JP2001134674A - Test data total system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a test data total system capable of guaranteeing a GLP or the like by leaving the change history of input data even when the change of the input data is required by any reason. SOLUTION: This system is provided with a data input means 3 for inputting data provided as a result of a test, an input data storage part 4 for storing the inputted data and a data change history storage part 8 for storing the history at the time of changing the data stored in this input data storage part 4. By leaving the change history of the input data, even when the change of the input data is required by any reason, the GLP or the like can be guaranteed.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a test data summarizing system for summing up findings such as symptom changes in a living body when a drug is administered to the living body.

[0002]

2. Description of the Related Art The safety of humans, such as carcinogenicity and toxicity of pharmaceuticals, pesticides, food additives, and other chemical substances, is tested in clinical trials before they are marketed.
Confirmation has been performed in non-clinical tests using animals such as rats and mice.

[0003] In a safety test of a drug or the like using such an animal, toxicity is generated if the dose is administered to a single dose.
Single-dose toxicity study to clarify the characteristics of the toxicity, doses that show toxic and repeatable toxicities at repeated doses, and repeat-dose toxicology studies that characterize the toxicity, parent animals Reproductive and developmental toxicity tests to clarify the effects on the reproduction and development of the next generation, and mutagenicity tests to clarify the presence or absence of DNA-damaging substances and mutagenic properties. Various tests such as a carcinogenicity test, a skin sensitization test, a skin photosensitization test, and a dependence test are performed.

[0004] In each of the above tests, a drug is actually administered to an animal, the amount of body weight, food, water, urine, etc. is measured, clinical symptoms are observed, and pathological findings are observed. It is done by doing.

[0005] Such a safety test is carried out prior to a clinical test in which the drug is actually administered to the human body, and ultimately affects the human body. You need to understand and analyze the impact accurately. For this reason, computer systems have been used for data recording, management and analysis.

[0006] As described above, since drugs such as pharmaceuticals affect the human body, data management in the above-described safety test is performed so that the data is not falsified. Strict standards are set by the government and other government agencies. Such criteria are collectively referred to as “GLP (Good Laboratory Pr.)
), and of course, the computer system that manages the data must also meet the GLP standards, and the aggregated data is collected so that the entered and aggregated data is not falsified later. , Cannot be changed at the time of output.

Here, the safety test as described above is performed according to the following equation (1).
Data collection is carried out in a rotating manner by a plurality of personnel, since the animals are bred from 00 to more than 1000 animals and are continuously collected almost every day for about 1-2 years. And if it is numerical data such as weight, it does not cause much problem, but regarding the findings of clinical symptoms,
Even for the same symptom, variations in expression among observers are inevitable. For example, it is often the case that a finding that one observer describes as "rough" is described as "whirling" by another observer.

[0008]

[Problems to be solved by the invention]

However, in the conventional system, GL
In order to guarantee P, the total data of the input clinical symptoms and pathological findings cannot be changed at the time of output. For this reason, despite the fact that the symptoms and findings are actually the same, there is a possibility that the data may be treated as completely different data just because the expression is different. as a result,
There has been a problem that a retest must be performed to confirm a slight tendency, or in the worst case, the tendency of the symptoms cannot be caught and changes in the symptoms may be overlooked.

The present invention has been made in view of such circumstances, and by leaving a change history of input data, even if it becomes necessary to change input data for any reason,
An object of the present invention is to provide a test data totaling system that can guarantee GLP and the like.

[0011]

In order to achieve the above object, a test data totaling system according to the present invention is a test data totalizing system for totalizing data obtained as a result of a test, wherein a data input for inputting data is provided. The gist of the present invention is to include a means, an input data storage unit for storing input data, and a history storage unit for storing a history when data stored in the input data storage unit is changed.

That is, the test data totaling system of the present invention comprises an input data storage unit for storing input data, and a history storage unit for storing a history when data stored in the input data storage unit is changed. Have. For this reason, by leaving the change history of the input data, even if the input data needs to be changed for some reason, G
LP and the like can be guaranteed.

In the test data totaling system according to the present invention, when a protection means for protecting the history stored in the history storage unit from being unchangeable is provided, the history is protected from being changed. G
LP and the like can be reliably guaranteed.

In the test data totaling system of the present invention, when the quantity P for the first item A and the quantity Q for the second item B are present, the quantity P for the first item A is calculated by the second item In the case where a deemed counting means for counting and counting the number of items B is provided, for example, even if a plurality of observers measure the same item in different expressions, the number of items for the first item A By summing P assuming it as the quantity of the second matter B, a plurality of matters having different expressions are summed up as the same matter. Therefore,
The same items with different expressions are less likely to be treated as different data, and the tendency of the symptoms can be reliably caught, and changes in the symptoms are hardly overlooked, thereby greatly improving the objectivity of the data. In addition, the necessity of retesting to confirm the tendency of symptoms is significantly reduced, and the cost required for testing can be significantly reduced.

