficacy test file.
To achieve the purpose, the invention adopts the following technical scheme:
in a first aspect, the present invention provides a cosmetic human efficacy test subject management system comprising:
the research setting module is used for setting research information for performing human body efficacy test of cosmetics;
a subject screening module connected to the study setup module for screening subjects into a group from a volunteer database according to the study information;
the subject file establishing module is connected with the research establishing module and the subject screening module and is used for establishing a cosmetic human body efficacy test file of each subject and uploading the cosmetic human body efficacy test file to the data center module;
the data center module is respectively connected with the research setting-up module and the subject file setting-up module and is used for storing the research information and one or at least two corresponding cosmetic human body efficacy test files;
the efficacy test scheme management module is connected with the data center module and is used for adjusting the human efficacy test scheme according to the research information and the efficacy test data (human efficacy test file);
the subject management module is connected with the data center module and is used for pushing the cosmetic sample use information to the subject according to the efficacy test scheme, performing an efficacy test to obtain test data of the required subject, and uploading the test data in the efficacy test file of the subject in real time;
the adverse reaction monitoring module is connected with the data center module and is used for periodically monitoring the efficacy test data and the adverse reaction data and adjusting the human efficacy test scheme by the research information and the monitoring test data;
the data analysis module is connected with the data center module and is used for analyzing the human body efficacy test file to obtain cosmetic human body efficacy test data;
the data sharing module is connected with the data center module and is used for providing the human body efficacy test file for the applicant of efficacy test research and relevant national supervision authorities in an internet communication mode.
Preferably, the study information includes any one or a combination of at least two of cosmetic sample information, a standard of use of a cosmetic sample, a test purpose, a subject inclusion standard, or a subject exclusion standard.
Preferably, the subject screening module comprises:
the subject screening unit is used for screening the volunteer database according to the research information and screening out undetermined personnel meeting the subject requirement;
the subject detection unit is connected with the subject screening unit and is used for checking the undetermined personnel, and baseline data required by efficacy tests of the undetermined personnel are obtained;
the subject removing unit is connected with the subject detecting unit and used for removing undetermined personnel which do not accord with the research information according to the falling-off and replacement principle of the subject;
and the subject group-entering unit is connected with the subject detection unit and is used for carrying out group-entering record on the subjects.
Preferably, the subject profile creation module includes:
an acceptance unit for acquiring basic information of each subject according to the volunteer database;
and the filing unit is connected with the receiving unit and is used for establishing an efficacy test file of each subject based on basic information of the subject, wherein the basic information comprises personal basic information of the subject and baseline data of the corresponding subject.
Preferably, the data center module includes:
the storage unit is used for receiving the efficacy test files and storing the efficacy test files in a classified mode according to the research information;
the scheme presetting unit is connected with the storage unit and is used for generating an initial human body efficacy test research scheme of the cosmetics according to the use standard of the initial research sample provided by the applicant, and adding the initial human body efficacy test research scheme to the corresponding human body efficacy test file to serve as a human body efficacy test research scheme;
and the efficacy test data unit is used for receiving the efficacy test data uploaded by the subject management module and carrying out standardized arrangement on the efficacy test data.
Preferably, the efficacy test regimen management module comprises:
the data acquisition unit is used for regularly or periodically extracting effective data from the efficacy test file;
the data analysis unit is connected with the data acquisition unit and used for analyzing and adjusting the test information by combining the baseline data and the adverse reaction in the efficacy test file.
The scheme adjusting unit is connected with the data analyzing unit and used for uploading the adjusted efficacy test scheme to the efficacy test file, and updating the efficacy test file as an alternative efficacy test scheme on the basis of keeping the initial efficacy test scheme data.
Preferably, the subject management module comprises:
the cosmetic sample use information pushing unit is used for pushing the use reminding and the use method of the cosmetic sample to the subject at regular time according to the use standard of the sample in an internet communication mode during the efficacy test;
the cosmetic sample management unit is used for carrying out sample use management and sample recovery on the subject according to the efficacy test scheme so as to acquire sample use information;
and the subject detection unit is used for regularly or periodically collecting data of the subjects according to the efficacy study scheme to obtain efficacy test data and uploading the efficacy test data into the efficacy test file in real time.
Preferably, the adverse reaction monitoring module includes:
the adverse reaction monitoring unit is used for monitoring whether adverse reaction is triggered or not and the probability of occurrence of the adverse reaction in the efficacy test and uploading the adverse reaction to the efficacy test file in real time; and adjusting the efficacy test scheme in real time according to the efficacy test data.
Preferably, the data analysis module includes:
the efficacy claiming analysis unit is used for analyzing the human efficacy test file to obtain a test result of efficacy claiming effectiveness of the cosmetic sample;
the safety analysis unit is used for analyzing the human body efficacy test file to obtain a test result of the safety of the cosmetic sample according to efficacy claims.
In a second aspect, the present invention provides a method for managing a cosmetic human efficacy test subject, the method being performed using the cosmetic human efficacy test subject management system according to the first aspect, specifically comprising the steps of:
(1) A research setting module is adopted to set up research information for carrying out human body efficacy test of cosmetics;
(2) Screening out the subjects in the group from the volunteer database according to the research information by adopting a subject screening module;
(3) A subject file establishing module is adopted to establish a cosmetic human body efficacy test file of each subject, and the cosmetic human body efficacy test files are uploaded to a data center module;
(4) A data center module is adopted to store the research information and one or at least two corresponding cosmetic human body efficacy test files;
(5) Adopting an efficacy test scheme management module, pushing cosmetic sample use information to a subject according to an efficacy test scheme, performing an efficacy test to obtain test data of a required subject, and uploading the test data in a belonging efficacy test file in real time;
(6) Analyzing the human body efficacy test file by adopting an adverse reaction monitoring module to obtain cosmetic human body efficacy test data;
(7) Analyzing the human body efficacy test file by adopting a data analysis module to obtain cosmetic human body efficacy test data;
(8) And a data sharing module is adopted to provide the human body efficacy test file for the applicant of efficacy test research and relevant national supervision authorities in an internet communication mode.
Compared with the prior art, the invention has the following beneficial effects:
the efficacy test file of the data center module is adopted to effectively monitor the testing process of the cosmetic sample. The subject management module improves subject compliance during long-term sample efficacy testing and improves accuracy of efficacy test data. And the efficacy test scheme management module is used for carrying out efficient adjustment decision on the efficacy test scheme according to the efficacy test file. The subject management system and method for the human body efficacy test of the cosmetics improve the accuracy of the data of the human body efficacy test of the cosmetics and improve the management efficiency of a research center on the human body efficacy test of the cosmetics.
Drawings
Fig. 1 is a schematic structural diagram of a subject management system for human efficacy test of cosmetics according to the present invention.
Detailed Description
The technical scheme of the invention is further described below by the specific embodiments with reference to the accompanying drawings. It should be apparent to those skilled in the art that the detailed description is merely provided to aid in understanding the invention and should not be taken as limiting the invention in any way.
Example 1
The present embodiment provides a cosmetic human efficacy test subject management system, as shown in fig. 1, comprising:
a research setting module 1 for setting research information for performing a cosmetic human body efficacy test;
a subject screening module 2 connected to the study setup module 1 for screening subjects into a group from a volunteer database according to study information;
a subject file establishing module 3, connected to the study establishing module 1 and the subject screening module 2, for establishing a cosmetic human body efficacy test file of each subject, and uploading the cosmetic human body efficacy test file to a data center module;
the data center module 4 is respectively connected with the research setting-up module 1 and the subject file setting-up module 3 and is used for storing the research information and one or more corresponding cosmetic human body efficacy test files;
the subject management module 5 is connected with the data center module 4 and is used for pushing the cosmetic sample use information to the subject according to the efficacy test scheme, performing an efficacy test to obtain test data of the required subject, and uploading the test data in the efficacy test file of the subject in real time;
the adverse reaction monitoring module 6 is connected with the data center module 4 and is used for periodically monitoring the efficacy test data and the adverse reaction data and adjusting the human efficacy test scheme by the research information and the monitoring test data;
the efficacy test scheme management module 7 is connected with the data center module 4 and used for adjusting the human efficacy test scheme according to the research information and the efficacy test data;
the data analysis module 8 is connected with the data center module 4 and is used for analyzing the human body efficacy test file to obtain cosmetic human body efficacy test data;
the data sharing module 9 is connected with the affiliated data center module 4 and is used for providing the human body efficacy test file for the applicant of the efficacy test research and the relevant national supervision authorities through an internet communication mode.
