CN113889218A - Medicine random management system - Google Patents
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- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
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Abstract
The invention discloses a medicine random management system which comprises a safety module, a scheme building module, a scheme information viewing module, a center management module, a subject management module, a medicine management module, a report management module and a process control module, wherein the safety module provides a login system for a user, the login system has limited timeliness, and an account password has safety protection measures; the scheme building module comprises the creation of basic information, design rules and definition; the scheme information viewing module is used for viewing clinical information, medicine information and central randomization; the central management module is used for setting warning for the medicines, checking the receiving condition and checking a central list; the subject management module is used for carrying out random management and blind uncovering management on the subjects; the drug management module is used for managing drug inventory and states; the report management module provides downloading of the report; the process control module is used for checking all data tracks in the system.
Description
Technical Field
The invention relates to the technical field of management systems, in particular to a medicine random management system.
Background
Clinical tests refer to clinical studies for finding a better treatment mode by comparing with a certain existing treatment mode or scheme, but the existing clinical test management system cannot timely know and control the progress and information of the whole medical clinical test, the dispensing and drug inventory of a subject cannot be known in real time, and the test results are affected by various uncertain factors in the clinical test process of the subject, so that errors are caused.
Disclosure of Invention
The present invention is directed to a medication randomization management system, which solves the problems set forth in the background art.
In order to solve the technical problems, the invention provides the following technical scheme: a medicine random management system is characterized by comprising a security module, a scheme building module, a scheme information checking module, a central management module and a subject management module; the safety module is used for ensuring the safety of user account login; the scheme building module is used for building basic information and rules of the medicine random management system; the scheme information checking module is used for checking all information of the medicine random management system; the central management module is used for managing the medicines in the medicine random management system; the subject management module is used for managing the subjects in the drug random management system.
Furthermore, the safety module comprises an account login unit and a login aging control unit, wherein the account login unit is used for a user to login and provide a login system, and the user performs login operation through an account number and a password; the login time effectiveness control unit is used for controlling the login time of a user and the time effectiveness of a login password, and comprises the following specific steps:
step a: the login time-effect unit sets the password effective time limit as T and records the time for changing the password for the ith time as TiIf the password time is changed for the (i + 1) th time, the password time is Ti+1；
Step b: judging whether the password is overdue or not when the login time-effect unit logs in, and if T, judging whether the password is overdue or noti+1-TiIf the password is more than or equal to T, the login aging unit prompts that the current password is overdue and the password needs to be reset; if Ti+1-TiIf the password is less than T, the password is in the validity period, and normal login is carried out;
step c: after the login is finished, the login aging unit sets the effective login time to be S minutes according to the system;
step d: the logging aging unit judges whether the system is operated on an interface within S minutes;
step e: the login aging unit judges that the interface is not operated, and then login needs to be carried out again; and if the interface is judged to be operated, the operation is normally carried out.
Further, the scheme building module comprises a scheme building unit, a random scheme setting unit, an external connection unit, a blind bottom leading-in unit and a random mode setting unit;
the scheme creating unit is used for creating scheme information in the medicine random management system, newly creating a project scheme in the system, and completing filling of corresponding basic information of the project scheme according to the project scheme;
the random scheme setting unit is used for setting a random basic rule and a random grouping definition, the random basic rule comprises a sample size, a medicine name, a medicine type, a rule applying a blind method, a random mode and a grouping mode, the random grouping definition comprises a grouping type, a group name, a grouping proportion and an inter-group maximum example number difference, and the inter-group maximum example number difference is judged according to the grouping proportion;
the external connection unit is provided with an EDC system, a contact mailbox and an unvoiced operating system, wherein the EDC system is an electronic data capture system and is platform software for clinical test data acquisition and transmission;
the external connection unit is used for supporting randomized reminding, the external connection unit carries out reminding setting on the blind uncovering operation system through a contact mailbox, the external connection unit carries out interface butt joint through an EDC system, the EDC system is used for acquiring a random number, random time and a medicine number, the blind uncovering operation system is used for carrying out blind uncovering operation, and the contact mailbox is used for establishing contact between the external connection unit and the blind uncovering operation system;
the blind bottom introduction unit is used for initial introduction and multiple introduction of the blind bottom, the blind bottom introduction unit is provided with random blind bottom introduction and medicine number introduction, and one blind bottom can correspond to a plurality of medicine numbers;
the random mode setting unit is provided with three random modes, namely block random, hierarchical random and dynamic random, wherein the block random comprises central competition group random and central quota group random; the central competition grouping zone group random and the central quota grouping zone group random are used for realizing the maximum randomization of the items; stratified randomization was used to perform block randomization on subjects in stratification; dynamic randomization dynamic calculation of the blind bottom was achieved using a minimization randomization method, which was used to balance the relationship between the maximum randomization of the project and the drug number of the subject.
Further, the scheme information viewing module comprises a clinical information viewing unit, a centralized random viewing unit and a medicine information viewing unit;
the clinical information checking unit is used for checking the detailed information of the clinical test, and the detailed information of the clinical test comprises basic information, random information and grouping information of the test; the basic information comprises the whole course of the project, the project scheme number, the version number, the indication and the planned grouping number; the random information comprises sample size, drug type, drug name, blindness, random mode and grouping mode; the grouping information comprises grouping types, group names, grouping proportions and maximum proportion difference among groups;
the central randomization viewing unit is used for viewing basic information of the central randomization, and the basic information of the central randomization includes a group entry total number, a random number, an emergency blind uncovering number, a single blind uncovering number, a blind breaking rate, a random number of each center, a blind breaking number and a random proportion of each center;
the medicine information viewing unit is used for viewing the existing medicines in the warehouse, the existing medicines in each center, the total number of the waste medicines, various states and failure rates of the medicines in each center.
Further, the central management module comprises a drug alert setting unit, a central list viewing unit and a drug receiving unit;
the drug alert setting unit is used for performing alert setting on the real-time inventory of drugs;
the central list viewing unit is used for viewing a central list, displaying different random modes according to the grouping mode in the random scheme setting unit to acquire a group number and add the group number, and the central list is used for displaying a central name and the group number;
the drug receiving unit is used for receiving drugs in batches and managing the received drugs, and the drugs in the drug receiving unit comprise drugs in transportation, drugs in a 'perfect dispensable' state and drugs in a 'lost, over-temperature, damaged, over-term and invalid' state; the method comprises the steps of receiving the medicines in transportation in batches, filling the names of the changers in the medicines in the 'perfect dispensable' state, and inputting the change reasons and filling the names of the changers in the medicines in the 'lost, over-temperature, damaged, overdue and invalid' states.
Further, the subject management module comprises a subject creating unit, a subject signal conducting unit, a subject random management unit and a subject blind uncovering management unit; the subject management module is provided with an IWRS system and a CRF table;
the IWRS system is a central stochastic system, is a computer information system used for services such as random distribution, subject management, drug management and the like in clinical trials, is an interactive technical system, and is also a central stochastic system based on a network; the CRF table is a case report table in clinical trials, which is a file specified according to a trial scheme and used for recording data of each subject in the trial process, and the completeness, the accuracy and the quality of clinical trial data collection are all related to the case report table.
The subject creating unit is used for creating basic information of the subject and viewing and managing the basic information of the subject, the subject is created to comprise a research center, a name abbreviation and a screening number, and when the basic information of the subject is viewed by the subject creating unit, the subject creating unit can edit and modify the basic information of the created subject;
the test subject signal conduction unit is used for docking a test subject with the EDC system, acquiring a random number, random time and a drug number;
the subject random management unit is used for performing random management on the subject and comprises a random operation and a random medicine taking operation;
the examinee blind uncovering management unit is used for carrying out blind uncovering management on the examinee and comprises conventional blind uncovering, emergency blind uncovering and batch blind uncovering;
conventional uncovering is that single case uncovering is carried out, the uncovering reason and the uncovering person are input, and the information of the current subject is confirmed again; after confirming the blind uncovering, the researcher completes the electronic signature on line; after the blind uncovering is finished, the group, the blind uncovering person and the blind uncovering time of the current subject can be checked;
the emergent blind uncovering is to input the blind uncovering reason and the blind uncovering, and to confirm the information of the current subject again; after confirming the blind uncovering, the researcher completes the electronic signature on line; after the blind uncovering is finished, the group, the blind uncovering person and the blind uncovering time of the current subject can be checked;
batch blind uncovering is to input the blind uncovering type, the blind uncovering reason and the blind uncovering, confirm the information of the subject again, after confirming the blind uncovering, the researcher completes the electronic signature on line, and after the blind uncovering is completed, the group, the blind uncovering person and the blind uncovering time of the subject can be checked.
Further, the drug alert setting unit sets the alert of the drug, and the specific process is as follows:
step o: the system sets the maximum stock of the central medicines as G, the central warning threshold value as P, the floating proportion of the maximum stock as X, and the real-time stock as XjJ is not less than 1 and j represents the jth day;
step p: when x is larger than or equal to P, the system automatically sends a medicine number list to be sent, and the medicine number list is sent by a warehouse;
step r: calculating the difference value of the stock in any two adjacent days in seven days to be (x)2-x1)、(x3-x2)、(x4-x3)、(x5-x4)、(x6-x5)、(x7-x6)；
Step s: respectively calculate
A value of (d);
step t: taking the maximum value in the step s as Xmax，
Step u: comparison of XmaxAnd the size of X when X ismaxAnd when the number is more than or equal to X, sending alarm information.