In the test data totaling system according to the present invention, the protection means for protecting the totalized result deemed by the deemed totaling means from being unchangeable, and the totaling result storage means for storing the totalized result protected by the protecting means are provided. If it is provided, the tally result is protected from being changed, so that the tallyed data is not falsified later and GLP or the like can be reliably guaranteed.

[0016] In the present invention, when a totaling condition input means for inputting the totalizing condition of the deemed totaling is provided, and the input totaling condition is stored in the totaling result storage means together with the totaling result, the totaling result is displayed together with the totaling result. Since the tally conditions are also stored, the tally results can be handled as formal data based on the GLP without changing the input so-called raw data.

In the test data summarizing system of the present invention, when finding data such as changes in the symptoms of a living body when a medicine is administered to a living body are to be summed up, the test for administering the medicine to the living body is as described above. Since strict standards such as GLP and GCP (standards for conducting clinical trials of pharmaceuticals) are defined, the effect of preventing the falsified data from being falsified later is remarkable and effective.

In the test data summarizing system of the present invention, when used for a toxicity test of a drug using an animal as a living body, the toxicity test of the drug using an animal as a living body is a huge and various data. Since the collection is necessary, and the expression of pathological findings by a plurality of observers tends to vary over a long period of time, the effect of the deemed aggregation is remarkable and effective.

In addition, in a long-term test, conventionally, the counting conditions and the criteria of the counting method may be changed during the testing period, so that the past data cannot be used and it is necessary to re-test. Although inconvenience has occurred, in the system of the present invention, even if the tallying condition or the standard of the tallying method is changed, past data can be used by performing deemed tallying.

Conventionally, data on the bias of symptom data (background data) generated for each facility, each building, each cage for breeding animals, etc., is also important data originally attached to the experimental results. regardless of,
Even though they were saved, they could not be tabulated due to differences in code system and tabulation method. In the system of the present invention, background data can be utilized by performing deemed totalization.

[0021]

Next, embodiments of the present invention will be described in detail.

FIG. 1 is a system configuration diagram showing an embodiment of a test data totaling system according to the present invention. This system is based on the weight, food,
Data input means (for example, keyboard, mouse, etc.) for inputting various data such as the amount of water and urine and various pathological findings.
And a data processing unit 1 that receives the data input to the data input unit 3 and performs data transfer and the like to each of a totaling unit, a storage unit, an output unit, and a display unit, which will be described later. . In the figure, reference numeral 13 denotes a storage device such as a hard disk or MO, and reference numeral 12 denotes a computer device including a central processing unit, a memory, and the like.

The system includes an output means (for example, a printer) 2 for outputting data and the like input by the data processing unit 1 to a form or the like, and various kinds of information at the time of data input and data output. A display unit (for example, a display or the like) 5 for displaying is provided. Further, an input data storage unit 4 for storing input so-called raw data via the data processing unit 1 is provided.

Here, in the above-mentioned system, normal data input is performed by each of the above-mentioned means. That is, the data input by the data input unit 3 is stored in the input data storage unit 4 via the data processing unit 1, and during the input operation, necessary information other than the input data is displayed on the display unit 5. It is displayed.

Further, the system is provided with a data change history storage section 8 for storing a data change history when data stored in the input data storage section 4 is changed. Further, the system is provided with a lock mechanism 10 for protecting the data change history from being unchangeable when storing the data change history in the data change history storage unit 8. Further, the same history data as the data change history data stored in the data change history storage unit 8 is stored in a computer device provided in another remote location (for example, a device installed in another department such as a quality assurance department). Is sent to

When the data change history protected by the lock mechanism 10 is read out from the data change history storage section 8, a predetermined password input screen is displayed, and the data cannot be read out without inputting the correct password. ing.
Also, it cannot be changed even after reading.

Further, the system receives the data stored in the input data storage unit 4 via the data processing unit 1, and converts not only the input original pathological finding but also a certain pathological finding into another pathological finding. A deemed counting means 6 is provided for counting the counts as pathological findings. Also,
A counting result storage unit 7 for storing the counting results counted by the deemed counting means 6 is provided.

Further, the system is provided with a tallying condition input unit 11 for inputting tallying conditions for the deemed tallying by the deemed tallying means 6 together with comments such as reasons for setting the tallying conditions. The storage unit 7 stores the total conditions (including comments on the total conditions) input to the total condition input unit 11 together with the total results obtained by the total conditions.

Further, the above system protects the totaling conditions for performing the deemed totaling, the comment on the totaling conditions, and the totalized result obtained by the deemed totaling in the above deemed totalized data storage unit 7 so that the data cannot be changed. The lock mechanism 9 is provided.

When reading out the tally result protected by the lock mechanism 9 from the tally result storage section 7, a predetermined password input screen is displayed, and the tally can not be read unless an accurate password is input. I have. Further, even after the reading, the counting result already deemed to be counted cannot be changed. The tabulation results and the like stored in the tabulation result storage unit 7 are displayed on the display unit 5 via the data processing unit 1 and output from the output unit 2 to a predetermined form or the like.

Next, the operation of the test data totaling system will be described with reference to the flowchart shown in FIG. In the figure, "S" means a step.