In a preferred embodiment of the invention, the study information includes cosmetic sample information, test purpose, subject inclusion and exclusion criteria.
In particular, in this example, the cosmetic sample information includes: sample name (trade name registered in the cosmetic registration and docket inspection information management system), sample number, sample specification, sample status, sample package, or sample provider, or a combination of at least two.
Preferably, the use standard of the cosmetic sample includes any one or a combination of at least two of a sample use method, a use site, a use frequency, a use period, or a use notice.
Preferably, the test purpose includes any one or a combination of at least two of cleaning, makeup removal, moisturization, cosmetic grooming, hair styling, fragrance, hair care, sun protection, spot removal, whitening (physical masking only), anti-wrinkle, tightening, repair, soothing, acne removal (including blackhead removal), oil control, exfoliating, body grooming (including antiperspirant), hair coloring, hair waving, hair loss prevention, hair breakage prevention, anti-dandruff, hair color care, hair removal, deodorization, shaving aid, shaving, or others.
Preferably, the subject inclusion criteria include any one or a combination of at least two of age, gender, skin quality, compliance, voluntary participation, or other satisfaction of particular participation conditions.
Preferably, the subject exclusion criteria include any one or a combination of at least two of pregnant or lactating women, recent birth control, skin history, cosmetic and pharmaceutical allergy sufferers, and participation in other clinical trials in the last three months or other clinical evaluations deemed unsuitable for participation in the trial.
In a preferred embodiment of the present invention, the subject screening module 2 comprises:
the subject screening unit is used for screening the volunteer database according to the research information and screening out undetermined personnel meeting the subject requirement;
the subject detection unit is connected with the subject screening unit and is used for checking the undetermined personnel, and baseline data required by efficacy tests of the undetermined personnel are obtained;
the subject removing unit is connected with the subject detecting unit and used for removing undetermined personnel which do not accord with the research information according to the falling-off and replacement principle of the subject;
and the subject group-entering unit is connected with the subject detection unit and is used for carrying out group-entering record on the subjects.
In the embodiment, the recruitment time of the subjects is greatly shortened through the screening of the volunteer database, the screening rate is improved, the period of the human efficacy test of the cosmetics is shortened on the premise of guaranteeing the research quality, and the product characteristics of the cosmetics quick-release products are better matched.
In a preferred embodiment of the present invention, the subject archive creation module 3 comprises:
an acceptance unit for acquiring basic information of each subject according to the volunteer database;
a profiling unit connected with the receiving unit, and establishing efficacy test files of each subject based on basic information of the subjects, wherein the basic information comprises personal basic information of the subjects and baseline data of the corresponding subjects;
specifically, in this example, the subject profile creation module 3 creates, for each subject's human efficacy test profile, information of the immediate subject during the complete human efficacy test, including: basic information data of the subject, efficacy test data, adverse events, serious adverse events and the like. The subject's efficacy test data during the study will be uploaded in real time into the subject's efficacy test profile.
In a preferred embodiment of the present invention, the data center module 4 comprises:
the storage unit is used for receiving the efficacy test files and storing the efficacy test files in a classified mode according to the research information;
the scheme presetting unit is connected with the storage unit and is used for generating an initial human body efficacy test research scheme of the cosmetics according to the use standard of the initial research sample provided by the applicant, and adding the initial human body efficacy test research scheme to the corresponding human body efficacy test file to serve as a human body efficacy test research scheme;
and the efficacy test data unit is used for receiving the efficacy test data uploaded by the subject management module and carrying out standardized arrangement on the efficacy test data.
In particular, in this example, the study protocol according to the initial human efficacy test includes: test information, test time, test instruments, test environments, test procedures, data analysis methods and the like. More specifically in this example, the test information includes: sample application method, test area, follow-up time; subject inclusion and exclusion criteria included: subject inclusion criteria, subject exclusion criteria; the test time includes: test start time, test completion time; the test environment includes: testing temperature environment and humidity environment.
In a preferred embodiment of the present invention, the subject management 5 module comprises:
the cosmetic sample use information pushing unit is used for pushing the use reminding and the use method of the cosmetic sample to the subject at regular time according to the use standard of the sample in an internet communication mode during the efficacy test;
the cosmetic sample management unit is used for carrying out sample use management and sample recovery on the subject according to the efficacy test scheme so as to acquire sample use information;
the subject detection unit is used for regularly or periodically collecting data of a subject according to the efficacy study scheme to obtain efficacy test data and uploading the efficacy test data into the efficacy test file in real time;
in this example, the internet communication mode of the cosmetic sample application information pushing unit includes a short message, a micro-message applet, and the like. The subject detection unit collects data of the subjects by researching the human body efficacy test data as evidence for managing the subjects.
