CN113139727A - Cosmetic human body efficacy test subject management system and method - Google Patents
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Abstract
The invention provides a cosmetic human body efficacy test subject management system and method. The cosmetic human body efficacy test subject management system comprises: the system comprises a research establishment module, a subject screening module, a subject archive establishment 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 cosmetic human body efficacy test subject management system improves the accuracy of efficacy test data. And the efficacy test scheme management module carries 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 declaration evaluation tests, in particular to a cosmetic human body efficacy test subject management system and method.
Background
With the release of the 'guide principle of evaluating the efficacy of cosmetics' drafted by the State drug administration, the responsible subject scientifically tests and reasonably analyzes the efficacy of cosmetics under normal, reasonable and foreseeable use conditions, and makes corresponding evaluation conclusions, wherein the human body efficacy test is one of the most important scientific bases for the efficacy of cosmetics. However, due to the characteristics of long service cycle, high use frequency, accurate use region and the like of the cosmetics, the inspection work is difficult to carry out, so that the low compliance of the cosmetics in the human body efficacy test research process is caused, and the accuracy, reliability and integrity of the research data can not be effectively ensured.
At present, because the efficacy declaration work in the cosmetics industry is still in the starting stage, an efficient and safe method for managing the cosmetic human body efficacy test subject is still lacked, and an effective subject management system is not available at present for providing support for the cosmetic human body efficacy test and the subject management, and cannot provide support for accurate analysis of the cosmetic human body efficacy test data.
Therefore, there is a need to develop a management method and system with higher accuracy, reliability and integrity to meet the requirement of the cosmetic human efficacy test.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a cosmetic human body efficacy test subject management system and method. The cosmetic human body efficacy test subject management system improves the accuracy of efficacy test data. And the efficacy test scheme management module carries out efficient adjustment decision on the efficacy test scheme according to the efficacy test file.
In order 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 establishment module is used for establishing research information for testing the cosmetic human body efficacy test;
the subject screening module is connected with the research setting module and used for screening the grouped subjects from the volunteer database according to the research information;
the subject file establishing module is connected with the research establishing module and the subject screening module and 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 establishment module and the subject file establishment 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 body efficacy test scheme according to the research information and efficacy test data (human body efficacy test files);
the subject management module is connected with the data center module and used for pushing the use information of the cosmetic samples to the subjects according to the efficacy test scheme, performing efficacy test to obtain test data of the required subjects and uploading the test data to the efficacy test files in real time;
the adverse reaction monitoring module is connected with the data center module and is used for regularly monitoring the efficacy test data and the adverse reaction data and adjusting the research information and the monitoring test data to the human body efficacy test scheme;
the data analysis module is connected with the data center module and used for analyzing the human body efficacy test file to obtain cosmetic human body efficacy test data;
and the data sharing module is connected with the data center module and used for providing the human body efficacy test file to an applicant and a related national regulatory agency of efficacy test research in an internet communication mode.
Preferably, the research information includes any one of or a combination of at least two of cosmetic sample information, use criteria of the cosmetic sample, purpose of the test, subject inclusion criteria, or subject exclusion criteria.
Preferably, the subject screening module comprises:
the subject screening unit is used for screening a volunteer database according to the research information and screening out undetermined persons meeting the requirements of the subject;
the test unit of the testee is connected with the screening unit of the testee and is used for checking the personnel to be determined and obtaining the baseline data required by the efficacy test of the personnel to be determined;
the subject removing unit is connected with the subject detecting unit and is used for removing the undetermined person which does not accord with the research information according to the falling and replacement principle of the subject;
and the subject grouping unit is connected with the subject detection unit and records the grouping of the subjects.
Preferably, the subject profile creation module comprises:
the accepting unit is used for acquiring basic information of each subject according to the volunteer database;
and the profiling unit is connected with the receiving unit and establishes an efficacy test file of each subject on the basis of the basic information of the subject, wherein the basic information comprises the personal basic information of the subject and the baseline data of the corresponding subject.
Preferably, the data center module comprises:
the storage unit is used for receiving the efficacy test files and storing the efficacy test files in a classified manner according to the research information;
the scheme presetting unit is connected with the storage unit and used for generating an initial human body efficacy test research scheme of 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 the 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 protocol management module comprises:
the data acquisition unit is used for regularly or periodically extracting effective data from the efficacy test file;
and the data analysis unit is connected with the data acquisition unit and is used for analyzing and adjusting the test information by combining the baseline data and the adverse reactions in the efficacy test file.
And the scheme adjusting unit is connected with the data analysis unit and is used for uploading the adjusted efficacy test scheme to the efficacy test file and updating the efficacy test scheme as a replacement 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 regularly pushing use reminding and use methods of the cosmetic samples to the subjects according to the use standards of the samples in the efficacy test period in an internet communication mode;
the cosmetic sample management unit is used for carrying out sample use management and sample recovery on the testee according to the efficacy test scheme so as to obtain sample use information;
and the test subject detection unit is used for regularly or periodically collecting data of the test subjects according to the efficacy research scheme to obtain efficacy test data and uploading the efficacy test data to the efficacy test archive in real time.
Preferably, the adverse reaction monitoring module comprises:
the adverse reaction monitoring unit is used for monitoring whether an adverse reaction is triggered in the efficacy test and the probability of the adverse reaction, 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 comprises:
the efficacy declaration analysis unit is used for analyzing the human body efficacy test file to obtain a test result of efficacy declaration validity of the cosmetic sample;
and the safety analysis unit is used for analyzing the human body efficacy test file to obtain a test result of declared safety of the efficacy of the cosmetic sample.
In a second aspect, the present invention provides a cosmetic human efficacy test subject management method, which is performed by using the cosmetic human efficacy test subject management system according to the first aspect, and specifically includes the following steps:
(1) a research establishment module is adopted to establish research information for testing the cosmetic human body efficacy test;
(2) screening out the test subjects in the group from the volunteer database by using a test subject screening module according to the research information;
(3) adopting a subject file establishing module to establish a cosmetic human body efficacy test file of each subject, and uploading the cosmetic human body efficacy test file to a data center module;
(4) storing the research information and one or at least two corresponding cosmetic human body efficacy test files by adopting a data center module;
(5) adopting an efficacy test scheme management module, pushing the use information of the cosmetic sample to the subject according to the efficacy test scheme, carrying out an efficacy test to obtain test data of the required subject, and uploading the test data to the 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 an applicant of efficacy test research and related national regulatory agencies 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 supervise the testing process of the cosmetic sample. The subject management module improves the compliance of the subject during the long-term sample efficacy test and improves the accuracy of the efficacy test data. And the efficacy test scheme management module carries out efficient adjustment decision on the efficacy test scheme according to the efficacy test file. The cosmetic human body efficacy test subject management system and method provided by the invention improve the accuracy of cosmetic human body efficacy test data and improve the management efficiency of a research center on cosmetic human body efficacy tests.
Drawings
Fig. 1 is a schematic structural diagram of a cosmetic human efficacy test subject management system according to the present invention.
Detailed Description
The technical scheme of the invention is further explained by the specific implementation mode in combination with the attached drawings. It should be understood by those skilled in the art that the specific embodiments are only for the understanding of the present invention and should not be construed as the specific limitations of the present invention.
Example 1
The present embodiment provides a cosmetic human efficacy test subject management system, as shown in fig. 1, the cosmetic human efficacy test subject management system includes:
the research establishment module 1 is used for establishing research information for testing the cosmetic human body efficacy test;
the subject screening module 2 is connected with the research setting module 1 and is used for screening the grouped subjects from the volunteer database according to the research information;
the subject file establishing module 3 is connected with the research establishing module 1 and the subject screening module 2 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 4 is respectively connected with the research establishment module 1 and the subject file establishment 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 used for pushing the use information of the cosmetic samples to the subjects according to the efficacy test scheme, performing efficacy test to obtain test data of the required subjects and uploading the test data to the efficacy test files in real time;
the adverse reaction monitoring module 6 is connected with the data center module 4 and is used for regularly monitoring the efficacy test data and the adverse reaction data and adjusting the research information and the monitoring and testing data to the human body efficacy test scheme;
the efficacy test scheme management module 7 is connected with the data center module 4 and used for adjusting the human body 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 used for analyzing the human body efficacy test file to obtain cosmetic human body efficacy test data;
and the data sharing module 9 is connected with the data center module 4 and used for providing the human body efficacy test file for an applicant of efficacy test research and related national regulatory agencies in an internet communication mode.
In a preferred embodiment of the invention, the study information includes cosmetic sample information, test objectives, subject inclusion and exclusion criteria.
Specifically in this example, the cosmetic sample information includes: any one of or a combination of at least two of a sample name (trade name registered in the cosmetics registration and docketing test information management system), a sample number, a sample specification, a sample state, a sample package, or a sample provider.
Preferably, the use standard of the cosmetic sample includes any one of or a combination of at least two of a sample use method, a use site, a use frequency, a use period, or a use note.