Further, the maximum percentage difference between groups is judged according to the grouping proportion, and the specific process is as follows:
step f: setting the maximum error value as A, and the random scheme setting unit judges the difference between the most numerous groups and the lowest group as A1；
Step g: if A1>A, the random scheme setting unit preferentially takes the block group with the least number if A1Normally grouping the groups when the number is less than or equal to A;
the method comprises the following specific steps of randomly dividing a central competition group entering area group:
step h: randomly importing blind bases and medicine numbers into a central competition group entering area group, wherein one blind base can correspond to a plurality of medicine numbers;
step q: the subject completes the coding according to the arrangement sequence of the blind bottom;
step k: the drug number of the subject obtains the corresponding number according to the sequence of introducing the drugs;
the method comprises the following specific steps of randomly dividing a central quota grouping area group:
step l: randomly importing blind bases and medicine numbers into the central quota grouping area group, wherein one blind base can correspond to a plurality of medicine numbers;
step m: the subject completes coding in turn in the random code of the block group existing in the center;
step n: the drug number of the subject acquires the corresponding number according to the order of introducing the drugs.
Further, the subject management module is provided with an IWRS system and a CRF case report table, and the acquisition process of the random number, the random time and the drug number is as follows:
the method comprises the following steps: the test subject signal transmission unit is in butt joint with the EDC system, and automatically pushes test subject information to the IWRS system;
step two: acquiring a random number and random time from a CRF case report table, automatically completing randomization by an IWRS system, returning the random number and the random time to an EDC system, and transmitting a returned conclusion to the IWRS system;
step three: acquiring a 'drug number' request from a CRF case report table, sending the request to an IWRS system, returning the 'drug number' to an EDC system, and returning a returned conclusion to the IWRS system;
step IV: when the drug is dispensed to the subject, the drug status will synchronously turn to "released";
the subject random management unit comprises a random operation and a random medicine taking operation, and is operated by a researcher, and the specific operation process is as follows:
step 1: the researcher clicks a 'random' button to obtain a random number of the subject;
step 2: when the 'random' button automatically changes into 'random medicine taking', the state changes into a blind state;
and step 3: the researcher clicks the button of 'randomly getting the medicine', and the button of 'randomly getting the medicine' is still displayed after the test subject obtains the serial number of getting the medicine, so that the 'randomly getting the medicine' is supported for a plurality of times;
and 4, step 4: the warehouse drug status automatically translates to "dispensed".
Further, the medicine random management system comprises a medicine management module, a report management module and a process control module; the drug management module is used for managing drug inventory and drug states; the report flat management module provides downloading of the report; the process control module is used for checking all data tracks in the system.
Further, the drug management module comprises an item drug inventory management unit and a drug state tracking unit;
the project medicine inventory management unit manages the inventory of project medicines, including managing medicine numbers, medicine types, generation dates, expiration dates, dosages and dosage forms; the project medicine inventory management unit can check the details of medicines, including medicine numbers, medicine types, generation dates, expiration dates, doses, medicine states, state change reasons, operators and operation time, and firstly uploads medicine documents and leads in the medicines in batches; then, a certain medicine is selected to be sent to the center in a medicine management mode of minimum distribution dosage, and the state of the sent medicine is 'in transit';
the drug state tracking unit is used for reminding drug delivery and tracking the drug state in the whole process, and firstly, after the central management module triggers drug warning, warehouse management personnel receive information reminding of drug delivery and drug delivery; secondly, the central management module checks a central medicine list, tracks the use condition of the medicine, and only the medicine which can be completely dispensed can be used for the testee; thirdly, after the subject obtains the medicine, the state is changed into 'released'; finally, if the drug abnormal condition occurs in the drug management process, the drug state can be changed and the reason can be explained, and the batch drug state change is supported.
Further, the report management module comprises a report downloading unit; the report downloading unit supports the downloading of reports, supports the blind bottom export without uncovering and after uncovering, and downloads the reports in an Excel form; random blind bottom derivation is supported, and downloading is carried out in a PDF form.
Further, the process control module comprises a data track checking unit; the data track inspection unit inspects the track of the data change in the whole process, and the data change generated in the operation process of the system leaves traces in the operations such as blind bottom introduction, blind uncovering, batch blind uncovering, new subject creation, subject deletion, random medicine taking and the like.
Compared with the prior art, the invention has the following beneficial effects: the invention realizes the real-time understanding of the states of the testees and the drugs in the system, the mastering of the progress and the information of the whole clinical medical test and the feasibility of multi-user operation, and can better reduce the error of uncertain factors on the test result by utilizing various random modes.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention. In the drawings:
FIG. 1 is a schematic diagram of a medication administration system according to the present invention;
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Referring to fig. 1, the present invention provides a technical solution: a medicine random management system is characterized by comprising a security module, a scheme building module, a scheme information checking module, a central management module and a subject management module; the safety module is used for ensuring the safety of user account login; the scheme building module is used for building basic information and rules of the medicine random management system; the scheme information checking module is used for checking all information of the medicine random management system; the central management module is used for managing the medicines in the medicine random management system; the subject management module is used for managing the subjects in the drug random management system.