In a preferred embodiment of the present invention, the adverse reaction monitoring module 6 includes:
the adverse reaction monitoring unit is used for monitoring whether adverse reaction is triggered or not and the probability of occurrence of the adverse reaction in the efficacy test and uploading the adverse reaction to the efficacy test file in real time; and adjusting the efficacy test scheme in real time according to the efficacy test data.
In this example, specifically, the possible adverse reaction is detected by means of manual detection or internet communication detection, if the adverse reaction occurs, a researcher is reminded to perform intervention treatment on the possible adverse reaction, an uploading efficacy test file is recorded in time, and the efficacy test scheme is adjusted.
In a preferred embodiment of the present invention, the efficacy test regimen management module 7 comprises:
the data acquisition unit is used for regularly or periodically extracting effective data from the efficacy test file;
the data analysis unit is connected with the data acquisition unit and used for analyzing and adjusting the test information by combining the baseline data and the adverse reaction in the efficacy test file.
The scheme adjusting unit is connected with the data analyzing unit and used for uploading the adjusted efficacy test scheme to the efficacy test file, and updating the efficacy test file as an alternative efficacy test scheme on the basis of keeping the initial efficacy test scheme data.
In a preferred embodiment of the present invention, the data analysis module 8 includes:
the efficacy claiming analysis unit is used for analyzing the human efficacy test file to obtain a test result of the efficacy claiming effectiveness of the sample;
the safety analysis unit is used for analyzing the human body efficacy test file to obtain a test result of the sample efficacy claim safety.
In this example, the efficacy claiming analysis refers to the analysis of the efficacy index of the data analysis module 8 on the efficacy test file during the execution of the human efficacy test of the cosmetic sample, and the efficacy of the human efficacy test scheme of the cosmetic is analyzed and evaluated according to the comparison of the efficacy index and the baseline index. More specifically, in this example, the validity index includes: analysis of moisture content of skin around eyes, analysis of area of wrinkles around eyes, and the like.
In this example, the safety analysis refers to the analysis of safety indexes of the efficacy test file by the data analysis module 8 during the execution of the human efficacy test of the cosmetic sample, and the analysis and evaluation of safety of the human efficacy test scheme of the cosmetic.
Example 2
The invention provides a method for managing a cosmetic human body efficacy test subject, which is carried out by adopting a cosmetic human body efficacy test subject management system provided by an embodiment 1, and specifically comprises the following steps:
(1) Designing a test study according to the efficacy claim by adopting a study setting module 1, wherein test study information is added into a human efficacy test subject management system, and the study information comprises cosmetic sample information, test purposes, subject inclusion and exclusion criteria;
(2) Screening out qualified subjects according to the study information by adopting a subject screening module 2, and checking to establish a baseline;
(3) A subject file establishing module 3 is adopted to establish a cosmetic human body efficacy test file of each subject, and the cosmetic human body efficacy test files are uploaded to a data center module;
(4) The human body efficacy test file of the data center module 4 is adopted to effectively record and monitor the cosmetic sample test process, the method comprises the steps of establishing the human body efficacy test file, setting a human body efficacy test scheme, and testing by a human body efficacy test management system according to the efficacy test file;
(5) Adopting an efficacy test scheme management module, pushing cosmetic sample use information to a subject according to an efficacy test scheme, performing an efficacy test to obtain test data of a required subject, and uploading the test data in a belonging efficacy test file in real time;
(6) Analyzing the human body efficacy test file by adopting an adverse reaction monitoring module to obtain cosmetic human body efficacy test data;
(7) Analyzing the human body efficacy test file by adopting a data analysis module to obtain cosmetic human body efficacy test data;
(8) And a data sharing module is adopted to provide the human body efficacy test file for the applicant of efficacy test research and relevant national supervision authorities in an internet communication mode.
The scheme in the embodiment improves the accuracy of the human body efficacy test data of the cosmetics and improves the management efficiency of the research center on the human body efficacy test of the cosmetics.
