CN112712862A

CN112712862A - Method, device and system for generating clinical research time schedule

Info

Publication number: CN112712862A
Application number: CN201911018678.1A
Authority: CN
Inventors: 叶纪平; 阎昭; 徐文; 王雨萌
Original assignee: Beijing Xinyan Hui Pharmaceutical Research And Development Co ltd
Current assignee: Beijing Xinyan Hui Pharmaceutical Research And Development Co ltd
Priority date: 2019-10-24
Filing date: 2019-10-24
Publication date: 2021-04-27

Abstract

The invention provides a method for generating a clinical research schedule, which comprises the following steps: receiving clinical stage information for a clinical study; receiving information acquisition time formulas of all clinical stages; and generating a clinical research schedule according to the information acquisition time formula of each clinical stage. In addition, the invention also provides equipment and a system capable of realizing the method. The method, the equipment and the system for generating the clinical research mission schedule can automatically generate the clinical research mission schedule and can obviously improve the working efficiency of CRC.

Description

Method, device and system for generating clinical research time schedule

The technical field is as follows:

the invention relates to the field of clinical research implementation of medicines, in particular to a method, equipment and a system for generating a clinical research time schedule.

Background art:

with the rapid development of the new drug research and development industry in recent years, the clinical research demand of the drug enterprises in China is greatly increased. The clinical research has the characteristics of long research period, high cost for recruiting subjects and the like, and the workers who need to participate in the clinical research have strong speciality and sense of responsibility so as to ensure the smooth proceeding of the clinical research.

In clinical studies, the basic work was mainly done by clinical coordinators (CRC). Thus, CRC requires a large number of clinical tasks to be performed and subjects to be tracked or visited throughout the clinical study period, and thus the scheduling or scheduling of individual tasks is a necessary condition to ensure successful completion of the clinical study, while also consuming a lot of the work effort of CRC, a problem which is even more pronounced when there are a large number of subjects in the group. In addition, due to the characteristics of the clinical study of drugs, accurate clinical tasks and schedules cannot be determined at the beginning of clinical projects, for example, the number of treatment cycles of different subjects may be different, the group withdrawal condition which may occur in clinical studies, and the long-term follow-up after the treatment cycle is over, and these clinical events cannot accurately determine the start-stop time during planning, thereby further challenging the planning of clinical study schedules.

The invention content is as follows:

the present invention has been made to solve at least one of the problems occurring in the prior art.

Specifically, in a first aspect of the present invention, a method for generating a clinical research schedule is provided, which includes the following steps:

receiving clinical stage information for a clinical study;

receiving information acquisition time formulas of all clinical stages;

and generating a clinical research schedule according to the information acquisition time formula of each clinical stage.

Preferably, the information acquisition time formula comprises a starting point time stamp, a time width stamp of the clinical stage.

Preferably, the information collection time type further comprises a collection point interval mark for marking the time interval of a plurality of collection points.

Preferably, the information collection time format further comprises a collection point window time stamp for marking a time window of a certain collection point.

Preferably, the starting point time stamp can be represented by clinical stage number, calculation mode, distance time.

Preferably, the temporal width marker is the duration of a clinical phase.

Preferably, the time width mark comprises an acquisition point interval mark and an acquisition point interval realization time.

Preferably, the starting point time stamp may be an ending time of a certain clinical stage, the ending time being a time width end point from the starting point time.

Preferably, the start point timestamp comprises a first event start point timestamp, or a second event start point timestamp. Wherein the first event is a clinical stage determinable at the time of generation of the clinical study schedule and the second event is a clinical stage not determinable at the time of generation of the clinical study schedule.

Preferably, the clinical phase comprises at least one treatment period.

Preferably, the clinical stage comprises a screening phase.

Preferably, the clinical stage comprises a post-treatment follow-up.

Preferably, the start point time stamp may comprise a clinical task start point time stamp. The clinical task is a clinical task to be completed in a clinical research schedule.

More preferably, the clinical task onset time-stamp comprises a time-stamp of a first completion of a clinical task, or a time-stamp of a last completion of a clinical task, or a time-stamp of each completion of a clinical task.

In another aspect of the present invention, a method for generating a clinical research time plan is provided, which includes the following steps:

receiving clinical task information to be completed;

generating a clinical study schedule according to the method as described above;

receiving a matching instruction of the clinical task and the clinical stage.

Preferably, the clinical study time plan generating method further comprises the steps of:

frequency of operation information for a clinical task is received.

Preferably, the operation frequency information may be completed once in a unit time or may be completed unlimited times in a unit time. In the scheme, the completion times in the unit time are not limited, namely the completion times in the unit time are more than one time, and the scheme has no upper limit.

Preferably, the point of onset time stamp comprises a clinical task point of onset time stamp. More preferably, the clinical task onset time-stamp comprises a time-stamp of a first completion of a clinical task, or a time-stamp of a last completion of a clinical task, or a time-stamp of each completion of a clinical task.

remark information for a clinical task is received.

receiving an original name of a clinical task;

and generating a standard name of the clinical task according to the original name of the clinical task.

In another aspect of the present invention, a method for recording progress of a clinical research project is provided, which includes the following steps:

generating a clinical study time plan according to the method described above;

matching the clinical study time plan with the staff;

receiving a patient entry order;

receiving a patient selection instruction;

receiving treatment session start time data;

receiving a completion instruction of a clinical task;

end time data for the treatment session is received.

Preferably, the method for recording progress of a clinical research project further comprises the steps of: screening period start time data is received.

Preferably, the method for recording progress of a clinical research project further comprises the steps of: an occurrence time of a second event is received.

Preferably, the number of completion instructions of the received clinical task is matched with the operation frequency information.

Preferably, the method for recording progress of a clinical research project further comprises the steps of:

a clinical study end instruction is received.

In another aspect of the present invention, an apparatus is provided, which includes a memory, a processor, and a computer program stored on the memory and executable on the processor, the processor implementing the above clinical research schedule generation method when executing the program.

In another aspect of the invention, an apparatus is provided, comprising a memory, a processor and a computer program stored on the memory and executable on the processor, the processor implementing the above clinical study time plan generation method when executing the program.

In another aspect of the invention, there is provided an apparatus comprising a memory, a processor and a computer program stored on the memory and executable on the processor, the processor implementing the above method of progress recording of a clinical study when executing the program.

In another aspect of the present invention, there is provided a computer-readable storage medium having stored thereon a computer program which, when executed by a processor, implements the above-described clinical research schedule generation method.

In another aspect of the present invention, there is provided a computer-readable storage medium having stored thereon a computer program which, when executed by a processor, implements the above-described clinical study time plan generation method.

In another aspect of the present invention, there is provided a computer-readable storage medium having stored thereon a computer program which, when executed by a processor, implements the above-described method of progress recording of a clinical research project.

In another aspect of the present invention, there is provided a clinical research schedule generation system including:

a clinical stage information receiving module for receiving clinical stage information of a clinical study;

the information acquisition time receiving module is used for receiving the information acquisition time patterns of each clinical stage;

and the clinical research schedule generating module is used for generating a clinical research schedule according to the information acquisition time formula of each clinical stage.

Preferably, the information collection time format further comprises a collection point interval mark for marking a time interval of a plurality of collection points, and the collection point interval mark is used for marking a time interval of a plurality of collection points.

Preferably, the temporal width marker is the duration of a clinical phase.

Preferably, the clinical phase comprises at least one treatment period.

Preferably, the clinical stage comprises a screening phase.

Preferably, the clinical stage comprises a post-treatment follow-up.

In another aspect of the present invention, there is provided a clinical study time plan generating system including:

the clinical task receiving module is used for receiving clinical task information to be completed;

a clinical research schedule generation system as described above;

and the task matching module is used for receiving a matching instruction of the clinical task and the clinical stage.

Preferably, the clinical study time plan generating system further comprises:

and the operation frequency receiving module is used for receiving the operation frequency information of the clinical task.

Preferably, the clinical study time plan generating system further comprises:

and the remark information receiving module is used for receiving the remark information of the clinical task.

Preferably, the clinical study time plan generating system further comprises:

and the clinical task standard name generating system is used for receiving the original name of the clinical task and generating the clinical task standard name according to the original name of the clinical task.

In another aspect of the present invention, there is provided a progress recording system for a clinical research project, including:

a clinical study time plan generating system for generating a clinical study time plan according to the method as described above;

the personnel matching module is used for matching the clinical research time plan with the working personnel;

a patient entry module for receiving a patient entry order;

a patient selection module for receiving a patient selection instruction;

a treatment period start time receiving module for receiving treatment period start time data;

the clinical task completion module is used for receiving a completion instruction of a clinical task;

and the treatment period end time receiving module is used for receiving the treatment period end time data.

Preferably, the progress recording system for a clinical research project further comprises:

and the screening period starting time receiving module is used for receiving the screening period starting time data.

and the second event starting time receiving module is used for receiving the occurrence time of the second event.

a project end module to receive a clinical study project end instruction.

In conclusion, the invention has the following beneficial effects:

1. the method and the system for generating the clinical research mission schedule can automatically generate the clinical research mission schedule and can obviously improve the working efficiency of CRC.

2. The method and the system for generating the clinical research mission schedule can orderly arrange the clinical research mission schedule with uncertain start-stop time, such as the clinical research mission with an uncertain treatment period, increase the universality of the schedule, avoid the condition that schedule creation needs to be carried out again on different clinical researches and even different patients, and further improve the working efficiency of CRC.

3. The method and the system for generating the clinical research time plan match the clinical tasks with the clinical phases, improve the generation efficiency of the clinical research time plan, further, the method can also comprise the information of the completion frequency of the clinical tasks, avoid the temporary change of the clinical research time plan and improve the application efficiency of the plan.

4. According to the progress recording method and system for the clinical research project, provided by the invention, independent progress records are created for different patients, the work record of CRC is convenient, meanwhile, the work schedule of CRC can be reminded, and the work efficiency of CRC can be obviously improved.

Drawings

FIG. 1 is a system architecture diagram of a clinical trial resource statistics system of the present invention;

FIG. 2 is a flow chart of a resource statistical method for clinical trials according to the present invention;

FIG. 3 is a flowchart of a method for counting the workload of a CRA in a clinical program according to the present invention.

FIG. 4 is a schematic diagram of a clinical research schedule generation system of the present invention;

FIG. 5 is a schematic diagram of a clinical study time plan generation system of the present invention;

FIG. 6 is a schematic diagram of a progress recording system for a clinical study of the present invention.

The specific implementation mode is as follows:

the exemplary embodiments will be described herein in detail, and the embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Rather, they are merely examples of apparatus and methods consistent with certain aspects of the invention, as detailed in the appended claims.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used in this specification and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the term "and/or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

The present invention will be described in detail below by way of examples.

The embodiment of the application solves at least one technical problem in the prior art by providing a method and a system for generating a clinical research schedule, a method and a system for generating a clinical research time plan, and a method and a system for recording the progress of a clinical research project, and achieves the technical effect of generating the clinical research schedule more efficiently.

In order to solve the technical problems, the general idea of the embodiment of the application is as follows:

a clinical research schedule generation method comprises the following steps:

receiving clinical stage information for a clinical study;

receiving information acquisition time formulas of all clinical stages;

The clinical research task schedule generation method can automatically generate the clinical research task schedule, and can obviously improve the working efficiency of CRC.

