JP2005128927A - Program, method, and apparatus for supporting clinical trial - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To increase the efficiency of a clinical trial and to increase the reliability of a clinical trial result. <P>SOLUTION: The clinical trial includes steps of: reading the examinee information of a clinical trial procedure and the information of clinical trial action (e.g. dosing with a capsule A) out of an examinee IC card 10 that an examinee carries; reading dosage information out of an IC tag 21 attached to a medicine (capsule A) that the examinee should be dosed with; and registering the examinee information and dosage information in a clinical trial information database 64 through a wireless terminal 40 and a network 50. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a clinical test support program, a clinical test support method, and a clinical test support device that are suitable for use in support of clinical trials. In particular, the present invention can increase the efficiency of clinical trials and improve the reliability of clinical trial results. The present invention relates to a clinical test support program, a clinical test support method, and a clinical test support device.

  Conventionally, it is indispensable to conduct clinical trials to obtain case data by administering to subjects in actual clinical practice in order to apply for pharmaceutical import / manufacturing approval. For example, when sales of a new drug are planned, an appropriate clinical trial implementation plan is first formulated, and clinical trials are conducted on many subjects according to this clinical trial implementation plan with multiple medical institutions as clinical trial sites. Request.

  Specifically, in clinical trials, patients with specific symptoms are taken as subjects according to the efficacy of the drug being tested, and dosage and frequency are adjusted according to the severity, physique, age, etc. of the patient's symptoms. Is done. The doctor in charge fills in the clinical trial information entry form on paper with clinical name information such as the subject's disease name, age, gender, medication history, and examination. Thereafter, the clinical trial information entered in the clinical trial information entry form is manually input to the computer and managed.

JP 2002-215936 A

  However, conventional clinical trials use a technique in which clinical trial information is entered on a paper clinical trial information entry form and then entered into a computer, which is inefficient in carrying out clinical trials and human error. There is a possibility that erroneous entry or input may occur, which may adversely affect the reliability of clinical trial results.

  The present invention has been made in view of the above, and can improve the efficiency of clinical trials and can improve the reliability of clinical trial results, a clinical trial support program, a clinical trial support method, and a clinical test support apparatus The purpose is to provide.

  In order to solve the above-described problems and achieve the object, the present invention provides a computer with a first read step of reading information on clinical trial actions in a clinical trial procedure from a subject IC card carried by the subject during a clinical trial. And a second reading step for reading medication information from an IC tag attached to a drug to be administered to the subject based on the clinical trial action, and a registration step for registering the medication information. It is a clinical trial support program.

  According to the present invention, in clinical trials, information on clinical trial actions in the clinical trial procedure is read from the subject IC card carried by the subject, and from the IC tag attached to the drug to be administered to the subject based on the clinical trial actions. Since we decided to lead the medication information and register the medication information, the automatic registration of the medication information can avoid the conventional mistakes and input errors, improve the efficiency of clinical trials and improve the reliability of clinical trial results. it can.

  Further, the present invention is the above invention, wherein in the first lead step, subject information is read from the subject IC card in addition to the clinical test action information, and in the registration step, the medication information is added in addition to the medication information. The subject information is registered.

  According to this invention, the subject information is read from the subject IC card in addition to the clinical trial action information, and the subject information is registered in addition to the medication information. Incorrect entry and input can be avoided, and the efficiency of clinical trials can be improved and the reliability of clinical trial results can be improved.

  In the invention described above, the computer may cause the computer to execute a writing step of writing information on a next clinical trial action in the clinical trial procedure to the subject IC card after the clinical trial action is completed. Features.

  According to the present invention, after the clinical trial action is completed, information on the next clinical trial action in the clinical trial procedure is written to the subject IC card, so that an error in the clinical trial procedure can be avoided.

  Moreover, the present invention is characterized in that, in the above-mentioned invention, in the writing step, medication history information is written to the subject IC card.

  According to the present invention, since the medication history information is written to the subject IC card, the medication history can be referred to as needed by the subject IC card.

  Further, the present invention is characterized in that, in the above-mentioned invention, the computer is caused to execute a check step for checking validity of the clinical test action.

  According to the present invention, since the validity of the clinical trial action is checked, the reliability of the clinical trial procedure can be improved.

  Also, the present invention should be administered to the subject based on the first lead step for reading the clinical trial action information in the clinical trial procedure from the subject IC card carried by the subject during the clinical trial, and the clinical trial action. The method includes a second reading step of reading medication information from an IC tag attached to the medicine, and a registration step of registering the medication information.

  According to the present invention, in clinical trials, information on clinical trial actions in the clinical trial procedure is read from the subject IC card carried by the subject, and from the IC tag attached to the drug to be administered to the subject based on the clinical trial actions. Since we decided to lead the medication information and register the medication information, the automatic registration of the medication information can avoid the conventional mistakes and input errors, improve the efficiency of clinical trials and improve the reliability of clinical trial results. it can.

  Further, the present invention is the above invention, wherein in the first lead step, subject information is read from the subject IC card in addition to the clinical test action information, and in the registration step, the medication information is added in addition to the medication information. The subject information is registered.

  According to this invention, the subject information is read from the subject IC card in addition to the clinical trial action information, and the subject information is registered in addition to the medication information. Incorrect entry and input can be avoided, and the efficiency of clinical trials can be improved and the reliability of clinical trial results can be improved.

  Further, the present invention is characterized in that, in the above-described invention, after the clinical trial action is completed, a write process is performed to write information on a next clinical trial action in the clinical trial procedure to the subject IC card.

  According to the present invention, after the clinical trial action is completed, information on the next clinical trial action in the clinical trial procedure is written to the subject IC card, so that an error in the clinical trial procedure can be avoided.

  Moreover, the present invention is characterized in that, in the above-mentioned invention, in the writing step, medication history information is written to the subject IC card.

  According to the present invention, since the medication history information is written to the subject IC card, the medication history can be referred to as needed by the subject IC card.

  Further, the present invention is characterized in that, in the above-mentioned invention, a check step for checking validity of the clinical trial action is included.

  According to the present invention, since the validity of the clinical trial action is checked, the reliability of the clinical trial procedure can be improved.

  Further, according to the present invention, in the clinical trial, the first lead means for reading the clinical trial action information in the clinical trial procedure from the subject IC card carried by the subject, and the subject should be administered based on the clinical trial action A second reading means for reading medication information from an IC tag attached to the medicine, and a registration means for registering the medication information are provided.

  According to the present invention, in clinical trials, information on clinical trial actions in the clinical trial procedure is read from the subject IC card carried by the subject, and from the IC tag attached to the drug to be administered to the subject based on the clinical trial actions. Since we decided to lead the medication information and register the medication information, the automatic registration of the medication information can avoid the conventional mistakes and input errors, improve the efficiency of clinical trials and improve the reliability of clinical trial results. it can.

  Further, the present invention is the above invention, wherein the first reading means reads subject information from the subject IC card in addition to the clinical trial action information, and the registration means includes the medication information in addition to the medication information. The subject information is registered.

  According to this invention, the subject information is read from the subject IC card in addition to the clinical trial action information, and the subject information is registered in addition to the medication information. Incorrect entry and input can be avoided, and the efficiency of clinical trials can be improved and the reliability of clinical trial results can be improved.

  Further, the present invention is characterized in that, in the above-mentioned invention, after the clinical test action is completed, a writing means is provided for writing information on a next clinical test action in the clinical test procedure to the subject IC card.

  According to the present invention, after the clinical trial action is completed, information on the next clinical trial action in the clinical trial procedure is written to the subject IC card, so that an error in the clinical trial procedure can be avoided.

  Further, the present invention is characterized in that, in the above-mentioned invention, the writing means writes medication history information to the subject IC card.

  According to the present invention, since the medication history information is written to the subject IC card, the medication history can be referred to as needed by the subject IC card.

  Further, the present invention is characterized in that in the above invention, a check means for checking validity of the clinical test action is provided.

  According to the present invention, since the validity of the clinical trial action is checked, the reliability of the clinical trial procedure can be improved.

  According to the present invention, in clinical trials, information on clinical trial actions in a clinical trial procedure is read from a subject IC card carried by the subject, and from an IC tag attached to a drug to be administered to the subject based on the clinical trial actions. Since we decided to lead the medication information and register the medication information, the automatic registration of the medication information can avoid the conventional mistakes and input errors, improve the efficiency of clinical trials and improve the reliability of clinical trial results. There is an effect that can be done.

  In addition, according to the present invention, the subject information is read from the subject IC card in addition to the clinical trial action information, and the subject information is registered in addition to the medication information. Conventional erroneous entry and input are avoided, and further, the efficiency of clinical trials can be improved and the reliability of clinical trial results can be enhanced.

  In addition, according to the present invention, after the clinical trial action is completed, information on the next clinical trial action in the clinical trial procedure is written to the subject IC card, so that an error in the clinical trial procedure can be avoided. There is an effect.

  Further, according to the present invention, since the medication history information is written to the subject IC card, the medication history can be referred to as needed by the subject IC card.

  In addition, according to the present invention, since the validity of the clinical trial action is checked, the reliability of the clinical trial procedure can be improved.

  Hereinafter, an embodiment of a clinical test support program, a clinical test support method, and a clinical test support device according to the present invention will be described in detail with reference to the drawings. The present invention is not limited to the embodiment.

  FIG. 1 is a block diagram showing the configuration of an embodiment according to the present invention. FIG. 1 shows a clinical test support system that is provided in a medical institution that performs the above-described clinical test and is used to support the clinical test.

  In this clinical test support system, a subject IC (Integrated Circuit) card 10 is an IC card that can read / write information in a non-contact manner by electromagnetic coupling with a reader / writer 35 described later, and is carried by the subject. The subject IC card 10 includes an antenna 11, an IC 12, and a memory 13 embedded in a card base material. The antenna 11, the IC 12, and the memory 13 are IC tags called RFID (Radio Frequency IDentififation). In other words, the subject IC card 10 is a card with an IC tag.

  The antenna 11 supplies an electromotive force generated by being placed in an induction electromagnetic field from the reader / writer 35 to the IC 12 and the memory 13. The IC 12 controls reading and writing with respect to the memory 13. The memory 13 stores information such as a subject ID, disease name, subject name, age, sex, height, weight, next clinical trial action, medication history, and the like. The subject ID is an identifier for identifying the subject. The disease name, subject name, age, sex, height, and weight are subject information about the subject.

  The next clinical trial action represents the clinical trial action to be performed next time in the clinical trial procedure (procedure for performing the clinical trial). For example, as shown in FIG. 3, the clinical trial procedure is composed of three actions, clinical trial action 1 (dosing A capsule), clinical trial action 2 (dosing B capsule), and clinical trial action 3 (examination X). If clinical trial action 1 (dosing A capsule) has been performed this time, the next clinical trial action is clinical trial action 2 (dosing B capsule).

  The medication 20 shown in FIG. 1 is dosed to a subject based on clinical trial action. The IC tag 21 is attached to the medicine 20 and includes an antenna, an IC, and a memory in the same manner as the subject IC card 10. The memory of the IC tag 21 stores medication information related to the medication 20 such as a medicine name, active ingredient, dosage, and dosage method. The medication information is read from the IC tag 21 by the reader / writer 35 in a non-contact manner.

  In an actual clinical trial site, since a plurality of types of drugs are used for a plurality of subjects, a plurality of subject IC cards 10 are carried by each subject, and a plurality of drugs 20 and IC tags 21 exist. To do.

  The clinical trial support apparatus 30 supports clinical trials by reading / writing the subject IC card 10, reading the IC tag 21, automatic setting (input) of clinical trial information (subject information, medication information, etc.), etc. These devices are PDA (Personal Digital Assistant) and personal computer devices (desktop type, notebook type).

  The clinical test support device 30 is operated by a doctor, an assistant, or the like, and is connected to the clinical test management device 60 via the wireless terminal 40 and the network 50.

  In the clinical trial support apparatus 30, the control unit 31 controls each part of the apparatus. Details of the operation of the control unit 31 will be described later. The storage unit 32 stores computer programs and various information used by the control unit 31. The display unit 33 is an LCD (Liquid Crystal Display) or a CRT (Cathode Ray Tube), and displays various screens (see FIGS. 6 to 9) described later.

  The input unit 34 is a keyboard or a mouse. The reader / writer 35 has a function of reading / writing various information with respect to the subject IC card 10 and reading various information from the IC tag 21 in a non-contact manner. The wireless communication unit 36 is connected to the wireless terminal 40 via a wireless line, and controls wireless communication according to a predetermined communication protocol.

  The wireless terminal 40 is provided in the vicinity of the clinical test support device 30 and performs wireless transmission / reception. The network 50 is a local area network laid in the medical institution, an external Internet, or the like.

  The clinical test management device 60 is a device for managing clinical test information and clinical test procedure information. In the clinical trial management device 60, the control unit 61 controls each part of the device. Details of the operation of the controller 61 will be described later. The storage unit 62 stores computer programs and various information used by the control unit 61. The communication unit 63 is connected to the network 50 and controls communication according to a predetermined communication protocol.

  The clinical trial information database 64 is a database that stores clinical trial information. Specifically, as shown in FIG. 2, the clinical trial information database 64 includes “registration date”, “subject ID”, “disease name”, “subject name”, “age”, “sex”, “ Stores clinical trial information including height, weight, doctor in charge, clinical trial action 1, drug name, active ingredient, dosage, and dosage method.

  “Registration date” is information relating to the date when clinical trial information is registered in the clinical trial information database 64. The “subject ID”, “disease name”, “subject name”, “age”, “sex”, “height”, and “weight” are information read from the subject IC card 10. The “in-charge doctor” is information regarding the name of the doctor in charge of the clinical trial.

  “Clinical trial action 1” is information regarding the clinical trial action described above. “Drug name”, “Active ingredient”, “Dosage” and “Dosage method” are dosing information regarding dosing based on clinical trial action 1 (eg, A capsule is dispensed).

  Returning to FIG. 1, the clinical trial procedure information database 65 is a database that stores clinical trial procedure information representing a clinical trial procedure. Specifically, the clinical trial procedure information database 65 includes, as shown in FIG. 3, “disease name”, “clinical trial action 1”, “clinical trial action 2”, “clinical trial action 3”,. The clinical trial procedure information consisting of is stored.

  “Disease name” is information relating to a disease name which is a key of a clinical trial. “Clinical Trial Action 1”, “Clinical Trial Action 2”, “Clinical Trial Action 3”, etc. are information representing specific procedures of the clinical trial.

  Next, the operation of one embodiment will be described with reference to FIGS. FIG. 4 is a flowchart for explaining the operation of the embodiment. FIG. 5 is a flowchart for explaining the clinical test action process shown in FIG. Hereinafter, a case where Kenichi Sato (doctor in charge) conducts a clinical trial on Taro Yamada (subject) will be described.

  In step SA1 shown in FIG. 4, the control unit 31 of the clinical trial support apparatus 30 determines whether or not the card information (subject ID, disease name,..., Next clinical trial action, etc.) has been read from the subject IC card 10. In this case, the determination result is “No”, and the same determination is repeated.

  On the other hand, in step SB1 shown in FIG. 4, the control unit 61 of the clinical test management device 60 determines whether or not clinical test information has been received from the clinical test support device 30, and in this case, the determination result is “No”. The same judgment is repeated.

  Here, the initial screen 70 shown in FIG. 6 is displayed on the display unit 33 of the clinical trial support apparatus 30. This initial screen 70 is a screen for instructing the doctor in charge to hold the subject IC card over the reader / writer 35.

  Then, in order of Taro Yamada (subject), Kenichi Sato (doctor in charge) receives the subject IC card 10 from Taro Yamada (subject) and brings it closer to the reader / writer 35. As a result, the reader / writer 35 reads card information (subject ID, disease name,..., Next clinical test action, etc.) from the subject IC card 10 (memory 13). Thereby, the control part 31 makes the judgment result of step SA1 "Yes." Here, it is assumed that the next clinical trial action is clinical trial action 1 (medication A capsule) as an initial setting.

  In step SA2, the control unit 31 confirms the next clinical trial action from the card information read by the reader / writer 35. In this case, the control unit 31 confirms clinical trial action 1 (A capsule is dispensed).

  In step SA3, the control unit 31 executes clinical test action processing corresponding to the clinical test action confirmed in step SA2 (in this case, clinical test action 1). Specifically, in step SC <b> 1 shown in FIG. 5, the control unit 31 causes the display unit 33 to display the subject information setting screen 71 shown in FIG. 7. This subject information setting screen 71 is a screen for setting subject information (subject ID, disease name, subject name, age, gender, height, weight, doctor in charge, etc.).

  In step SC <b> 2, the control unit 31 automatically sets the subject information included in the card information read from the subject IC card 10 in the subject information setting field 71 a of the subject information setting screen 71. In the field of the doctor in charge, “Kenichi Sato” is set as a default.

  In step SC3, the control unit 31 causes the display unit 33 to display the medication information setting screen 72 shown in FIG. On the medication information setting screen 72, a medication information setting field 72a for automatically setting medication information corresponding to the clinical trial action 1 (medication A capsule) and a medicine 20 (IC tag 21) which is an A capsule are read / read. A message for causing the writer 35 to read and a send button 72b are displayed.

  In step SC4, the control unit 31 determines whether or not the IC tag 21 is read by the reader / writer 35. In this case, the determination result is “No” and the same determination is repeated. Then, Kenichi Sato (the doctor in charge) holds the medicine 20 (IC tag 21), which is an A capsule, over the reader / writer 35 based on the message on the medication information setting screen 72.

  The reader / writer 35 reads medication information (medicine name, active ingredient, dosage, medication method, etc.) from the IC tag 21. Thereby, the control part 31 makes the judgment result of step SC4 "Yes." In step SC5, the control unit 31 automatically sets the read medication information in the medication information setting field 72a of the medication information setting screen 72.

  In step SA4 shown in FIG. 4, the control unit 31 determines whether or not the transmission button 72b of the medication information setting screen 72 has been pressed. In this case, the determination result is “No” and the same determination is repeated. When the transmission button 72b is pressed by Kenichi Sato (the doctor in charge), the control unit 31 sets “Yes” as a result of the determination made at step SA4.

  In step SA5, the control unit 31 displays the subject information automatically set on the subject information setting screen 71 (see FIG. 7) and the medication information automatically set on the medication information setting screen 72 (see FIG. 8) as clinical trial information. To the clinical trial management device 60. In step SA6, the control unit 31 determines whether or not the next clinical test action is notified from the clinical test management device 60. In this case, the determination result is “No” and the determination is repeated.

  When the clinical trial information is received, the control unit 61 of the clinical trial management device 60 sets “Yes” as a result of the determination made at step SB1. In step SB2, the control unit 61 registers the received clinical trial information (however, the registration date is automatically registered) in the clinical trial information database 64 (see FIG. 2).

  In step SB3, the control unit 61 uses the disease name and clinical trial action 1 included in the clinical trial information as keys, and the next clinical trial action (in this case, clinical trial action 2) from the clinical trial procedure information database 65 (see FIG. 3). (Capsule B is dispensed)) is searched.

  In step SB4, the control unit 61 notifies the clinical trial support apparatus 30 of the next clinical trial action (in this case, clinical trial action 2 (medicate capsule B)). Accordingly, the control unit 31 of the clinical trial support apparatus 30 sets “Yes” as a result of the determination made at step SA6.

  In step SA7, the control unit 31 causes the Kenichi Sato (doctor in charge) to confirm the notified next clinical trial action (in this case, clinical trial action 2 (medical capsule B)), and a clinical trial action confirmation screen 73 ( 9) is displayed on the display unit 33.

  In step SA8, the control unit 31 writes information for writing information on the next clinical trial action and medication history (in this case, medication of capsule A corresponding to clinical trial action 1) into the subject IC card 10 (memory 13). It is determined whether or not the button 73a has been pressed. In this case, the determination result is “No” and the determination is repeated.

  Then, when the writing button 73a is pressed by Kenichi Sato (doctor in charge) who has confirmed the next clinical trial action (in this case, clinical trial action 2 (medicine capsule B)), the control unit 31 performs step SA8. The determination result is “Yes”. In step SA9, the control unit 31 sends the information about the next clinical trial action (in this case, clinical trial action 2 (medicate capsule B)) and medication history via the reader / writer 35 to the subject IC card 10 (memory 13). ).

  In step SA1, the control unit 31 of the clinical trial support apparatus 30 determines whether or not the card information is read from the subject IC card 10. In this case, the determination result is “No” and the determination is repeated.

  Then, after a few days (next time), in the order of Taro Yamada (subject), Kenichi Sato (doctor in charge) receives the subject IC card 10 from Taro Yamada (subject) and brings it closer to the reader / writer 35. As a result, the reader / writer 35 reads card information (subject ID, disease name,..., Next clinical test action, etc.) from the subject IC card 10 (memory 13). Here, the next clinical trial action is clinical trial action 2 (dosing B capsule).

  In step SA2, the control unit 31 confirms the clinical test action (clinical test action 2) from the card information read by the reader / writer 35. Thereafter, for the clinical trial action 2, the same processing as described above is executed.

  In one embodiment, the card information of the subject IC card 10 is appropriately read to display the medication history on the display unit 33, and Kenichi Sato (doctor in charge) refers to the medication history as necessary. As an example.

  In one embodiment, the clinical trial management device 60 is inquired about the validity of the clinical trial action confirmed in step SA2 shown in FIG. 4, and only when the clinical trial action is notified that the clinical trial action is valid, the clinical trial action in step SA3. It is good also as a structural example which performs a process.

  In the embodiment, the configuration example in which the clinical test support device 30 and the clinical test management device 60 are separately provided has been described. However, the configuration may be integrated as one clinical test support device.

  As described above, according to one embodiment, in clinical trials, information on clinical trial actions (for example, administration of A capsules) in the clinical trial procedure is read by the reader / writer 35 from the subject IC card 10 carried by the subject. After that, based on the clinical trial action, the medication information is read by the reader / writer 35 from the IC tag 21 attached to the medicine 20 to be administered to the subject, and the medication information is registered in the clinical trial information database 64. By automatically registering medication information, conventional erroneous entry and input can be avoided, the efficiency of clinical trials can be improved, and the reliability of clinical trial results can be enhanced.

  Also, according to one embodiment, the subject information is read from the subject IC card 10 in addition to the clinical trial action information, and the subject information is registered in the clinical trial information database 64 in addition to the medication information. By automatically registering information and subject information, conventional erroneous entry and erroneous input can be avoided, and further, the efficiency of clinical trials can be improved and the reliability of clinical trial results can be enhanced.

  According to one embodiment, after the clinical trial action is completed, information on the next clinical trial action in the clinical trial procedure is written to the subject IC card 10, so that an error in the clinical trial procedure is avoided. Can do.

  In addition, according to one embodiment, since the medication history information is written to the subject IC card 10, the medication history can be referred to by the subject IC card 10 at any time.

  Further, according to one embodiment, since the validity of the clinical trial action is checked, the reliability of the clinical trial procedure can be improved.

  Although one embodiment according to the present invention has been described in detail with reference to the drawings, a specific configuration example is not limited to this one embodiment, and design changes and the like within a scope not departing from the gist of the present invention are possible. Even if it exists, it is included in this invention.

  For example, in the above-described embodiment, a program for realizing the functions of the clinical test support device 30 and the clinical test management device 60 is recorded on the computer-readable recording medium 200 shown in FIG. Each function may be realized by causing the computer 100 shown in FIG.

  A computer 100 shown in FIG. 1 includes a CPU (Central Processing Unit) 110 that executes the above-described program, an input device 120 such as a keyboard and a mouse, a ROM (Read Only Memory) 130 that stores various data, an operation parameter, and the like. RAM (Random Access Memory) 140, a reading device 150 for reading a program from the recording medium 200, and an output device 160 such as a display and a printer.

  The CPU 110 implements the above-described functions by reading a program recorded on the recording medium 200 via the reading device 150 and then executing the program. Examples of the recording medium 200 include an optical disk, a flexible disk, and a hard disk.

  As described above, the clinical trial support program, the clinical trial support method, and the clinical trial support apparatus according to the present invention are useful for the support of clinical trials, and in particular, the efficiency of clinical trials and the reliability of clinical trial results are improved. Suitable for improvement.

It is a block diagram which shows the structure of one Example concerning this invention. It is a figure which shows the clinical trial information database 64 shown in FIG. It is a figure which shows the clinical test procedure information database 65 shown in FIG. It is a flowchart explaining operation | movement of the same Example. It is a flowchart explaining the clinical test action process shown in FIG. It is a figure which shows the initial screen 70 in the same Example. It is a figure which shows the test subject information setting screen 71 in the same Example. It is a figure which shows the medication information setting screen 72 in the same Example. It is a figure which shows the clinical trial action confirmation screen 73 in the same Example. It is a block diagram which shows the structure of the modification of the same Example.

Explanation of symbols

10 Subject IC Card 20 Medicine 21 IC Tag 30 Clinical Trial Support Device 31 Control Unit 35 Reader / Writer 60 Clinical Trial Management Device 61 Control Unit

Claims (15)

On the computer,
A first lead process for reading clinical trial action information in a clinical trial procedure from a subject IC card carried by the subject during the clinical trial;
A second lead step of reading medication information from an IC tag attached to the medication to be administered to the subject based on the clinical trial action;
A registration step of registering the medication information;
Clinical trial support program to run   In the first lead step, subject information is read from the subject IC card in addition to the clinical trial action information, and in the registration step, the subject information is registered in addition to the medication information. The clinical trial support program according to claim 1.   3. The computer is caused to execute a write step of writing information on a next clinical trial action in the clinical trial procedure to the subject IC card after the clinical trial action is completed. Clinical trial support program.   4. The clinical trial support program according to claim 3, wherein in the writing step, medication history information is written to the subject IC card.   The clinical test support program according to any one of claims 1 to 4, wherein the computer is caused to execute a check step of checking validity of the clinical test action. A first lead process for reading clinical trial action information in a clinical trial procedure from a subject IC card carried by the subject during the clinical trial;
A second lead step of reading medication information from an IC tag attached to the medication to be administered to the subject based on the clinical trial action;
A registration step of registering the medication information;
A clinical trial support method comprising:   In the first lead step, subject information is read from the subject IC card in addition to the clinical trial action information, and in the registration step, the subject information is registered in addition to the medication information. The clinical trial support method according to claim 6.   8. The clinical test support method according to claim 6, further comprising a write step of writing information on a next clinical test action in the clinical test procedure to the subject IC card after the clinical test action is completed. .   9. The clinical test support method according to claim 8, wherein in the writing step, medication history information is written to the subject IC card.   The clinical test support method according to claim 6, further comprising a check step of checking validity of the clinical test action. A first lead means for reading clinical trial action information in a clinical trial procedure from a subject IC card carried by the subject during a clinical trial;
Second reading means for reading medication information from an IC tag attached to a drug to be administered to the subject based on the clinical trial action;
Registration means for registering the medication information;
A clinical trial support apparatus characterized by comprising:   The first read means reads subject information in addition to the clinical trial action information from the subject IC card, and the registration means registers the subject information in addition to the medication information. The clinical test support device according to claim 11.   13. The clinical trial support according to claim 11 or 12, further comprising a writing unit that writes information on a next clinical trial action in the clinical trial procedure to the subject IC card after the clinical trial action is completed. apparatus.   The clinical test support apparatus according to claim 13, wherein the writing means writes medication history information to the subject IC card.   The clinical test support apparatus according to claim 11, further comprising a check unit that checks the validity of the clinical test action.

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