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: