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System to support the clinical study at medical institution.
(Web-based system)
MedStar
Web-based system to support the Clinical Study
complying with GCP at Medical Institution
Global Pharma System Inc.
AIOS Gotanda Building 308,
1-10-7 Higashi Gotanda, Shinagawa-ku,
Tokyo, 141-0022,Japan
TEL: +81-(0)3-6450-4038
WebSite : http://www.g-pharma.co.jp/
■ The role and function of MedStar
■ MedStar supports the business procedures for the imple-
mentation of clinical study in the medical site.
･ MedStar covers necessary action items complying with GCP which should be
implemented during the clinical study period.
･ MedStar has a built-in check list which should be corresponded to all jobs to
be implemented.
･ Each medical site can set up the own unique check list for a medical site
apart from the built-in check list.
･ MedStar has all forms of the unification format (officially announced format).
･ The progress of the clinical study can be monitored electronically.
■ MedStar manages the schedule of a person who are
participated into the clinical study
･ Individual schedule is displayed by month.
･ Schedule of all members in the same organization are displayed by week.
･ The visiting schedule of the subject, the schedule of clinical examination, and
also the schedule of meeting, are displayed.
■ All medical institution which participate in the protocol can
use MedStar via the internet.
・The security is kept by strict administration of the access. MedStar
■ The sponsor of the clinical trial can monitor the integrated
study information in multi-center trial.
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■ The network of the clinical study by MedStar
MedStar is accessible from the medical institution, IRB, Sponsor,
SMO, CRO, and so on.
IRB
The initial screen menu for each access site
・CommonIRB
・CentralIRB
InterNet ・InternalIRB
MedStar
Medical institution／SMO Pharmaceutical company／CRO
■Monitoring by PC
SMC ■Monitoring by visit
(Administration)
Each organization can set the checklist individually.
SMC (Study Monitoring Center / tentative name) is
responsible for the system management, password
administration, and the entry of protocol information.
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■ Access to MedStar
Please obtain a set-up CD and a password first
Obtains the Participates
CD for in the clinical
setting-up. trial.
InterNet Obtains the
password
Medical Institution
MedStar Access to
MedStar
＜Log-in Window＞
Starts the
Similar procedure will be taken in case of the access daily work
from the IRB, or the sponsor of Clinical Study too.
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☆ Main menu of MedStar
"The schedule in today " is displayed in the screen left side, and the selection
buttons of the work item is displayed in the right.
Selectｓ the work item by button click
・Execution of the Clinical Study
complying with the GCP procedures.
・Administration of the hospital visit
schedule of the subject.
・Creation of the essential documents.
・Management of the schedule.
If there are any business schedules
such as patient‘s visit, or meeting
which should be done today, those
schedules are displayed automatically.
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☆ Click the button of Study Implementation
Implements the study according to the procedures.
click
MedStar manages the whole process of clinical study
complying with GCP procedures.
You are able to confirm the implementation process,
and manage the progress of the study.
You can enter the new data and revise it.
This screen with more detailed information
is displayed after clicking the block ①.
Detailed information
is displayed when
clicking a block ①.
①
Information from Information for Medical Information from IRB
Sponsor Site （see next page）
This "Study Implementation" button is very important in
MedStar to manage all procedure and the progress of
clinical trial together with the information about the
hospital visit of subject.
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⇒ The process management of the clinical study
More
info MedStar manages the whole process of the clinical study
complying with GCP.
The implementation process to be executed in the clinical study is
indicated in the screen of MedStar.
The curriculum vitae (CV)
The curriculum vitae (CV) Protocol Violation
Protocol Violation Change of sub invest. & cooperator
Change of sub invest. & cooperator
├CV of the principal Investigator └Drop out caused by protocol violation └ Change of sub investigator or
└CV of the sub Investigator └IRB process information cooperator.
Preparation prior to the study initiation
Preparation prior to the study initiation Information on the Drug Safety
Information on the Drug Safety Renewal of the Contract
Renewal of the Contract
├Investigation of Med. Site/Investigator └Receipt of the safety information └Renewal of the study contract
├Agreement on the Protocol └IRB process information
├Provides the doc. (for explanation & IC) Execution of the SDV
Execution of the SDV
Report of the study status (continue）
Report of the study status (continue）
├Designation of the investigators
└Acceptance of the monitoring for SDV
├The request of the clinical trial └Report of the study status
├IRB （Propriety of the implementation) └IRB process information
│ └First request of the study Study completion by principal invest.
Study completion by principal invest.
├Conclusion of the contract
Alteration of the study
Alteration of the study ├Withdrawal of study by principal invest.
└Startup meeting
├Suspends the study by principal invest.
└Receipt of the doc. on study change └Completion of study by principal invest.
Administration of the test drugs
Administration of the test drugs └IRB process information
Study completion by Sponsor
Study completion by Sponsor
Administration of the subjects
Administration of the subjects continuation of the clinical trial
continuation of the clinical trial ├Withdrawal of develop. by Sponsor.
├IRB exam.（continuity of the study） ├Withdrawal of study by Sponsor.
Serious ADEs
Serious ADEs │ ├Serious ADEs ├Suspends the study by Sponsor.
│ ├Protocol violation ├Approval of NDA by Sponsor.
└Reports on the serious ADEs └The notice of the reexamination and
│ ├Safety information
└IRB process information reevaluation result
│ ├Report on the study status
│ └Any changes of the study
└IRB evaluation (Others)
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☆ Click the button of Management of the subjects
Schedule of hospital visit, progress of the study, and the occurrence of
events (ADEs, drop out) are displayed.
The screen of detailed information appears by click ① or ②
click
① Checks the state of
hospital visit of subject
①
② ② Information on
the Protocol violation
Hospital visit schedule of subjects will be set up automatically
by MedStar utilizing the information of Protocol. ①
When clicking a button of hospital visit schedule of the subject,
the screen for a data entry to check the action on the date of
visit will appear. ①
If the important information on the subject such as serious
ADE or protocol violation was recorded, these information is
indicated.②
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☆ Click the button of Creation of Essential Documents
The document by the unification format can be created.
(supports any formats of clinical studies)
Example of the screen which is creating "serious ADE report"
click
Example which is creating
the report on "Serious ADE" ①
Serious ADE Report
All of the unification formats are included in this system.
Titles described on each button is varied by organization An example of the
or the types of trial. essential document
which was created
You can use the built-in format of MedStar to create the
essential documents in clinical trials such as the by click of ①
company trial, investigator initiated clinical study, and "Print" button
post-marketing clinical study.
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☆ Click the button of To-Do List
State of work completion is displayed by colored block
(yellow or blue).
click
Uncompleted work related
to the information of the
Click IRB examination is displayed.
When the check against the IRB
examination result notification is
uncompleted, the character is
displayed with the orange.
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⇒ Moreover, click the item of "not fixed yet " or "unchecked”
More
info The more detailed contents can be referred to about the non- check
and the uncompleted business.
[Example] : The notification of IRB examination ① (upper),
and the request of examination to IRB ② (bottom).
① Displays the list of action
items to check the completion
of the work
②
①
② Example of the entry screen
of "curriculum vitae" which has
not been fixed yet.
① Work progress is displayed by the figure of "finished
work / total work to be completed".
② Following information will be displayed.
－un-fixed documents (under drafting)
－un-received documents (the information which
has not been read yet)
② In case of the un-fixed
information, this message
will be displayed.
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☆ Click the button of Creation of Summary Table
Authorized person can create the summary table across the medical institution
by using registered 110 items.
click
These data can display as
a result of search by protocol
or by medical institution.
Select
You can register the type of summary table
as own dictionary. (below ; Example of list)
－State of the progress of IRB examination
－State of protocol violation and serious ADEs
－State of Study protocol under operation
After exporting the data which
－State of management of the test drugs is provided by above procedures,
－State of administration of the subject you can import these data to
Excel file and create the table.
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⇒ e-monitoring by the function of crossing total
More
info Utilizes as the powerful tool to support the daily monitoring
An example of the information which is possible to create
the summary table of medical institution
Category of Informmation Example as typical item to be summarized No. of items
1 Information before the study initiation Investigation on the medical site and investigator, etc. 14
２ Study Request / IRB investigation List of Sub investigator and cooperator, result of IRB 14
３ Information on the enrollment of subject No. of informed consent obtained, case of dropout, etc. 11
４ Information of protocol violation No. of cases with protocol violation, report date, etc. ４
５ Information of the evidence of serious ADE No. of ADE cases, date of occurrence, outcome, etc. 8
６ Information on the direct access (SDV) Date of inform, purpose, no. of cases, date of execution ４
７ Information of the renewal of contract No. of renewal, date, contract period, etc. 4
８ Information of administration of test drugs Lot no., drug name, custody information 7
９ Drug safety information No. of application, report date, outline of ADEs, etc. ４
１０ Information on the change of clinical trial No. of application, report date ２
１１ Information about the status of clinical trial No. of report, date, target case number, etc. 5
１２ Information on the renewal of contract No. of renewal, date, target case number, duration, etc. ４
１３ Study completion by primary investigator Reported date, target case number, study period, etc. ５
１４ Withdrawal of study by primary investigator Reported date, target case number, study period, etc. ５
１５ Suspend the study by primary investigator Reported date, target case number, study period, etc. ５
１６ Withdrawal of development by sponsor Reported date, study period ２
１７ Withdrawal of the study by sponsor Reported date, study period ２
１８ Suspend the study by sponsor Reported date, study period ２
１９ Info. on the approval of NDA by sponsor Reported date, study period ２
20 Info. on the reexamination or reevaluation Reported number, date, study period 3
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☆ Click the button of Schedule Table
Business support by various schedule information
click
The week schedule of
all users who belong to
this medical institution
The monthly schedule for
the person who is
accessing at present
① ②
Displays the contents of the
The monthly calendar of CRC who is accessing at present is displayed recorded meeting schedule
The week schedule of all the members of person in charge at the
medical site who are accessing at present is displayed
① Visiting schedule of the subject, ② plan of SDV, ② and also the
schedule of the meeting which was subscribed by the person in
charge, are displayed.
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☆ Click the button of Setting the basic information
Complicated linkage among the organization (medical institution, IRB,
and SMO) is available
click
The example of the screen to set the check list which is used
Information on the medical site and staffs at the medical site.
Set-up of the check lists
Linkage between medical institution SMO
Linkage between medical institution IRB
This button enable to establish the relation-
ship based on the mutual communication
among medical institution , IRB, Sponsor of
clinical trial, CRO, and SMO
It is possible to set the independent own
check list other than the list used to use at
the medical institution or IRB.
Built-in dictionary with about 200 check lists
which is necessary for the execution of the
clinical trial, is included as standard
equipment.
14 Global Pharma System Inc.
■ MedStar supports all types of clinical studｙ
MedStar supports to implement the clinical study complying with GCP
■ Following clinical studies are covered
・ Clinical trial which is operated by the company (pharmaceutical and medical device)
・ Investigator-initiated clinical studies/trials
・ Clinical study which is implemented after marketing
■ Because MedStar can be used under the Internet environment, initial
cost such as own server cost , or introductory fee, is unnecessary.
Only the fee for utilizing MedStar environment is requested.
・ The fee for use of MedStar in the medical institution is 50,000 yen/month/medical site.
・ The fee for use of MedStar by company/sponsor is 100,000 yen/month/protocol.
This includes the fee for browsing of detailed progress information and the fee for
using the function to create a summary table across the medical institutions.
・ The registration fee of the protocol information. (depends on the volume of information).
・ Implementation of registration of the protocol information is done based on the contract
with the study sponsor.
■ MedStar will contribute to increase the efficiency of the business.
・ It is possible to implement the clinical study by accessing to MedStar from all medical
sites which participate under one protocol.
・ By the combination with e-monitoring and usual monitoring, more effective monitoring
can be done for investigator-initiated clinical study.
・ It is possible to use for central monitoring in the local area clinical trial network.
・ It is possible to use MedStar as the business training kit for CRC.
15 Global Pharma System Inc.
■ Advantages to use MedStar
There are wide range of merits based on the function of
mutual communication.
● Advantages for medical institutions
■Information on the clinical trial can be managed at medical site
■GCP compliance and the clinical trial process control become easy
■Creation of an essential document using the unified format can be
facilitated
■Because the created document is saved as the electronic data, it can
search easily
■The information on the clinical trial can be accumulated and utilize
■Operation of the clinical trial by newly participated clinic will be easy
● Advantages for pharmaceutical companies
■The load of the CRC support by the monitor (CRA) will be reduced
■More efficient monitoring can be implemented using a combination
with visit monitoring and e-monitoring
■Because more efficient monitoring becomes possible by the electronic
monitoring, the entrusted protocol number can be increased
■Information on the clinical trial at the medical institution can search
and manage effectively
● Other merits to use this system
■This system covers the information issued by central IRB
■MedStar covers all forms of unified format of essential documents
■Applicable to various types of clinical studies
16 Global Pharma System Inc.
■ Utilizing MedStar to the Study in Clinical Network
An example of the clinical study network by MedStar
hospital A hospital B hospital C hospital D hospital E
SMO／Head Office
●Grasps the detailed current
status of clinical study
●Management of the study progress Study Monitoring Center
●Supports the work of clinical study ●password issue
in medical site ●subscribes the protocol
MedStar information
Sponsor / CRO
● Request of the clinical trial
● Grasp of the study progress
● Support of CRC activities
Secretariate of the network Secretariate of IRB
●Reception of the clinical trial ●Management of IRB information
●Information on the medical sites ●Creation of the report on the result
●Management of the study progress of IRB examination.
●Creation of the essential documents ●Paperworks on the IRB examination
The information which can be accessed is strictly managed by organization code (medical institution, clinical
trial secretariat, or IRB) which the user belongs to, and the permitted access right to the information.
17 Global Pharma System Inc.
■ Utilizing for the Investigator Initiated Clinical Study
An example of the network by MedStar for the investigator
initiated clinical study
Medical Institution
InterNet
Central IRB
MedStar
Common IRB
Chair person / Physician Study Monitoring Center
(tentative)
Monitoring by Visit Communication e-Monitoring
Monitor
●GCP compliance
■Visits the medical institution ●Current status of clinical trials
■Creates the Monitoring Report ●Monitors the occurrence and
■One monitor manages several handling of ADEs
medical sites ●Detection of urgent response
■The communication with SMC matters, and reporting
●Creation of the e-monitorting report
Periodical e-Monitoring Report
18 Global Pharma System Inc.
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