In order to better understand the technical solution, the technical solution will be described in detail with reference to the drawings and the specific embodiments.

Example 1

Specifically, as shown in fig. 1, the present invention provides a method for generating a clinical research schedule, which comprises the following steps:

s101, receiving clinical stage information of a clinical study;

in practice, the clinical phase information includes the various phases of the clinical study including, but not limited to: screening period, treatment period, unplanned visit, treatment end visit (EOT visit), safety follow-up visit, long-term follow-up visit and the like. In the clinical phase, a clinical coordinator (CRC) needs to collect information about a patient to record the clinical condition of the patient. The content of the information collection includes, but is not limited to, informed consent, medical history collection, physical examination, hematuria examination, and the like.

As an alternative embodiment, after receiving clinical stage information for a clinical study, each clinical stage is uniquely labeled, which may be an ID number consisting of numbers and/or letters.

S102, receiving information acquisition time formulas of all clinical stages;

in a specific implementation process, the information collection time formula may be time and/or times for collecting information of a patient in each clinical stage, the information collection time may be a certain time point or a certain time period, and the times may be one time, multiple times, or unlimited times.

And S103, generating a clinical research schedule according to the information acquisition time formula of each clinical stage.

In particular implementations, the clinical study schedule is generated by matching the clinical phases and the times at which the acquisitions are made in each clinical phase.

As an alternative embodiment, the information collection time formula includes a starting point time stamp and a time width stamp of the clinical stage.

In a specific implementation, the starting point timestamp may be represented by: (clinical stage number + calculation mode + distance time) indicates that the starting point timestamp may be a fixed time point or a time point related to the ending time of a certain clinical stage, i.e. the starting point timestamp of a certain clinical stage includes the ending time of another clinical stage associated with the starting point timestamp. The way to mark a certain fixed point in time may be: the time point associated with the start time of a clinical stage, such as a start time timestamp relative to the start time of the treatment session, may be, in particular, if the letter a is used to indicate the start time of the clinical phase, the first cycle ID of the treatment period is set to 01, the start time of the first cycle of the treatment period is 01a1 (where 01 is the clinical stage number, a is the calculation, 1 is the distance time, and may be omitted when the distance time is 1), the screening period should start 28 days before the treatment period, the time of the onset of the screening period is labeled 01A-28 and the second period of the treatment period begins on day 29 after the first period of the treatment period, then the time of the onset of the second period of the treatment period is labeled 01A29, other clinical stages may be time-stamped with the same logic as the starting point, representing the starting time of the entire clinical study when A is not currently labeled with an ID value; when multiple clinical phases share the same starting time, such as the unscheduled visit beginning in the first cycle of the treatment period, and the planned visit ID is designed to be 05, the label of the unscheduled visit at this time may be 01A1, or may be represented by 01A (starting time of a certain phase, which is 1), it should be noted that a certain clinical phase may only refer to IDs of other clinical phases as a component of the starting point time label. The manner in which the starting point time is marked as the time point associated with the end time of a certain clinical phase may be: the starting point time marking is carried out by taking the ending time of a certain clinical stage as a reference time, specifically, if the letter B is used for indicating the ending time of the clinical stage (B is a calculation mode), the ending time of a treatment period is marked as treatment period ID + B, if the treatment period ID is 01, the ending time of the treatment period is 01B, the clinical stage taking the ending time of the treatment period as the starting time, such as the starting point time marking of a visit at the end of the treatment is 01B1 (the starting time of the period is the 1 st day at the end of the treatment), the starting point time marking of a safe visit after the end of the treatment is 01B28 (the starting time of the period is the 28 th day at the end of the treatment), and when an ID value is not added before B, the starting point time marking represents the ending time of the whole clinical study. In particular implementations, the temporal width marker is used to mark the temporal width of a clinical stage, which may be the duration of a clinical stage. If the treatment period lasts for 100 days by taking the starting time of the treatment period as a reference time, the starting point time mark and the time width mark are expressed as follows: A1100. further, the reference time is a time that the CRC needs to be acquired when the clinical item is started, such as the grouping time of the patient, the screening period start time, the treatment period start time, and the like, that is, the information acquisition time formula includes a first reference time acquisition mark (i.e., a in the time mark of the starting point), and the first reference time acquisition mark is a time that needs to be acquired when the clinical item is started. By adopting the method, the time period of the clinical stage can be simply and accurately described by the information acquisition type, and a foundation is provided for generating a complete clinical schedule.

As an optional implementation mode, the information acquisition time type further comprises an acquisition point interval mark used for marking the time interval of a plurality of acquisition points.

In a specific implementation process, one or more times of data acquisition is required for CRC in a certain clinical stage, for example, in a screening period, CRC only needs to perform one-time information acquisition on a patient, and acquisition point interval marking is not required to be performed in the clinical stage; however, in some clinical phases, such as a first year of a long-term visit, it is necessary to perform information acquisition on a patient every 3 months, where 3 months are acquisition point intervals, and the intervals can be marked with 3m, i.e. acquisition point intervals are marked. If the clinical phase of the first year's extended visit is labeled with an initial time of 4 months after the receipt of the treatment session, data is collected 1 time every 3 months with a time width of 1 year, assuming that the treatment session ID is 01, the information collection time formula for the first year's extended visit is 01B4m (starting point time marker) 3m (collection point interval marker) < ═ 1y (time width marker). It will be appreciated by those skilled in the art that the collection point interval indicia may also take the form of days or weeks or years, with time intervals being marked, such as a time interval being marked with 30d (i.e., 30 days), 4w (i.e., 4 weeks), 1y (i.e., 1 year). By adopting the acquisition point interval mark, clinical stages which need to be repeated for many times can be represented in an information acquisition time formula, and the generation efficiency of the clinical schedule is improved.