The safety module comprises an account login unit and a login aging control unit, wherein the account login unit is used for a user to login and provide a login system, and the user performs login operation through an account number and a password; the login time effectiveness control unit is used for controlling the login time of a user and the time effectiveness of a login password, and comprises the following specific steps:
step a: the login time-effect unit sets the password effective time limit as T and records the time for changing the password for the ith time as TiIf the password time is changed for the (i + 1) th time, the password time is Ti+1；
Step b: judging whether the password is overdue or not when the login time-effect unit logs in, and if T, judging whether the password is overdue or noti+1-TiIf the password is more than or equal to T, the login aging unit prompts that the current password is overdue and the password needs to be reset; if Ti+1-TiIf the password is less than T, the password is in the validity period, and normal login is carried out;
step c: after the login is finished, the login aging unit sets the effective login time to be S minutes according to the system;
step d: the logging aging unit judges whether the system is operated on an interface within S minutes;
step e: the login aging unit judges that the interface is not operated, and then login needs to be carried out again; and if the interface is judged to be operated, the operation is normally carried out.
The login aging unit is provided with the password validity period and interface protection, so that the information leakage risk caused by long-time non-operation on the computer is effectively avoided, and the safety problem of the password validity period is improved.
The scheme building module comprises a scheme building unit, a random scheme setting unit, an external connection unit, a blind bottom leading-in unit and a random mode setting unit;
the scheme creating unit is used for creating scheme information in the medicine random management system, newly creating a project scheme in the system, and completing filling of corresponding basic information of the project scheme according to the project scheme;
the random scheme setting unit is used for setting a random basic rule and a random grouping definition, the random basic rule comprises a sample size, a medicine name, a medicine type, a rule applying a blind method, a random mode and a grouping mode, the random grouping definition comprises a grouping type, a group name, a grouping proportion and an inter-group maximum example number difference, and the inter-group maximum example number difference is judged according to the grouping proportion;
the external connection unit is provided with an EDC system, a contact mailbox and an unvoiced operating system, wherein the EDC system is an electronic data capture system and is platform software for clinical test data acquisition and transmission;
the external connection unit is used for supporting randomized reminding, the external connection unit carries out reminding setting on the blind uncovering operation system through a contact mailbox, the external connection unit carries out interface butt joint through an EDC system, the EDC system is used for acquiring a random number, random time and a medicine number, the blind uncovering operation system is used for carrying out blind uncovering operation, and the contact mailbox is used for establishing contact between the external connection unit and the blind uncovering operation system;
the blind bottom introduction unit is used for initial introduction and multiple introduction of the blind bottom, the blind bottom introduction unit is provided with random blind bottom introduction and medicine number introduction, and one blind bottom can correspond to a plurality of medicine numbers;
the random mode setting unit is provided with three random modes, namely block random, hierarchical random and dynamic random, wherein the block random comprises central competition group random and central quota group random; the central competition grouping zone group random and the central quota grouping zone group random are used for realizing the maximum randomization of the items; stratified randomization was used to perform block randomization on subjects in stratification; dynamic randomization dynamic calculation of the blind bottom was achieved using a minimization randomization method, which was used to balance the relationship between the maximum randomization of the project and the drug number of the subject.
The whole system scheme has been built to the module is built to the scheme, concreties medicine system, test scheme and with external signal transmission's connected system, and the scheme is built and is carried out newly-built of testee after the module is built to the scheme is accomplished, carries out the scheme setting after the new completion of testee, and the scheme setting is further accomplished and is carried out the random management setting for the frame of system is more clear and concrete, also more makes things convenient for the researcher to operate.
The scheme information checking module comprises a clinical information checking unit, a centralized random checking unit and a medicine information checking unit;
the clinical information checking unit is used for checking the detailed information of the clinical test, and the detailed information of the clinical test comprises basic information, random information and grouping information of the test; the basic information comprises the whole course of the project, the project scheme number, the version number, the indication and the planned grouping number; the random information comprises sample size, drug type, drug name, blindness, random mode and grouping mode; the grouping information comprises grouping types, group names, grouping proportions and maximum proportion difference among groups;
the central randomization viewing unit is used for viewing basic information of the central randomization, and the basic information of the central randomization includes a group entry total number, a random number, an emergency blind uncovering number, a single blind uncovering number, a blind breaking rate, a random number of each center, a blind breaking number and a random proportion of each center;
the medicine information viewing unit is used for viewing the existing medicines in the warehouse, the existing medicines in each center, the total number of the waste medicines, various states and failure rates of the medicines in each center.
The scheme information module is arranged to plan all classified information in the system to the clinical information checking unit, the central randomized checking unit and the drug information checking unit for checking the system, so that the efficiency of searching the information in a large range is effectively saved.
The central management module comprises a drug alert setting unit, a central list viewing unit and a drug receiving unit;
the drug alert setting unit is used for performing alert setting on the real-time inventory of drugs;
the central list viewing unit is used for viewing a central list, displaying different random modes according to the grouping mode in the random scheme setting unit to acquire a group number and add the group number, and the central list is used for displaying a central name and the group number;
the drug receiving unit is used for receiving drugs in batches and managing the received drugs, and the drugs in the drug receiving unit comprise drugs in transportation, drugs in a 'perfect dispensable' state and drugs in a 'lost, over-temperature, damaged, over-term and invalid' state; the method comprises the steps of receiving the medicines in transportation in batches, filling the names of the changers in the medicines in the 'perfect dispensable' state, and inputting the change reasons and filling the names of the changers in the medicines in the 'lost, over-temperature, damaged, overdue and invalid' states.
The central management module is arranged, so that a main researcher can check the central list more conveniently, and the group number in the central list checking unit can enable the researcher to quickly inquire the group information of the subject; for the arrangement of the drug warning and drug receiving unit, the central drug manager can conveniently pre-judge the drugs and analyze the conditions; the central management module is set up to independently, clearly and clearly control the main part of the system.
The subject management module comprises a subject creating unit, a subject signal conducting unit, a subject random management unit and a subject blindness uncovering management unit; the subject management module is provided with an IWRS system and a CRF table;
the IWRS system is a central stochastic system, is a computer information system used for services such as random distribution, subject management, drug management and the like in clinical trials, is an interactive technical system, and is also a central stochastic system based on a network; the CRF table is a case report table in clinical trials, which is a file specified according to a trial scheme and used for recording data of each subject in the trial process, and the completeness, the accuracy and the quality of clinical trial data collection are all related to the case report table.
The subject creating unit is used for creating basic information of the subject and viewing and managing the basic information of the subject, the subject is created to comprise a research center, a name abbreviation and a screening number, and when the basic information of the subject is viewed by the subject creating unit, the subject creating unit can edit and modify the basic information of the created subject;
the test subject signal conduction unit is used for docking a test subject with the EDC system, acquiring a random number, random time and a drug number;
the subject random management unit is used for performing random management on the subject and comprises a random operation and a random medicine taking operation;
the examinee blind uncovering management unit is used for carrying out blind uncovering management on the examinee and comprises conventional blind uncovering, emergency blind uncovering and batch blind uncovering;
conventional uncovering is that single case uncovering is carried out, the uncovering reason and the uncovering person are input, and the information of the current subject is confirmed again; after confirming the blind uncovering, the researcher completes the electronic signature on line; after the blind uncovering is finished, the group, the blind uncovering person and the blind uncovering time of the current subject can be checked;
the emergent blind uncovering is to input the blind uncovering reason and the blind uncovering, and to confirm the information of the current subject again; after confirming the blind uncovering, the researcher completes the electronic signature on line; after the blind uncovering is finished, the group, the blind uncovering person and the blind uncovering time of the current subject can be checked;
batch blind uncovering is to input the blind uncovering type, the blind uncovering reason and the blind uncovering, confirm the information of the subject again, after confirming the blind uncovering, the researcher completes the electronic signature on line, and after the blind uncovering is completed, the group, the blind uncovering person and the blind uncovering time of the subject can be checked.
The drug alert setting unit performs alert setting on the drug, and the specific process is as follows:
step o: system set-up central drug maximum inventoryThe quantity is G, the central warning threshold value is P, the maximum stock floating proportion is X, and the real-time stock is XjJ is not less than 1 and j represents the jth day;
step p: when x is larger than or equal to P, the system automatically sends a medicine number list to be sent, and the medicine number list is sent by a warehouse;
step r: calculating the difference value of the stock in any two adjacent days in seven days to be (x)2-x1)、(x3-x2)、(x4-x3)、(x5-x4)、(x6-x5)、(x7-x6)；
Step s: respectively calculate
A value of (d);
step t: taking the maximum value in the step s as Xmax，
Step u: comparison of XmaxAnd the size of X when X ismaxAnd when the number is more than or equal to X, sending alarm information.
The arrangement of the medicine warning unit ensures the implementation and supply of medicine inventory, and under special conditions, the shortage of medicines and the sudden medicine proportion floating problem give timely response, warning calculation carried out every day provides guarantee for central medicine managers under the normal circulation of medicines, the difference condition of every two adjacent days and the maximum inventory ratio calculation of the central medicines are used, the medicine inventory condition of every day can be obtained, evaluation can be carried out every other week, and effective feedback and monitoring are brought to the medicine management module.
The maximum example number difference between groups is judged according to the grouping proportion, and the specific process is as follows:
step f: setting the maximum error value as A, and the random scheme setting unit judges the difference between the most numerous groups and the lowest group as A1；
Step g: if A1>A, the random scheme setting unit preferentially takes the block group with the least number if A1Normally grouping the groups when the number is less than or equal to A;
the method comprises the following specific steps of randomly dividing a central competition group entering area group:
step h: randomly importing blind bases and medicine numbers into a central competition group entering area group, wherein one blind base can correspond to a plurality of medicine numbers;
step q: the subject completes the coding according to the arrangement sequence of the blind bottom;
step k: the drug number of the subject obtains the corresponding number according to the sequence of introducing the drugs;
the method comprises the following specific steps of randomly dividing a central quota grouping area group:
step l: randomly importing blind bases and medicine numbers into the central quota grouping area group, wherein one blind base can correspond to a plurality of medicine numbers;
step m: the subject completes coding in turn in the random code of the block group existing in the center;
step n: the drug number of the subject acquires the corresponding number according to the order of introducing the drugs.
The test subject management module sets an IWRS system and a CRF case report table, and the acquisition process of random numbers, random time and drug numbers is as follows:
the method comprises the following steps: the test subject signal transmission unit is in butt joint with the EDC system, and automatically pushes test subject information to the IWRS system;
step two: acquiring a random number and random time from a CRF case report table, automatically completing randomization by an IWRS system, returning the random number and the random time to an EDC system, and transmitting a returned conclusion to the IWRS system;
step three: acquiring a 'drug number' request from a CRF case report table, sending the request to an IWRS system, returning the 'drug number' to an EDC system, and returning a returned conclusion to the IWRS system;
step IV: when the drug is dispensed to the subject, the drug status will synchronously turn to "released";
the subject random management unit comprises a random operation and a random medicine taking operation, and is operated by a researcher, and the specific operation process is as follows:
step 1: the researcher clicks a 'random' button to obtain a random number of the subject;
step 2: when the 'random' button automatically changes into 'random medicine taking', the state changes into a blind state;
and step 3: the researcher clicks the button of 'randomly getting the medicine', and the button of 'randomly getting the medicine' is still displayed after the test subject obtains the serial number of getting the medicine, so that the 'randomly getting the medicine' is supported for a plurality of times;
and 4, step 4: the warehouse drug status automatically translates to "dispensed".
The arrangement of the subject management module enables the system to be based on the existing mature IWRS system, management of the subject is randomized by combining a case report table, the subject management module performs three blind uncovering operations on the subject random management unit on the basis of the scheme building module, the possibility of the subject under different conditions of clinical tests is increased by the three different blind uncovering operations, the subject management module enables the performance results of the subject to be more random, and the accuracy of the clinical test results is higher.
A medicine random management system comprises a medicine management module, a report management module and a process management and control module; the drug management module is used for managing drug inventory and drug states; the report flat management module provides downloading of the report; the process control module is used for checking all data tracks in the system.
The drug management module comprises an item drug inventory management unit and a drug state tracking unit;
the project medicine inventory management unit manages the inventory of project medicines, including managing medicine numbers, medicine types, generation dates, expiration dates, dosages and dosage forms; the project medicine inventory management unit can check the details of medicines, including medicine numbers, medicine types, generation dates, expiration dates, doses, medicine states, state change reasons, operators and operation time, and firstly uploads medicine documents and leads in the medicines in batches; then, a certain medicine is selected to be sent to the center in a medicine management mode of minimum distribution dosage, and the state of the sent medicine is 'in transit';
the drug state tracking unit is used for reminding drug delivery and tracking the drug state in the whole process, and firstly, after the central management module triggers drug warning, warehouse management personnel receive information reminding of drug delivery and drug delivery; secondly, the central management module checks a central medicine list, tracks the use condition of the medicine, and only the medicine which can be completely dispensed can be used for the testee; thirdly, after the subject obtains the medicine, the state is changed into 'released'; finally, if the drug abnormal condition occurs in the drug management process, the drug state can be changed and the reason can be explained, and the batch drug state change is supported.
The drug management module is used for detailing the state and the heading of each drug, so that a researcher can accurately master the drug information and the feedback of a subject on the drugs; and for the information of the central medicine manager based on the central management module, the medicine safety problems of various states in the warehouse are reasonably controlled.
The report management module comprises a report downloading unit; the report downloading unit supports the downloading of reports, supports the blind bottom export without uncovering and after uncovering, and downloads the reports in an Excel form; random blind bottom export is supported, the report management module is downloaded in a PDF form, so that the report management module is convenient for a subject and a researcher to download according to the requirement, and the report management module is convenient to reserve.
