Download Clinical Data Sharing

Software System Engineering
CmpE 202
Practice Problems
Practice Problem (12)
Clinical Data Sharing
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Read the following problem statement and perform the following:
1. Use Case Diagrams and Use Cases. Use one or more diagrams to describe all the actors in
design session problem and how they will interact with the Use Cases of your system.
Provide Flow of Events for all of your Use Cases. Use associations, aggregations, and
generalization in the use case diagram(s) and don’t forget to use multiplicities. Use case
diagram(s) textual description is a must. Use the following template to document your use
cases.
1. Use Case Id.
2. Use Case Title
3. Actors & Corresponding Roles
4. Corresponding Classes
5. Corresponding Attributes
6. Corresponding Interfaces
(7. Class Classification: EBTs, Business Objects, and Industrial Objects for software
stability model)
8. Use Case Description
9. Alternatives
Evaluation: Use the model essentials to evaluate the use case models.
2. Document all the CRC cards for all the (classes) classes in the design session problems (CRC
stands for Class Responsibility and Collaborations)
Class Name (Role)
Collaborations
Responsibility
Clients
Servers
Evaluation: Use the model essentials to evaluate the CRC cards.
3. Class diagram (Traditional Model). Create a class diagram of the design session
problems based on the Traditional Model. Class diagram should include all attributes
and methods for the class. All class relationships (associations, aggregations,
dependencies, and specializations) should be included in the class diagram.
Association classes, interface classes, constraints, interfaces, tagged values and/or
stereotypes, and notes must be included in the class diagram.
Evaluation: Use the model essentials to evaluate the class diagram (Traditional).
4. Sequence diagrams. Sequence diagrams will be used to "realize" Use Cases. All Use
cases should be described through sequence diagrams. The sequence diagrams can
describe the same Use Cases that a flow of events was created for in the Use Case
portion of the assignment.
Evaluation: Use the model essentials to evaluate the sequence diagrams.
5. Activity Diagram. Activity diagram is similar to procedural flow charts except that
all activities are uniquely associated with objects. Activity diagrams support the
description of parallel activities. Activity diagrams: (a) Describes how activities are
coordinated; (b) Is particularly useful when you know that an operation has to achieve
a number of different things, and you want to model what the essential dependencies
between them are, before you decide in what order to do them; (c) Records the
dependencies between activities, such as which things can happen in parallel and
what must be finished before something else can start; and (4) Represents the
workflow of the process. Activities, transitions, decision diamond, constraints,
synchronization and splitting bars, boundaries, and start & stop markers must be
included in the class diagram.
Evaluation: Use the model essentials to evaluate the Activity diagrams.
Iterate: Redo 1, 2, 5, and 6 with stability in mind where:
Class diagram (Stability Model). Create a new Class diagram of the design session problems
based on the EBTs, BOs, and IOs. Class model should include all attributes and methods for the
class. All class relationships (associations, aggregations, dependencies, and specializations)
should be included in the Class diagram. Association classes, interface classes, constraints,
interfaces, tagged values and/or stereotypes, and notes must be included in the class diagram.
Evaluation: Use the model essentials to evaluate the class diagram (Stability Model).
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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 webbased 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