Preferably, the test purpose includes any one or combination of at least two of cleansing, makeup removal, moisturizing, moisturization, cosmetic modification, hair styling, fragrance, hair care, sun protection, spot removal whitening (physical masking only), wrinkle reduction, firming, repair, soothing, acne removal (including blackhead removal), oil control, cutin removal, body toning (including perspiration), hair coloring, permanent waving, hair loss prevention, hair breakage prevention, dandruff removal, hair color care, hair removal, odor removal, shaving aid, or the like.
Preferably, the subject inclusion criteria include any one or a combination of at least two of age, gender, skin type, compliance, voluntary participation, or other satisfaction of a particular participation condition.
Preferably, the subject exclusion criteria include any one or a combination of at least two of pregnant or lactating women, recent birth plans, skin history, cosmetic and pharmaceutical allergies, participation in other clinical trials in the last trimester, or other clinical assessments not considered appropriate for participation in a trial.
In a preferred embodiment of the present invention, the subject screening module 2 comprises:
the subject screening unit is used for screening a volunteer database according to the research information and screening out undetermined persons meeting the requirements of the subject;
the test unit of the testee is connected with the screening unit of the testee and is used for checking the personnel to be determined and obtaining the baseline data required by the efficacy test of the personnel to be determined;
the subject removing unit is connected with the subject detecting unit and is used for removing the undetermined person which does not accord with the research information according to the falling and replacement principle of the subject;
and the subject grouping unit is connected with the subject detection unit and records the grouping of the subjects.
In the embodiment, particularly, the recruitment time of the subject is greatly shortened through screening of the volunteer database, the screening rate is improved, the period of the human body efficacy test of the cosmetics is shortened on the premise of ensuring the research quality, and the product characteristics of the fast-dissolving cosmetics are better fitted.
In a preferred embodiment of the present invention, the subject profile creating module 3 comprises:
the accepting unit is used for acquiring basic information of each subject according to the volunteer database;
the profiling unit is connected with the receiving unit and is used for establishing an efficacy test file of each subject on the basis of the basic information of the subject, wherein the basic information comprises the personal basic information of the subject and the baseline data of the corresponding subject;
in this example, the subject profile creation module 3 creates information for the human efficacy test profile of each subject, i.e. the subject's information during the complete human efficacy test, including: basic information data, efficacy test data, adverse events, serious adverse events and the like of the testee. The efficacy test data of the subjects during the study will be uploaded in real time to the efficacy test profile of the subjects.
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 manner according to the research information;
the scheme presetting unit is connected with the storage unit and used for generating an initial human body efficacy test research scheme of 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 the 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 this example, the study protocol according to the initial human efficacy test specifically included: test information, test time, test instruments, test environments, test flows, 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 comprises the following steps: test start time and 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 regularly pushing use reminding and use methods of the cosmetic samples to the subjects according to the use standards of the samples in the efficacy test period in an internet communication mode;
the cosmetic sample management unit is used for carrying out sample use management and sample recovery on the testee according to the efficacy test scheme so as to obtain sample use information;
the test subject detection unit is used for regularly or regularly collecting data of the test subjects according to the efficacy research scheme to obtain efficacy test data and uploading the efficacy test data to the efficacy test archive in real time;
in this example, the cosmetic sample usage information pushing unit includes an internet communication mode such as a short message, a WeChat applet, and the like. The test unit of the subject collects data of the subject through research, and obtains human body efficacy test data as evidence for managing the subject.
In a preferred embodiment of the present invention, the adverse reaction monitoring module 6 comprises:
the adverse reaction monitoring unit is used for monitoring whether an adverse reaction is triggered in the efficacy test and the probability of the adverse reaction, 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, the adverse reactions that may occur are detected in a manual detection or internet communication detection manner, and if an adverse reaction occurs, a researcher is reminded to intervene in the treatment of the adverse reaction that may occur, and an efficacy test file is recorded and uploaded in time, so that an efficacy test scheme is adjusted.
In a preferred embodiment of the present invention, the efficacy test plan management module 7 includes:
the data acquisition unit is used for regularly or periodically extracting effective data from the efficacy test file;
and the data analysis unit is connected with the data acquisition unit and is used for analyzing and adjusting the test information by combining the baseline data and the adverse reactions in the efficacy test file.
And the scheme adjusting unit is connected with the data analysis unit and is used for uploading the adjusted efficacy test scheme to the efficacy test file and updating the efficacy test scheme as a replacement 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 declaration analysis unit is used for analyzing the human body efficacy test file to obtain a test result of the efficacy declaration validity of the sample;
and the safety analysis unit is used for analyzing the human body efficacy test file to obtain a test result of the declared safety of the efficacy of the sample.
Specifically, in this example, the efficacy declaration analysis refers to the analysis of the effectiveness index of the efficacy test file by the data analysis module 8 during the execution of the human efficacy test on the cosmetic sample, and the efficacy of the cosmetic human efficacy test scheme is analyzed and evaluated according to the comparison between the effectiveness index and the baseline index. More specifically in this example, the effectiveness indicators include: analysis of moisture content of skin around eyes, analysis of wrinkle area around eyes, and the like.
In this embodiment, the safety analysis specifically refers to the analysis of safety indexes of the efficacy test files by the data analysis module 8 during the execution process of the human efficacy test of the cosmetic samples, and the analysis and evaluation of the safety of the human efficacy test scheme of the cosmetic.
Example 2
The invention provides a cosmetic human body efficacy test subject management method, which is carried out by adopting the cosmetic human body efficacy test subject management system provided by the embodiment 1 and specifically comprises the following steps:
(1) a research establishment module 1 is adopted to design a test research according to the efficacy declaration requirement, and test research information is added into a human body efficacy test subject management system, wherein the research information comprises cosmetic sample information, a test purpose and subject inclusion and exclusion standards;
(2) screening qualified subjects by adopting a subject screening module 2 according to the research information, and checking to establish a baseline;
(3) adopting a subject file establishing module 3 to establish a cosmetic human body efficacy test file of each subject, and uploading the cosmetic human body efficacy test file to a data center module;
(4) the method comprises the following steps of adopting a human body efficacy test file of a data center module 4 to effectively record and supervise the cosmetic sample test process, wherein the human body efficacy test file is established, a human body efficacy test scheme is set, and a human body efficacy test management system carries out testing according to the efficacy test file;
(5) adopting an efficacy test scheme management module, pushing the use information of the cosmetic sample to the subject according to the efficacy test scheme, carrying out an efficacy test to obtain test data of the required subject, and uploading the test data to the 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 an applicant of efficacy test research and related national regulatory agencies in an internet communication mode.
According to the scheme in the embodiment, the accuracy of the human body efficacy test data of the cosmetics is improved, and the management efficiency of the research center on the human body efficacy test of the cosmetics is improved.
The applicant states that the present invention is illustrated by the above examples to describe the cosmetic human efficacy test subject management system and method, but the present invention is not limited to the above examples, i.e., it does not mean that the present invention must rely on the above examples to be implemented. It should be understood by those skilled in the art that any modification of the present invention, equivalent substitutions of the raw materials of the product of the present invention, addition of auxiliary components, selection of specific modes, etc., are within the scope and disclosure of the present invention.
Claims (10)
1. A cosmetic human efficacy test subject management system, comprising:
the research establishment module is used for establishing research information for testing the cosmetic human body efficacy test;
the subject screening module is connected with the research setting module and used for screening the grouped subjects from the volunteer database according to the research information;
the subject file establishing module is connected with the research establishing module and the subject screening module and 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 establishment module and the subject file establishment 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 body 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 used for pushing the use information of the cosmetic samples to the subjects according to the efficacy test scheme, performing efficacy test to obtain test data of the required subjects and uploading the test data to the efficacy test files in real time;
the adverse reaction monitoring module is connected with the data center module and is used for regularly monitoring the efficacy test data and the adverse reaction data and adjusting the research information and the monitoring test data to the human body efficacy test scheme;
the data analysis module is connected with the data center module and used for analyzing the human body efficacy test file to obtain cosmetic human body efficacy test data;
and the data sharing module is connected with the data center module and used for providing the human body efficacy test file to an applicant and a related national regulatory agency of efficacy test research in an internet communication mode.
2. The cosmetic human efficacy test subject management system of claim 1, wherein the research information comprises any one or a combination of at least two of cosmetic sample information, use criteria of cosmetic samples, test purpose, subject inclusion criteria, or subject exclusion criteria;
preferably, the cosmetic sample information includes any one of a sample name, a sample number, a sample specification, a sample status, a sample package, or a sample provider, or a combination of at least two thereof;
preferably, the use standard of the cosmetic sample comprises any one of 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 cleansing, makeup removal, moisturizing, moisturization, cosmetic modification, hair styling, fragrance, hair care, sun protection, spot removal whitening, wrinkle reduction, tightening, repair, soothing, acne removal, oil control, cutin removal, body toning, hair coloring, hair waving, hair loss prevention, hair breakage prevention, dandruff removal, hair color care, hair removal, odor removal, shaving aid, or the like;
preferably, the subject inclusion criteria include any one or combination of at least two of age, gender, skin type, compliance, voluntary participation, or other satisfaction of a particular participation condition;
preferably, the subject exclusion criteria include any one or a combination of at least two of pregnant or lactating women, recent birth plans, skin history, cosmetic and pharmaceutical allergies, participation in other clinical trials in the last trimester, or other clinical assessments not considered appropriate for participation in a trial.