Applicant states that the present invention is described by way of the above examples as a cosmetic human efficacy test subject management system and method, but the present invention is not limited to, i.e., it is not meant that the present invention must be practiced in dependence upon, the above examples. It should be apparent to those skilled in the art that any modification of the present invention, equivalent substitution of raw materials for the product of the present invention, addition of auxiliary components, selection of specific modes, etc., falls within the scope of the present invention and the scope of disclosure.
Claims (7)
1. The cosmetic human body efficacy test subject management system is characterized in that the cosmetic human body efficacy test subject management system is as follows:
the research setting module is used for setting research information for performing human body efficacy test of cosmetics;
a subject screening module connected to the study setup module for screening subjects into a group from a volunteer database according to the study information;
the subject file establishing module is connected with the research establishing module and the subject screening module and is used for establishing a cosmetic human body efficacy test file of each subject and uploading the cosmetic human body efficacy test file to the data center module;
the data center module is respectively connected with the research setting-up module and the subject file setting-up module and is used for storing the research information and one or at least two corresponding cosmetic human body efficacy test files;
the efficacy test scheme management module is connected with the data center module and used for adjusting the human efficacy test scheme according to the research information and the efficacy test data;
the subject management module is connected with the data center module and is used for pushing the cosmetic sample use information to the subject according to the efficacy test scheme, performing an efficacy test to obtain test data of the required subject, and uploading the test data in the efficacy test file of the subject in real time;
the adverse reaction monitoring module is connected with the data center module and is used for periodically monitoring the efficacy test data and the adverse reaction data and adjusting the human efficacy test scheme by the research information and the monitoring test data;
the data analysis module is connected with the data center module and is used for analyzing the human body efficacy test file to obtain cosmetic human body efficacy test data;
the data sharing module is connected with the data center module and is used for providing the human body efficacy test file for an applicant of efficacy test research and a relevant national supervision organization in an internet communication mode;
the study information includes any one or a combination of at least two of cosmetic sample information, a standard of use of a cosmetic sample, a test purpose, a subject inclusion standard, or a subject exclusion standard;
the efficacy test protocol management module comprises:
the data acquisition unit is used for regularly or periodically extracting effective data from the efficacy test file;
the data analysis unit is connected with the data acquisition unit and used for analyzing and adjusting the test information by combining the baseline data and adverse reaction in the efficacy test file;
the scheme adjusting unit is connected with the data analyzing unit and used for uploading the adjusted efficacy test scheme to the efficacy test file, and updating the efficacy test file as an alternative efficacy test scheme on the basis of keeping the initial efficacy test scheme data;
the subject screening module includes:
the subject screening unit is used for screening the volunteer database according to the research information and screening out undetermined personnel meeting the subject requirement;
the subject detection unit is connected with the subject screening unit and is used for checking the undetermined personnel, and baseline data required by efficacy tests of the undetermined personnel are obtained;
the subject removing unit is connected with the subject detecting unit and used for removing undetermined personnel which do not accord with the research information according to the falling-off and replacement principle of the subject;
a subject group-entering unit connected with the subject detection unit for performing group-entering record on the subject;
the subject profile creation module includes:
an acceptance unit for acquiring basic information of each subject according to the volunteer database;
a profiling unit connected with the receiving unit, and establishing efficacy test files of each subject based on basic information of the subjects, wherein the basic information comprises personal basic information of the subjects and baseline data of the corresponding subjects;
the data center module includes:
the storage unit is used for receiving the efficacy test files and storing the efficacy test files in a classified mode according to the research information;
the scheme presetting unit is connected with the storage unit and is used for generating an initial human body efficacy test research scheme of the cosmetics according to the use standard of the initial research sample provided by the applicant, and adding the initial human body efficacy test research scheme to the corresponding human body efficacy test file to serve as a human body efficacy test research scheme;
the efficacy test data unit is used for receiving the efficacy test data uploaded by the subject management module and carrying out standardized arrangement on the efficacy test data;
the subject management module includes:
the cosmetic sample use information pushing unit is used for pushing the use reminding and the use method of the cosmetic sample to the subject at regular time according to the use standard of the sample in an internet communication mode during the efficacy test;
the cosmetic sample management unit is used for carrying out sample use management and sample recovery on the subject according to the efficacy test scheme so as to acquire sample use information;
the subject detection unit is used for regularly or periodically collecting data of a subject according to the efficacy study scheme to obtain efficacy test data and uploading the efficacy test data into the efficacy test file in real time;
the adverse reaction monitoring module comprises:
the adverse reaction monitoring unit is used for monitoring whether adverse reaction is triggered or not and the probability of occurrence of the adverse reaction in the efficacy test and uploading the adverse reaction to the efficacy test file in real time; adjusting the efficacy test scheme in real time according to the efficacy test data;
the data analysis module comprises:
the efficacy claiming analysis unit is used for analyzing the human efficacy test file to obtain a test result of efficacy claiming effectiveness of the cosmetic sample;
the safety analysis unit is used for analyzing the human body efficacy test file to obtain a test result of the safety of the cosmetic sample according to efficacy claims.
2. The cosmetic human efficacy test subject management system of claim 1, wherein the cosmetic sample information comprises any one or a combination of at least two of a sample name, a sample number, a sample specification, a sample status, a sample package, or a sample provider.
3. The cosmetic human efficacy test subject management system of claim 1, wherein the criteria for use of the cosmetic sample comprises any one or a combination of at least two of a sample use method, a use site, a frequency of use, a period of use, or a notice of use.
4. The cosmetic human efficacy test subject management system of claim 1, wherein the test purpose comprises any one or a combination of at least two of cleaning, makeup removal, moisturizing, cosmetic grooming, hair styling, fragrance, hair care, sunscreening, spot removal, whitening, anti-wrinkle, tightening, rejuvenation, soothing, acne removal, oil control, exfoliating, body refreshing, hair coloring, hair perming, hair loss prevention, hair breakage prevention, anti-dandruff, hair color care, hair removal, deodorization, or auxiliary shaving.
5. The cosmetic human efficacy test subject management system of claim 1, wherein the subject inclusion criteria comprises any one or a combination of at least two of age, gender, skin, compliance, voluntary participation, or other meeting specific participation conditions.
6. The cosmetic human efficacy test subject management system of claim 1, wherein the subject exclusion criteria comprises any one or a combination of at least two of pregnant or lactating women, recent birth control planners, skin history people, people with cosmetic and pharmaceutical allergies, people with participation in other clinical trials in the last three months, or other clinical evaluations that are considered unsuitable for participation in the trial.
7. A method for managing a cosmetic human efficacy test subject, characterized in that the method is performed by using the cosmetic human efficacy test subject management system according to any one of claims 1 to 6, comprising the steps of:
(1) A research setting module is adopted to set up research information for carrying out human body efficacy test of cosmetics;
(2) Screening out the subjects in the group from the volunteer database according to the research information by adopting a subject screening module;
(3) A subject file establishing module is adopted to establish a cosmetic human body efficacy test file of each subject, and the cosmetic human body efficacy test files are uploaded to a data center module;
(4) A data center module is adopted to store the research information and one or at least two corresponding cosmetic human body efficacy test files;
(5) Adopting an efficacy test scheme management module, pushing cosmetic sample use information to a subject according to an efficacy test scheme, performing an efficacy test to obtain test data of a required subject, and uploading the test data in a belonging efficacy test file in real time;
(6) Analyzing the human body efficacy test file by adopting an adverse reaction monitoring module to obtain cosmetic human body efficacy test data;
(7) Analyzing the human body efficacy test file by adopting a data analysis module to obtain cosmetic human body efficacy test data;
(8) And a data sharing module is adopted to provide the human body efficacy test file for the applicant of efficacy test research and relevant national supervision authorities in an internet communication mode.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110440922.4A CN113139727B (en) | 2021-04-23 | 2021-04-23 | Cosmetic human body efficacy test subject management system and method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110440922.4A CN113139727B (en) | 2021-04-23 | 2021-04-23 | Cosmetic human body efficacy test subject management system and method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN113139727A CN113139727A (en) | 2021-07-20 |
| CN113139727B true CN113139727B (en) | 2024-01-16 |
Family
ID=76813700
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110440922.4A Active CN113139727B (en) | 2021-04-23 | 2021-04-23 | Cosmetic human body efficacy test subject management system and method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113139727B (en) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103164823A (en) * | 2011-12-13 | 2013-06-19 | 天津阿贝斯努科技有限公司 | Medicine clinical test supervision and administration system |