First, data such as the amount of body weight, food, water, urine and the like and observation findings of pathological symptoms when the medicine is actually administered to the animal are input to the data input means 3. At this time, as the observation findings of the pathological symptoms, for example, a certain observed symptom and a count number for the symptom are input (S
1). The data input here is stored in the input data storage unit 4 as needed (S2).

Next, when it is necessary to change the input data stored in the input data storage section 4 (S3), the data is changed as needed and the changed data is stored again in the input data storage section 4 (S3). ~ S4). At this time, the history data in which the data has been changed (how and what data has been changed) is locked by the lock mechanism 10 and then stored in the data change history storage unit 8 and transmitted to a computer device of another department. (S6).

As described above, by leaving the change history of the input data, even if the input data needs to be changed for some reason, the GLP or the like can be guaranteed.

Next, after the input data is changed or when there is no need to change the input data in step 3, the process proceeds to step 7. In step 7, the necessity of the deemed tally is examined, and if the deemed tally is not performed, the process ends. On the other hand, when there are a plurality of similar pathological findings that may be identified, any one of the plurality of pathological findings A, B, C,... Is selected, and the other findings B, C,. Is considered as the count of the one finding A, and the counting is performed.

That is, first, a totaling condition (data extraction condition and comment) is input to the totaling condition input unit 11 (S8). Then, deemed counting is started in accordance with the input counting condition (S9), and after the counting is completed, the counting result and the input counting condition are locked by the lock mechanism 9 (S1).
0), the tabulation result and the tabulation condition are stored in the tabulation result storage unit 7 (S11), and the tabulation result is printed on a predetermined form by the output unit 2 (S12).

As described above, according to the above-described system, even if a certain pathological finding is counted by different expressions among a plurality of observers, the count for a certain pathological finding is counted by the counting of another similar pathological finding. As a result, a plurality of pathological findings having different expressions are totaled as the same pathological finding. Therefore, similar pathological findings with different expressions are less likely to be treated as different data, and it is possible to reliably catch minute trends and rarely overlook changes in symptoms, greatly improving the objectivity of data . Further, the necessity of re-testing for confirming a slight tendency is greatly reduced, and the cost required for the test can be significantly reduced. In addition, since the tally result is protected from being changed, the tally data is not falsified later, and GLP or the like can be reliably guaranteed.

The above-described system is suitably used for compiling data such as changes in symptoms of a living body when a drug is administered to the living body. This is because, in a test in which a drug is administered to a living body, strict standards such as GLP and GCP are set, and the effect of preventing data that has been deemed and compiled from being falsified later is remarkable and effective. Further, the above system is suitably used for a toxicity test of a drug using an animal as a living body. The toxicity test of drugs using animals as living organisms requires huge and diverse data collection, and the expression of pathological findings by multiple observers is likely to vary. Because it is a target.

In the above embodiment, the medicine is not limited to a medicine, but includes various chemical substances including agricultural chemicals, food additives, and external preparations for skin.

Further, the system of the present invention is not limited to a toxicological test of a drug using an animal as a living body, but also a pharmacology test, a general pharmacology test, a pharmacodynamic test, or a pharmacodynamic test before entering an animal safety test. Can be applied to clinical tests and the like in which is administered to the human body. In addition, it can be applied to non-GLP tests. Even in these cases, the same operation and effect can be obtained.

[0041]

As described above, according to the test data totaling system of the present invention, GLP and the like are guaranteed even if the input data needs to be changed for some reason by leaving the change history of the input data. Will be able to

[Brief description of the drawings]

FIG. 1 is a system configuration diagram showing an embodiment of a test data totaling system according to the present invention.

FIG. 2 is a flowchart illustrating an operation of the test data totaling system.

[Explanation of symbols]

 3 Data input means 4 Input data storage unit 8 Data change history storage unit

Claims (8)

[Claims] 1. A test data totaling system for totalizing data obtained as a result of a test, comprising: a data input unit for inputting data; an input data storage unit for storing the input data; and an input data storage unit 1. A test data totaling system, comprising: a history storage unit for storing a history when data stored in the data is changed. 2. The test data totaling system according to claim 1, further comprising a protection unit for protecting a history stored in the history storage unit from being changed. 3. The test data totaling system according to claim 2, wherein the history protected so as not to be changed is transmitted to another computer device. 4. When there is a quantity P for the first item A and a quantity Q for the second item B, the quantity P for the first item A is regarded as the quantity of the second item B. The test data totaling system according to any one of claims 1 to 3, further comprising a deemed totalizing means for totalizing. 5. A tallying means for protecting a tallying result obtained by deeming tallying means so as not to be changed, and a tallying result storing means for storing the tallying result protected by the protecting means. Test data aggregation system. 6. The test data totaling system according to claim 5, further comprising a totaling condition input unit for inputting a totalizing condition of the deemed totaling, wherein the input totaling condition is stored together with the totaling result in a totaling result storage unit. 7. The test data totaling system according to claim 1, which totalizes finding data such as a change in symptoms of the living body when the drug is administered to the living body. 8. The test data totaling system according to claim 1, which is used for a toxicity test of a drug using an animal as a living body.