The process control module comprises a data track checking unit; the data track inspection unit inspects the track of the data change in the whole process, and the data change generated in the operation process of the system leaves traces in the operations such as introduction of blind bottoms, blind uncovering, batch blind uncovering, new creation of testees, deletion of the testees, random medicine taking and the like; the application of the process control module enables researchers to inquire required data at any stage, and the inquiry of the system is convenient and fast.
It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
Finally, it should be noted that: although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that changes may be made in the embodiments and/or equivalents thereof without departing from the spirit and scope of the invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (9)
1. A medicine random management system is characterized by comprising a security module, a scheme building module, a scheme information checking module, a central management module and a subject management module; the safety module is used for ensuring the safety of user account login; the scheme building module is used for building basic information and rules of the medicine random management system; the scheme information checking module is used for checking all information of the medicine random management system; the central management module is used for managing the medicines in the medicine random management system; the subject management module is used for managing the subjects in the drug randomisation management system.
2. The system according to claim 1, wherein: the safety module comprises a login aging control unit, the login aging control unit is used for controlling login duration and login password aging of a user, and the safety module specifically comprises the following steps:
step a: the login aging unit sets the password valid time limit to be T and records the ith password changing time to be TiIf the password time is changed for the (i + 1) th time, the password time is Ti+1；
Step b: judging whether the password is overdue or not when the login aging unit logs in, and if T, judging whether the password is overdue or noti+1-TiIf the password is more than or equal to T, the login aging unit prompts that the current password is overdue and the password needs to be reset; if Ti+1-TiIf the password is less than T, the password is in the validity period, and normal login is carried out;
step c: after the login is finished, the login aging unit sets the effective login time to be S minutes according to the system;
step d: the login aging unit judges whether the system is operated on an interface within S minutes;
step e: the login aging unit judges that the interface is not operated, and then login needs to be carried out again; and if the interface is judged to be operated, the operation is normally carried out.
3. The system according to claim 1, wherein: the scheme building module comprises a scheme creating unit, a random scheme setting unit, an external connection unit, a blind bottom leading-in unit and a random mode setting unit;
the scheme creating unit is used for creating scheme information in the medicine random management system, newly creating a project scheme in the system, and completing filling of basic information corresponding to the project scheme according to the project scheme;
the random scheme setting unit is used for setting a random basic rule and a random grouping definition, the random basic rule comprises a sample size, a medicine name, a medicine type, a rule of applying a blind method, a random mode and a grouping mode, the random grouping definition comprises a grouping type, a group name, a grouping proportion and an inter-group maximum example number difference, and the inter-group maximum example number difference is judged according to the grouping proportion;
the external connection unit is provided with an EDC system, a contact mailbox and an uncovering operation system, the external connection unit is used for supporting randomized reminding, the external connection unit carries out reminding setting on the uncovering operation system through the contact mailbox, and the external connection unit carries out interface butt joint through the EDC system, wherein the EDC system is used for acquiring a random number, random time and a medicine number, the uncovering operation system is used for carrying out uncovering operation, and the contact mailbox is used for establishing contact between the external connection unit and the uncovering operation system;
the blind bottom introduction unit is used for initial introduction and multiple introduction of the blind bottom, the blind bottom introduction unit is provided with random blind bottom introduction and medicine number introduction, and one blind bottom can correspond to a plurality of medicine numbers;
the random mode setting unit is provided with three random modes, wherein the three random modes are block random, layered random and dynamic random, and the block random comprises central competition group random and central quota group random; the central contention grouping zone group randomization and the central quota grouping zone group randomization are used for realizing the maximum randomization of the items; the stratified randomization is used to perform block randomization on the subjects in stratification; the dynamic randomization uses a minimization of randomization method to achieve a dynamic calculation of the blind bottom, which is used to balance the relationship between the maximum randomization of the project and the drug number of the subject.
4. The system according to claim 1, wherein: the scheme information checking module comprises a clinical information checking unit, a centralized random checking unit and a medicine information checking unit;
the clinical information checking unit is used for checking detailed information of a clinical test, and the detailed information of the clinical test comprises basic information, random information and grouping information of the test; the basic information comprises the whole course of the project, the project scheme number, the version number, the indication and the planned grouping number; the random information comprises sample size, drug type, drug name, blindness, random mode and grouping mode; the grouping information comprises grouping types, group names, grouping proportions and maximum proportion difference among groups;
the central randomization viewing unit is used for viewing basic information of a central randomization condition, wherein the basic information of the central randomization condition comprises a group entry total number, a random number, an emergency blind uncovering number, a single-case blind uncovering number, a blind breaking rate, a random number of each center, a blind breaking number and a random occupation ratio of each center;
the medicine information viewing unit is used for viewing the existing medicines in the warehouse, the existing medicines in each center, the total number of the waste medicines, various states and failure rates of the medicines in each center.
5. A medication randomization system in accordance with claim 3, wherein: the central management module comprises a drug alert setting unit, a central list viewing unit and a drug receiving unit;
the drug alert setting unit is used for performing alert setting on the real-time inventory of the drugs;
the central list viewing unit is used for viewing a central list, displaying different random patterns according to the grouping mode in the random scheme setting unit to acquire a group number and add the group number, and the central list is used for displaying a central name and the group number;
the drug receiving unit is used for receiving drugs in batches and managing the received drugs, and the drugs of the drug receiving unit comprise drugs in transportation, drugs in a 'perfect dispensable' state and drugs in a 'lost, over-temperature, damaged, over-term and invalid' state; the method comprises the steps that batch receiving operation is carried out on the medicines in transportation, the names of the changers need to be filled in the medicines in the 'perfect dispensable' state, and the names of the changers need to be input and filled in the medicines in the 'lost, over-temperature, damaged, over-term and invalid' states.
6. A medication randomization system in accordance with claim 3, wherein: the subject management module comprises a subject creating unit, a subject signal conducting unit, a subject random management unit and a subject blind uncovering management unit; the subject management module is provided with an IWRS system and a CRF table;
the subject creating unit is used for creating basic information of a subject and the subject, and viewing and managing the basic information of the subject, the created subject comprises a research center, a name abbreviation and a screening number, and when the subject creating unit views the basic information of the subject, the subject creating unit can edit and modify the basic information of the created subject;
the subject signaling unit is used for interfacing a subject with the EDC system, acquiring a random number, a random time and a drug number;
the subject random management unit is used for performing random management on the subject and comprises a random operation and a random medicine taking operation;
the examinee blind uncovering management unit is used for carrying out blind uncovering management on the examinee and comprises conventional blind uncovering, emergency blind uncovering and batch blind uncovering.
7. The system according to claim 5, wherein: the drug alert setting unit performs alert setting on the drug, and the specific process is as follows:
step o: the system sets the maximum inventory of the central medicines as G, the central warning threshold value as P, the floating proportion of the maximum inventory as X, and the real-time inventory as XjJ is not less than 1 and j represents the jth day;
step p: when x is larger than or equal to P, the system automatically sends a medicine number list to be sent, and the medicine number list is sent by a warehouse;
step r: calculating the difference value of the stock in any two adjacent days in seven days to be (x)2-x1)、(x3-x2)、(x4-x3)、(x5-x4)、(x6-x5)、(x7-x6)；
Step s: respectively calculate
A value of (d);
step t: taking the maximum value in the step s as Xmax，
Step u: comparison of XmaxAnd the size of X when X ismaxAnd when the number is more than or equal to X, sending alarm information.
8. A medication randomization system in accordance with claim 3, wherein: the maximum example number difference between the groups is judged according to the grouping proportion, and the specific process is as follows:
step f: setting the maximum error value to A, and the random scheme setting unit judges the difference between the most numerous groups and the lowest group to A1；
Step g: if A1>A, the random scheme setting unit preferentially takes the block with the least number if A1Normally grouping the groups when the number is less than or equal to A;
the central competition group entering area group is randomly divided, and the specific process is as follows:
step h: the central competition group entering area group randomly introduces blind bases and medicine numbers, and one blind base can correspond to a plurality of medicine numbers;
step q: the subject completes coding according to the arrangement sequence of the blind bottom;
step k: the drug number of the subject obtains a corresponding number according to the sequence of introducing the drugs;
the central quota grouping area group is randomly divided, and the specific process is as follows:
step l: the central quota grouping area group randomly introduces blind bottoms and medicine numbers, and one blind bottom can correspond to a plurality of medicine numbers;
step m: the subjects complete coding in turn in the block random code existing in the center;
step n: the drug number of the subject acquires the corresponding number according to the sequence of introducing the drugs.
9. The system according to claim 6, wherein: the subject management module is provided with an IWRS system and a CRF table, and the acquisition process of the random number, the random time and the drug number is as follows:
the method comprises the following steps: the subject signaling unit interfaces with an EDC system, the subject signaling unit automatically pushing subject information to the IWRS system;
step two: acquiring a random number and random time from the CRF table, automatically completing randomization by the IWRS system, returning the random number and the random time to the EDC system, and transmitting a returned conclusion to the IWRS system;
step three: acquiring a 'drug number' request from the CRF table, sending the request to the IWRS system, returning the 'drug number' to the EDC system, and returning a returned conclusion to the IWRS system;
step IV: when the drug is dispensed to the subject, the drug state will synchronously turn to "released".
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