3. The cosmetic human efficacy test subject management system of claim 1 or 2, wherein the subject screening module comprises:
the subject screening unit is used for screening a volunteer database according to the research information and screening out undetermined persons meeting the requirements of the subject;
the test unit of the testee is connected with the screening unit of the testee and is used for checking the personnel to be determined and obtaining the baseline data required by the efficacy test of the personnel to be determined;
the subject removing unit is connected with the subject detecting unit and is used for removing the undetermined person which does not accord with the research information according to the falling and replacement principle of the subject;
and the subject grouping unit is connected with the subject detection unit and records the grouping of the subjects.
4. The cosmetic human efficacy test subject management system according to any one of claims 1 to 3, wherein the subject profile creation module comprises:
the accepting unit is used for acquiring basic information of each subject according to the volunteer database;
and the profiling unit is connected with the receiving unit and establishes an efficacy test file of each subject on the basis of the basic information of the subject, wherein the basic information comprises the personal basic information of the subject and the baseline data of the corresponding subject.
5. The cosmetic human efficacy test subject management system of any one of claims 1-4, wherein the data center module comprises:
the storage unit is used for receiving the efficacy test files and storing the efficacy test files in a classified manner according to the research information;
the scheme presetting unit is connected with the storage unit and used for generating an initial human body efficacy test research scheme of 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 the 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.
6. The cosmetic human efficacy test subject management system according to any one of claims 1 to 5, wherein 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 is used for analyzing and adjusting the test information by combining the baseline data and the adverse reactions in the efficacy test file;
and the scheme adjusting unit is connected with the data analysis unit and is used for uploading the adjusted efficacy test scheme to the efficacy test file and updating the efficacy test scheme as a replacement efficacy test scheme on the basis of keeping the initial efficacy test scheme data.
7. The cosmetic human efficacy test subject management system of any one of claims 1-6, wherein the subject management module comprises:
the cosmetic sample use information pushing unit is used for regularly pushing use reminding and use methods of the cosmetic samples to the subjects according to the use standards of the samples in the efficacy test period in an internet communication mode;
the cosmetic sample management unit is used for carrying out sample use management and sample recovery on the testee according to the efficacy test scheme so as to obtain sample use information;
and the test subject detection unit is used for regularly or periodically collecting data of the test subjects according to the efficacy research scheme to obtain efficacy test data and uploading the efficacy test data to the efficacy test archive in real time.
8. The cosmetic human efficacy test subject management system of any one of claims 1-7, wherein the adverse reaction monitoring module comprises:
the adverse reaction monitoring unit is used for monitoring whether an adverse reaction is triggered in the efficacy test and the probability of the adverse reaction, 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.
9. The cosmetic human efficacy test subject management system of any one of claims 1-8, wherein the data analysis module comprises:
the efficacy declaration analysis unit is used for analyzing the human body efficacy test file to obtain a test result of efficacy declaration validity of the cosmetic sample;
and the safety analysis unit is used for analyzing the human body efficacy test file to obtain a test result of declared safety of the efficacy of the cosmetic sample.
10. A cosmetic human efficacy test subject management method, which is performed by using the cosmetic human efficacy test subject management system according to any one of claims 1 to 9, and specifically comprises the following steps:
(1) a research establishment module is adopted to establish research information for testing the cosmetic human body efficacy test;
(2) screening out the test subjects in the group from the volunteer database by using a test subject screening module according to the research information;
(3) adopting a subject file establishing module to establish a cosmetic human body efficacy test file of each subject, and uploading the cosmetic human body efficacy test file to a data center module;
(4) storing the research information and one or at least two corresponding cosmetic human body efficacy test files by adopting a data center module;
(5) adopting an efficacy test scheme management module, pushing the use information of the cosmetic sample to the subject according to the efficacy test scheme, carrying out an efficacy test to obtain test data of the required subject, and uploading the test data to the 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 an applicant of efficacy test research and related national regulatory agencies in an internet communication mode.
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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 |
-
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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 |
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