As an optional implementation, the information collection time formula further includes a collection point window time stamp for marking a time window of a certain collection point.

In the specific implementation process, different clinical stages have different requirements on the time point of CRC acquisition of patient information, for example, when treatment is finished, visit needs are finished on the day of treatment finishing, and no window period exists; during the treatment period, the information acquisition of the patient can be performed within 3 days before and after the expected acquisition point, that is, a 7-day window period exists, and the window time mark of the acquisition point can be expressed by + -3d or + -3 d. The window time of the acquisition point is marked, so that the flexibility of generating the clinical schedule is improved, and the actual operation condition of clinical work is better met.

As an optional embodiment, the time width mark comprises an acquisition point interval mark and an acquisition point interval realization time.

In a specific implementation process, a clinical stage with a fixed period being undeterminable exists, for example, a long-term visit, the time end point of the stage being undeterminable, for example, a long-term visit starting 4 months after the expiration of a treatment period, information acquisition is performed on a patient every 6 months until the death of the patient or the termination of a clinical drug test, T represents the acquisition point interval implementation number, the time width of the long-term visit is 6m > -1T, and the information acquisition time formula of the clinical stage is B4m 6m > -1T. The clinical stage of a fixed period can not be determined, the clinical stage often appears in clinical work, and the situation which is difficult to process by clinical schedule making personnel is always the situation. In the specific work of CRC, an acquisition entry is required for the end time of this clinical phase to end the clinical phase.

As an alternative embodiment, the starting point time stamp may be the end time of a certain clinical stage, the end time being the end of the time width from the starting point time.

In the specific implementation process, the end time of a certain clinical stage is taken as a starting point time mark, specifically, for example, the starting time mark of a questionnaire after treatment is set by taking the starting time of a treatment period as a reference time, the treatment period ID is set to be 01, the treatment period lasts for 100 days, and the starting point time mark and the time width mark are used for representing the treatment period: ID01 ═ a1100, and the letter B indicates the end time of the clinical phase, the end time of the treatment session is marked as treatment session ID + B, the end time of the treatment session is 01B, and if the end time of the treatment session is taken as the start time of the post-treatment questionnaire, the start time of the phase is marked as 01B, where 01B is the end of the time span (i.e., 100) from the start time of the treatment session (i.e., A1) (i.e., a 1100). Thus, in some preferred embodiments, the information acquisition timeline further includes a second reference time acquisition marker (i.e., 01B of the markers above) that marks the end time of the treatment session. In the scheme, different clinical stages are associated through the end time, the efficiency of generating the clinical schedule can be improved, and further, under the condition that the clinical stages with the fixed periods cannot be determined, the subsequent scheme can be associated with the clinical stages with the fixed periods that cannot be determined through the end time point by adopting the scheme, so that the clinical schedule is more integral and more practical.

As an alternative embodiment, the starting point time stamp includes a first event starting point time stamp, or a second event starting point time stamp.

In a specific implementation process, the first event is a clinical stage that can be determined when a clinical research schedule is generated, such as a screening period, a treatment period, follow-up visits after treatment and the like; while the second event is not determinable at the time of generation of the clinical study schedule, but the clinical stages involved in the clinical trial protocol, as particularly indicated in the clinical trial protocol, should be administered with the corresponding medication within 1 week when the patient's body temperature exceeds 39 ℃, or should be bandaged within 2 days if the patient is fractured, etc. The time stamp of the starting point of the second event can be represented by H (H is a calculation method), and if the ID of the event of fracture is 02, the clinical stage of performing the wrapping treatment within 2 days after the fracture is: 02H 12; similarly, assuming that the ID of the event of hyperthermia is 01, the clinical phase of taking the drug within 1 week after hyperthermia would be: 01H11 w. By adopting the time mark of the starting point of the second event, the clinical stage of uncertain time when the clinical research schedule is generated can be introduced, and the flexibility and the practicability of the clinical schedule are improved.

As an alternative embodiment, the clinical phase comprises at least one treatment period.

In practice, the number of cycles for the treatment period of the clinical study for different patients cannot be determined at the beginning of the program, and the treatment period may last one cycle, two cycles, or more. CRC entails acquiring time data at the start of an initial treatment session, determining the start time of the treatment session for the patient, acquiring time data at the end of the treatment session, and determining the end time of the treatment session for the patient. Thus, for treatment periods where time cannot be determined, the time width indicia may be expressed in terms of the number of acquisition point interval markers and acquisition point interval realizations.

As an alternative embodiment, the clinical phase comprises a screening phase.

In a specific implementation, the screening period is set before the treatment period, the patient is screened, and the starting time of the screening period can be collected by CRC.

As an alternative embodiment, the clinical phase comprises a post-treatment follow-up.

In practice, for patients who end treatment, a post-treatment follow-up visit is also performed, the follow-up time of which cannot be determined at the beginning of the program, and may be 1 year, 2 years, or several years until the program ends or the patient dies. Therefore, for a follow-up period for which time cannot be determined, the time width mark may be expressed in terms of the acquisition point interval mark, and the acquisition point interval realization times.

As an alternative embodiment, the start point time stamp may comprise a clinical task start point time stamp.