| CN104318355A (en) * | 2014-10-11 | 2015-01-28 | 广东省生物制品与药物研究所 | Vaccine clinical trial management method and system |
| CN105550532A (en) * | 2016-02-19 | 2016-05-04 | 南京迈拓医药科技有限公司 | Management system applied to medical clinical test |
| CN107247864A (en) * | 2017-04-18 | 2017-10-13 | 上海交通大学附属第六人民医院 | Clinical drug trials and subject's management system and method |
| CN107480456A (en) * | 2017-08-22 | 2017-12-15 | 浙江大学医学院附属第医院 | clinical trial management method and system |
-
2021
- 2021-04-23 CN CN202110440922.4A patent/CN113139727B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103164823A (en) * | 2011-12-13 | 2013-06-19 | 天津阿贝斯努科技有限公司 | Medicine clinical test supervision and administration system |
| CN104318355A (en) * | 2014-10-11 | 2015-01-28 | 广东省生物制品与药物研究所 | Vaccine clinical trial management method and system |
| CN105550532A (en) * | 2016-02-19 | 2016-05-04 | 南京迈拓医药科技有限公司 | Management system applied to medical clinical test |
| CN107247864A (en) * | 2017-04-18 | 2017-10-13 | 上海交通大学附属第六人民医院 | Clinical drug trials and subject's management system and method |
| CN107480456A (en) * | 2017-08-22 | 2017-12-15 | 浙江大学医学院附属第医院 | clinical trial management method and system |
Also Published As
| Publication number | Publication date |
|---|---|
| CN113139727A (en) | 2021-07-20 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| KR100874825B1 (en) | Information providing method and system of customized cosmetics using skin gene information | |
| Ebner-Priemer et al. | State affective instability in borderline personality disorder assessed by ambulatory monitoring | |
| CA2736615C (en) | Method for classifying and treating physiologic brain imbalances using quantitative eeg | |
| Palomäki et al. | Brain oscillatory 4–35 Hz EEG responses during an n-back task with complex visual stimuli | |
| US20110160545A1 (en) | Electronic investigative device and method for identifying the truth | |
| JP7082347B2 (en) | Health measurement method, health judgment device and hair health diagnosis system | |
| Güthlin | Response Shift: alte Probleme der Veränderungsmessung, neu angewendet auf gesundheitsbezogene Lebensqualität | |
| KR20110105571A (en) | One's personal customized skincare system | |
| Cohen | The cross‐section trichometer: a new device for measuring hair quantity, hair loss, and hair growth | |
| Kim et al. | Immediate and delayed auditory feedback in declarative learning: An examination of the feedback related event related potentials | |
| CN113139727B (en) | Cosmetic human body efficacy test subject management system and method | |
| Tsuboi et al. | Randomized clinical trial comparing 5% and 1% topical minoxidil for the treatment of androgenetic alopecia in Japanese men | |
| Corazza et al. | Contact sensitization to emulsifying agents: an underrated issue? | |
| Piérard et al. | Scleroderma: skin stiffness assessment using the stress–strain relationship under progressive suction | |
| Penaranda et al. | Temporal factors of EEG and artificial neural network classifiers of mental workload | |
| CN116682163A (en) | Emotion recognition-based medicine curative effect prediction method, device and equipment | |
| Picard et al. | Oro-facial motor assessment: validation of the MBLF protocol in facial palsy | |
| Gaines et al. | Reimagining Hair Science: A New Approach to Classify Curly Hair Phenotypes via New Quantitative Geometric and Structural Mechanical Parameters | |
| Kim et al. | Double-blind randomized placebo-controlled study of the efficacy and safety of hair loss prevention shampoo containing salicylic acid, panthenol, and niacinamide in alopecia patients | |
| De Unamuno et al. | Descriptive study of sensitization to methylchloroisothiazolinone and methylisothiazolinone in a skin allergy unit | |
| Sharma et al. | Multivariate EEG signal analysis for early prediction of epileptic seizure | |
| Klonowski et al. | Application of chaos theory and fractal analysis for EEG-signal processing in patients with seasonal affective disorder | |
| Whiston et al. | Examining stress and residual symptoms in remitted and partially remitted depression using a wearable electrodermal activity device: A pilot study | |
| Bavkar et al. | Detection of alcoholics using eeg and emd domain statistical features | |
| Crippa et al. | Occupational dermatitis in a highly industrialized Italian region: the experience of four occupational health departments |
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 | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |