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									                                Database Design
           CmpE 226              Practice Problems               Spring 2005
                                Practice Problem (6)
___________________________________________________________
This problem statement was developed by
Team name: "Aces"
Members: Advait Kothare, German Serrano, Vijay Tandel, Huy Ho
___________________________________________________________
                               Clinical Data Sharing
Abstract:
In this age of biotechnology, it is imperative to handle the great amount of research and
clinical data associated with the development and verification of medical devices and
medication. Because of this, the role of Clinical Research Organizations (CRO) has
become more important, as they act as consultants to help handle such information.
Currently CRO handles and distributes such information through telephone, fax, emails
or courier. The CROs also store all of this data on a paper-based file system. However,
this mode of data handling is not efficient in today’s environment, in which data has to be
available instantly, and stored efficiently. Because of this, a CRO offered the ACES
team to develop a web-based database system to handle their information and situation.

Description of Domains:
Based upon our understanding of the problem statement, the problem statement can be
broken down into three types of facilities/domains:
     A Clinical Research Organization (CRO)
     Customers to CRO (Pharmaceutical, Biotechnology and Medical Device
        Industries)
     Clinical Research Facilities (Hospitals and Universities)

     The role of the clinical research organization is to act as a consultant to its main
customers, who are derived from the pharmaceutical, biotechnology and medical device
industries. Their role is to help these industries to test their products through research.
Customers to CRO may not have the resources or direction to perform such research to
test their products. Because of this, companies within these industries look to CROs to
help navigate them to perform the necessary research to test their products before the
overall public uses them.
         Because CRO acts more as a consultant rather than a proper research facility,
CRO will consult with clinical sites, such as hospital or universities, to help them perform
the research that is needed to help the CRO helps their customers. Clinical sites will
perform the research needed, and return to the CRO the necessary data for analysis.

Description of Desired Solution:
       The CRO proposed to the ACES team a web-based database solution; the goal of
this web-based database solution is to help them handle the storage and transfer of
information efficiently through all three domains, which the current solution does not
offer. Functions of the web-based database include:
     All three domains will have permission to read, write, and modify the web-based
        database.
     The web-based database will also provide access security to the domain.

Use Cases and User Context:
The users of this system within all three domains will be:
   The CRO Domain:
    Consulting Team: The consulting team of the CRO is responsible for organizing
       the research asked of them by a certain industry customer. The consulting team
       will require the use of the web-based database in order for them to handle the data
       for their customer, and to use that information for their consultation.
    Database Operator: The database operator of the CRO is responsible for
       managing the web-based database. The database operator will require the use of
       the web-based database in order to add, remove, or modify any data in the
       database

   Clinical sites:
    Scientists: Scientists at the clinical sites are the ones who will perform the
       research required to verify a certain medical product. Scientists will require the
       use of the web-based database in order to view previous research data, or any
       other data that may be relevant to their research.
    Technicians: Technicians at the clinical sites are those who test the product and
       provide test results. The will require the use of the web-based database in order to
       record test results of specific products.
    Database Operator: The database operator at the clinical site, similar to the
       database operator at the CRO is responsible for managing the web-based
       database. The database operator will require the use of the web-based database in
       order to add, remove, or modify any data in the database.

   Industries:
    Product Manager: The project manager specifies their products capabilities,
      benefits, and particular users of a particular product that they would like research
      to done on. Project managers will need to utilize the web-based database in order
      to store their products information.
    Sales and marketing People: The sales and marketing people are the ones who
      will try to promote their health products. They may use the web-based database
      in order to collect data for their promotion.

Interfaces:
The interface for our system will be a web-browser, such as Internet Explorer, Netscape,
Mozilla, etc.

References:
www.clinimetrics.com

								
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