In a specific implementation, the clinical task is a clinical task to be completed in a clinical research schedule, such as signing informed consent, blood routine examination, urine routine examination, electrocardiogram, blood pressure monitoring, and the like. Further, the clinical task starting point time stamp includes a time stamp of a first completion of the clinical task, or a time stamp of a last completion of the clinical task, or a time stamp of each completion of the clinical task. When the time stamp of the starting point of the clinical task includes the time stamp of the first completion of the clinical task, it can be represented by F (F is the calculation method), and if the ID of the blood routine examination is 03, the electrocardiographic examination is performed within 10 days after the first completion of the blood routine examination, and the clinical stage should be: 03F 110; when the time stamp of the starting point of the clinical task includes the time stamp of the last completion of the clinical task, it can be represented by G (G is the calculation mode), and assuming that the ID of the blood routine test is 03, the urine routine test is performed within 10 days after the last completion of the blood routine test, and the clinical stage is: 03G 110; when the time stamp of the starting point of the clinical task includes the time stamp of each completion of the clinical task, it can be represented by E (E is the calculation mode), and assuming that the ID of the blood routine examination is 03, blood pressure monitoring is performed within 1 week after each completion of the blood routine examination, and then the clinical phase should be: 03E11 w. The starting point time is associated with the clinical task, the matching of the clinical schedule and the clinical task is increased, the time association of the clinical stage and the clinical task can be realized, and the flexibility and the practicability of the clinical schedule are increased.

Example 2

As shown in fig. 2, the present invention further provides a method for generating a clinical study time plan, comprising the following steps:

s201, receiving clinical task information to be completed;

in particular implementations, the creator of the clinical study time plan enters information on clinical tasks to be completed, which in some embodiments include informed consent, qualification criteria confirmation, medical history investigation, smoking status investigation, physical examination, questionnaire filling, weight examination, height examination, electrocardiographic examination, hematological examination, biochemical examination, urinalysis, etc., which clinical tasks require one or more sessions in a clinical study.

S204, generating a clinical research schedule according to the method;

in specific implementations, a clinical study schedule is generated using any of the methods described in example 1.

And S205, receiving a matching instruction of the clinical task and the clinical stage.

In the specific implementation process, a creator of the clinical research time plan matches the clinical task with the clinical research schedule, the clinical schedule is composed of a plurality of clinical stages, namely, data of which clinical tasks need to be completed in a certain clinical stage is obtained through matching, the data can be embodied in a terminal device in a form of a table, and meanwhile, the data can also be embodied in a mobile terminal of CRC in a form of a working calendar, so that the schedule can be conveniently checked through CRC. In some embodiments, the CRC can process the task to be completed at the mobile terminal, so as to record the completed task, thereby significantly saving the time of CRC in the registration work, and improving the work efficiency thereof.

As an alternative embodiment, the method for generating a clinical study time plan further comprises the steps of:

and S206, receiving operation frequency information of the clinical task.

In a specific implementation process, after a clinical task is matched with a clinical stage, operation frequency information of the clinical task is input, wherein the operation frequency information can be completed once in unit time, for example, an informed consent in a screening period only needs to be completed once; or completing several times in unit time, such as completing a certain task three times in a month; or more than one time per unit time without upper limit, such as an unlimited number of weight measurement tasks can be completed in a treatment period. By adopting the scheme, the recording times of the same task can be reduced, the generation efficiency of the clinical research time plan is increased, and the applicability of the plan can be further improved.

In a specific implementation, the clinical task is a clinical task to be completed in a clinical research schedule, such as signing informed consent, blood routine examination, urine routine examination, electrocardiogram, blood pressure monitoring, and the like. Further, the clinical task starting point time stamp includes a time stamp of a first completion of the clinical task, or a time stamp of a last completion of the clinical task, or a time stamp of each completion of the clinical task. Wherein, when the time stamp of the starting point of the clinical task includes the time stamp of the first completion of the clinical task, it can be represented as F, and if the ID of the blood routine test is 03, the electrocardiographic test is performed within 10 days after the first completion of the blood routine test, and the clinical stage is: 03F 110; when the time stamp of the starting point of the clinical task includes the time stamp of the last completion of the clinical task, it can be indicated as G that, assuming that the ID of the blood routine examination is 03, the urine routine examination is to be performed within 10 days after the last completion of the blood routine examination, and the clinical phase should be: 03G 110; when the time stamp of the starting point of the clinical task includes the time stamp of each completion of the clinical task, which can be represented by E, assuming that the ID of the blood routine examination is 03, the blood pressure monitoring is performed within 1 week after each completion of the blood routine examination, and then the clinical phase should be: 03E11 w. The starting point time is associated with the clinical task, the matching of the clinical schedule and the clinical task is increased, the time association of the clinical stage and the clinical task can be realized, and the flexibility and the practicability of the clinical schedule are increased.

and S203, receiving remark information of the clinical task.

In a specific implementation process, the remark information may be a notice, an operation requirement, and the like of the clinical task, and is associated with the clinical task, and the CRC may see the remark information when the mobile terminal operates, so as to facilitate the operation of the CRC, and also reduce the probability of an error occurring in the clinical task.

s202, receiving an original name of a clinical task;

In the implementation process, different clinical plan creators may have different names for the same clinical task, and the project management at the later stage is inconvenient. Therefore, in this embodiment, the common name of the clinical task is entered and uploaded to the database in advance, and after the original name of the clinical task is entered, the creator needs to convert the original name into the common name, which may be selected from the common name library.

Example 3

As shown in fig. 3, the present invention further provides a progress recording method for a clinical research project, comprising the following steps:

s301, generating a clinical study time plan according to the method described above;

in specific implementations, a clinical study time plan is generated using any of the methods described in example 2.

S302, matching the clinical research time plan with a worker;

in a specific implementation process, the clinical research time plan generated in S301 is matched with corresponding staff in the system, and the staff can obtain the corresponding clinical research time plan through a terminal device such as a mobile phone by means of account login and the like, wherein the obtaining mode can be realized through an applet or an APP of the mobile terminal. The worker may be CRC.

S303, receiving a patient input instruction;

in the specific implementation process, after the clinical study time plan is matched with the corresponding clinical study time plan, the staff can formally start the clinical study plan, and at the moment, information input such as the group entry time, the name and the like needs to be carried out on the group entry patients. The staff needs to perform information collection of clinical tasks on the grouped patients with the input information according to a clinical study time plan.

S304, receiving a patient selection instruction;

in the specific implementation process, different patients entering the group have independent clinical task data, and a worker needs to select the patients before acquiring the clinical task information of a certain patient.

S306, receiving the data of the starting time of the treatment period;

in the specific implementation process, after the staff selects the corresponding patient to be enrolled, the enrollment time of the patient is entered, namely the reference time acquisition mark in the information acquisition time formula, and at this time, the clinical phase time related to the reference time in the clinical research time plan can be determined. In some embodiments, after entering the patient grouping time, the clinical study time plan is updated in the working calendar of the staff mobile terminal, so that the staff can conveniently view the time plan and schedule the working time.

S307, receiving a completion instruction of the clinical task;

in the specific implementation process, after a certain patient is selected to be grouped, the staff collects corresponding clinical task information of the patient in a corresponding working stage, and after the task is completed, the corresponding task is marked to be completed. In some embodiments, the worker may perform the completion operation through the mobile terminal, and the completion operation may be implemented by clicking a corresponding task in the applet or APP.

S308, receiving the data of the end time of the treatment period.

In practice, due to the uncertainty of the treatment session, the staff member needs to enter the end time of the treatment session at the end of the patient treatment session to determine the task time of the subsequent clinical phase of the treatment session.

As an alternative embodiment, the method for recording the progress of a clinical research project further comprises the steps of:

s305, receives the screening period start time data.

In the specific implementation process, the staff can record the data of the screening period starting time from the beginning of the screening period of the patient, and further accurately mark the time of the whole scheme.

In an alternative embodiment, the number of instructions to complete the received clinical task is matched to the operation frequency information.

In certain embodiments, different clinical tasks are performed at different frequencies, including a determinable number of times, such as 1, 2, etc., and an indeterminate number of times, such as an infinite number of times. When the operation frequency of the clinical task is determined, the staff needs to finish the corresponding operation frequency and operate on the terminal equipment, and after the corresponding operation frequency is finished, the project can not be operated any more and is in a finished state; when the operation frequency of the clinical task is uncertain, the staff needs to complete the task at least once, the project can be operated all the time, and the system records the operation frequency of the project. By adopting the scheme, the same operation content can be displayed as the same item, and the operation of workers is facilitated.

and S315, receiving the occurrence time of the second event.

In particular implementations, the second event is not determinable at the time of generation of the clinical study schedule, but the clinical phases involved in the clinical trial protocol require the clinical coordinator or other staff member to collect such events in the clinical study, so as to trigger and generate the corresponding clinical phases, which in turn correspond to the corresponding clinical tasks.

As an alternative embodiment, the method for recording progress of a clinical research project further comprises the steps of:

and S309, receiving a clinical research project ending instruction.

In practice, the end time of a clinical study of a patient requires a staff acquisition to accurately determine the end time, since there is a long-term visit after the treatment period, which may accompany the patient for a long period of time or even for a lifetime.

Example 4

The invention provides an apparatus comprising a memory, a processor and a computer program stored on the memory and executable on the processor, the processor when executing the program implementing the clinical research schedule generation method of claim 1.

Example 5

The invention provides an apparatus comprising a memory, a processor and a computer program stored on the memory and executable on the processor, the processor when executing the program implementing the clinical study time plan generation method of claim 2.

Example 6

The present invention provides an apparatus comprising a memory, a processor and a computer program stored on the memory and executable on the processor, the processor when executing the program implementing a method of progress recording for a clinical study according to claim 3.

Example 7

The present invention provides a computer-readable storage medium, on which a computer program is stored which, when being executed by a processor, carries out the method of generating a clinical research schedule according to claim 1.

Example 8

The present invention provides a computer-readable storage medium, on which a computer program is stored which, when being executed by a processor, carries out the method of generating a clinical study time plan as claimed in claim 2.

Example 9

The present invention provides a computer-readable storage medium having stored thereon a computer program which, when executed by a processor, implements the method of progress recording for a clinical research project according to claim 3.

Example 10

As shown in fig. 4, the present invention provides a clinical research schedule generation system, comprising:

In particular implementations, the module generates a schedule for the clinical study by matching the clinical phases and the times at which the acquisitions are required in each clinical phase.

In an implementation, the starting point time stamp may be a fixed time point, or may be a time point related to an ending time of a clinical phase. The way to mark a certain fixed point in time may be: a time point related to the start time of a certain clinical phase, for example, the start time is time-stamped by taking the start time of a treatment period as a reference time, specifically, if the letter a is used to represent the start time of the clinical phase, and if the first period ID of the treatment period is 01, the start time of the first period of the treatment period is 01A1, the screening period should start 28 days before the treatment period, the start time of the screening period is time-stamped by 01A-28, the second period of the treatment period starts 29 days after the first period of the treatment period, the start time of the second period of the treatment period is time-stamped by 01A29, and other clinical phases may be time-stamped by the same logic; when multiple clinical phases share the same starting time, if the unscheduled visit also starts in the first period of the treatment period, and the ID of the unscheduled visit is designed to be 05, the label of the unscheduled visit at this time can be 01A1, or can be represented by 01A, and it should be noted that a certain clinical phase can only refer to the IDs of other clinical phases as the components of the starting point time labels. The manner in which the starting point time is marked as the time point associated with the end time of a certain clinical phase may be: specifically, if the letter B is used to indicate the end time of the clinical phase, the end time of the treatment period is marked as treatment period ID + B, if the treatment period ID is 01, the end time of the treatment period is 01B, and the clinical phase with the end time of the treatment period as the start time, such as the start time of the visit at the end of the treatment period marked as 01B1 (the start time of the period is day 1 at the end of the treatment), and the start time of the safe visit after the end of the treatment marked as 01B28 (the start time of the period is day 28 at the end of the treatment). In particular implementations, the temporal width marker is used to mark the temporal width of a clinical stage, which may be the duration of a clinical stage. If the treatment period lasts for 100 days by taking the starting time of the treatment period as a reference time, the starting point time mark and the time width mark are expressed as follows: A1100. further, the reference time is a time that the CRC needs to be acquired when the clinical item is started, such as the grouping time of the patient, the screening period start time, the treatment period start time, and the like, that is, the information acquisition time formula includes a first reference time acquisition mark (i.e., a in the time mark of the starting point), and the first reference time acquisition mark is a time that needs to be acquired when the clinical item is started. By adopting the method, the time period of the clinical stage can be simply and accurately described by the information acquisition type, and a foundation is provided for generating a complete clinical schedule.

In a specific implementation process, one or more times of data acquisition is required for CRC in a certain clinical stage, for example, in a screening period, CRC only needs to perform one-time information acquisition on a patient, and acquisition point interval marking is not required to be performed in the clinical stage; however, in some clinical phases, such as a first year of a long-term visit, it is necessary to perform information acquisition on a patient every 3 months, where 3 months are acquisition point intervals, and the intervals can be marked with 3m, i.e. acquisition point intervals are marked. If the clinical phase of the first year's extended visit is labeled with an initial time of 4 months after the receipt of the treatment session, data is collected 1 time every 3 months with a time width of 1 year, assuming that the treatment session ID is 01, the information collection time formula for the first year's extended visit is 01B4m (starting point time marker) 3m (collection point interval marker) < ═ 1y (time width marker). By adopting the acquisition point interval mark, clinical stages which need to be repeated for many times can be represented in an information acquisition time formula, and the generation efficiency of the clinical schedule is improved.

In a specific implementation process, the first event is a clinical stage that can be determined when a clinical research schedule is generated, such as a screening period, a treatment period, follow-up visits after treatment and the like; while the second event is not determinable at the time of generation of the clinical study schedule, but the clinical stages involved in the clinical trial protocol, as particularly indicated in the clinical trial protocol, should be administered with the corresponding medication within 1 week when the patient's body temperature exceeds 39 ℃, or should be bandaged within 2 days if the patient is fractured, etc. The time stamp of the starting point of the second event can be represented as H, and assuming that the ID of the event of fracture is 02, the clinical stages of the dressing treatment within 2 days after the fracture are: 02H 12; similarly, assuming that the ID of the event of hyperthermia is 01, the clinical phase of taking the drug within 1 week after hyperthermia would be: 01H11 w.

As an alternative embodiment, the clinical phase comprises a screening phase.

Example 11

As shown in FIG. 5, the present invention provides a clinical study time plan generation system comprising:

in particular implementations, the creator of the clinical study time plan enters information on clinical tasks to be completed, which in some embodiments include informed consent, qualification criteria confirmation, medical history survey, smoking status survey, physical examination, questionnaire filling, weight examination, height examination, electrocardiographic examination, hematological examination, biochemical examination, urinalysis, etc., via a clinical task receiving module, which is a clinical task in a clinical study that requires one or more sessions.

The clinical study schedule generation system of embodiment 10;

the task matching module is used for receiving a matching instruction of a clinical task and a clinical stage;

in a specific implementation process, a creator of a clinical research time plan matches a clinical task with a clinical research schedule through a task matching module, the clinical schedule is composed of a plurality of clinical stages, namely, data of which clinical tasks need to be completed in a certain clinical stage is obtained through matching, the data can be embodied in a terminal device in a form of a table, and meanwhile, the data can also be embodied in a mobile terminal of CRC in a working calendar form, so that the schedule can be conveniently checked through CRC. In some embodiments, the CRC can process the task to be completed at the mobile terminal, so as to record the completed task, thereby significantly saving the time of CRC in the registration work, and improving the work efficiency thereof.

As an alternative embodiment, the clinical study time plan generating system further includes:

In a specific implementation process, after a clinical task is matched with a clinical stage, operation frequency information of the clinical task is input through an operation frequency receiving module, wherein the operation frequency information can be completed once in unit time, for example, an informed consent in a screening period only needs to be completed once; or completing several times in unit time, such as completing a certain task three times in a month; or more than one time per unit time without upper limit, such as an unlimited number of weight measurement tasks can be completed in a treatment period. By adopting the scheme, the recording times of the same task can be reduced, the generation efficiency of the clinical research time plan is increased, and the applicability of the plan can be further improved.

Example 12

As shown in FIG. 6, the present invention provides a progress recording system for a clinical research project, comprising:

a clinical study time plan generation system as described in example 11;

in the specific implementation process, the clinical research time plan generated by the clinical research time plan generation system is matched with corresponding personnel in the system, the personnel can obtain the corresponding clinical research time plan through terminal equipment such as a mobile phone in a mode of account login and the like, and the obtaining mode can be realized through a small program or an APP of a mobile terminal. The worker may be CRC.

A patient entry module for receiving a patient entry order;

in a specific implementation process, after the clinical study time plan is matched with the corresponding clinical study time plan, a worker can formally start the clinical study plan, and at this time, information entry such as the group entry time, the name and the like needs to be performed on the group entry patient through the patient entry module. The staff needs to perform information collection of clinical tasks on the grouped patients with the input information according to a clinical study time plan.

A patient selection module for receiving a patient selection instruction;

in the specific implementation process, different patients entering the group have independent clinical task data, and before the staff collects the clinical task information of a certain patient, the staff needs to select the patient by using a patient selection module.

in the specific implementation process, after the staff selects the corresponding patient to be enrolled, the enrollment time of the patient, that is, the reference time acquisition mark in the information acquisition time formula, is entered through the treatment period start time receiving module, and at this time, the clinical phase time related to the reference time in the clinical research time plan can be determined. In some embodiments, after entering the patient grouping time, the clinical study time plan is updated in the working calendar of the staff mobile terminal, so that the staff can conveniently view the time plan and schedule the working time.

in the specific implementation process, after a certain patient is selected to be grouped, the staff collects corresponding clinical task information of the patient in a corresponding working stage, and after the task is completed, the corresponding task is marked by the clinical task completion module. In some embodiments, the worker may perform the completion operation through the mobile terminal, and the completion operation may be implemented by clicking a corresponding task in the applet or APP.

In the specific implementation process, due to the uncertainty of the treatment period, the staff needs to record the end time of the treatment period through the treatment period end time receiving module when the treatment period of the patient is ended so as to determine the task time of the subsequent clinical stage of the treatment period.

As an alternative embodiment, the progress recording system of the clinical research project further comprises:

a project end module to receive a clinical study project end instruction.

In practice, the end time of a clinical study for a patient requires a staff member to collect it via the end of project module to accurately determine the end time, since there is a long-term visit after the treatment period, which may accompany the patient for a long period of time or even for a lifetime.

Those of ordinary skill in the art will appreciate that the various illustrative elements and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware or combinations of computer software and electronic hardware. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the implementation. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present invention.

In the several embodiments provided in the present application, it should be understood that the disclosed system, apparatus and method may be implemented in other ways. In addition, the shown or discussed mutual coupling or direct coupling or communication connection may be an indirect coupling or communication connection through some interfaces, devices or units, and may be in an electrical, mechanical or other form.

The units described as separate parts may or may not be physically separate, and parts displayed as units may or may not be physical units, may be located in one place, or may be distributed on a plurality of network units. Some or all of the units can be selected according to actual needs to achieve the purpose of the solution of the embodiment.

In addition, functional units in the embodiments of the present invention may be integrated into one processing unit, or each unit may exist alone physically, or two or more units are integrated into one unit.

It should be understood that the technical problems can be solved by combining and combining the features of the embodiments from the claims.

The functions, if implemented in the form of software functional units and sold or used as a stand-alone product, may be stored in a computer readable storage medium. Based on such understanding, the technical solution of the present invention may be embodied in the form of a software product, which is stored in a storage medium and includes instructions for causing a computer device (which may be a personal computer, a server, or a network device) to execute all or part of the steps of the method according to the embodiments of the present invention. And the aforementioned storage medium includes: a U-disk, a removable hard disk, a Read-Only Memory (ROM), a Random Access Memory (RAM), a magnetic disk or an optical disk, and other various media capable of storing program codes.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A clinical research schedule generation method comprises the following steps:

receiving clinical stage information for a clinical study;

receiving information acquisition time formulas of all clinical stages;

2. The clinical research schedule generation method of claim 1, wherein: the information collection time formula comprises a starting point time mark and a time width mark of the clinical stage.

3. The clinical research schedule generation method of claim 2, characterized in that: the information acquisition time type also comprises an acquisition point interval mark which is used for marking the time interval of a plurality of acquisition points.

4. The clinical research schedule generation method according to claim 2 or 3, characterized in that: the information acquisition time type also comprises an acquisition point window time mark which is used for marking the time window of a certain acquisition point.

5. The clinical research schedule generation method of claim 2, characterized in that: the time width mark comprises an acquisition point interval mark and acquisition point interval realization times, and the acquisition point interval mark is used for marking the time intervals of a plurality of acquisition points.

6. The clinical research schedule generation method of claim 2 or 4, characterized in that: the starting point time stamp may be an ending time of a certain clinical stage, the ending time being an end of a time width from the starting point time.

7. A clinical study time plan generation method comprising the steps of:

receiving clinical task information to be completed;

generating a clinical study schedule according to the method of generating a clinical study schedule according to any of the preceding claims 1-6;

receiving a matching instruction of the clinical task and the clinical stage.

8. The clinical study time plan generation method of claim 7, characterized in that: the clinical study time plan generating method further comprises the following steps:

frequency of operation information for a clinical task is received.

9. The clinical study time plan generation method of claim 8, characterized in that: the operation frequency information is completed once in unit time or is completed unlimited times in unit time.

10. The clinical study time plan generation method according to claim 7 or 8, characterized in that: the clinical study time plan generating method further comprises the following steps:

remark information for a clinical task is received.

11. A method of recording progress of a clinical research project, comprising the steps of:

generating a clinical study time plan according to the method of generating a clinical study time plan according to any one of claims 7-10;

matching the clinical study time plan with the staff;

receiving a patient entry order;

receiving a patient selection instruction;

receiving treatment session start time data;

receiving a completion instruction of a clinical task;

end time data for the treatment session is received.

12. The method of progress recording of a clinical research project of claim 11, wherein: the number of times of receiving the completion instructions of the clinical task is matched with the operation frequency information.

13. An apparatus comprising a memory, a processor, and a computer program stored on the memory and executable on the processor, the processor when executing the program implementing the clinical research schedule generation method of any of claims 1-6.

14. An apparatus comprising a memory, a processor and a computer program stored on the memory and executable on the processor, the processor when executing the program implementing the clinical study time plan generation method of any of claims 7-10.

15. An apparatus comprising a memory, a processor and a computer program stored on the memory and executable on the processor, the processor when executing the program implementing the method of progress recording of a clinical study according to claim 10 or 11.

16. A clinical research schedule generation system comprising:

17. A clinical study time plan generation system comprising:

a clinical research schedule generation system as described above;

18. A progress recording system for a clinical research project, comprising:

a patient entry module for receiving a patient entry order;

a patient selection module for receiving a patient selection instruction;