Project Description

The University of Minnesota, Masonic Cancer Center (MCC), must conduct internal monitoring of all local,
investigator initiated cancer clinical trials that have patients enrolled.  The Clinical Trials Monitoring
Project (CTMP) team aimed to develop a user-friendly interface that the clinical monitors will use for
their day-to-day trial monitoring activities.


Responsibilities of monitors include:
- review regulatory and subject binders
- record what was monitored and if there were any findings to report
- search existing records
- produce a monitoring report which is submitted to a principal investigator so that any findings can be resolved


The purpose of the interface is then to provide means for such activities as recording when and how findings are resolved.
Once data has accumulated sufficiently, a lead monitor will regularly use the interface to produce trending reports.
The uses relevant to the CTMP include:
- searching for existing data
- entering new data
- producing a monitoring report


These are all tasks that a clinical monitor would perform during a typical monitoring visit.
The tools used by the monitors include regulatory and subject binders, both of which are provided by
the MCC Clinical Trials Office.  The monitors also use an existing Web-based clinical trials management
system to extract basic study information when they begin their monitoring visit.

Goal of the Project

The main objectives for the project was to:
- increase efficiency in data entry for the Clinical Trial Monitoring process,
	- make the procedure run faster and better -> web application.
-implement search function,

	- unknown number of trials being monitored,
	- thus increase efficiency,

- minimize user errors.


Thus, we, first, aimed to make this procedure run faster and better. In order to do this, the team has decided to focus on the interface design
of the data entry section of the project: a web application.




However, choosing to design the data entry section means taking into account that the data entry itself will require
an embedded interface design in order to make this most efficient for a user who plans to be making use of this program
on a normal basis.  Also, one of the main goals will be minimizing user errors like neglecting some sections.

Another focus for this project is the search function.  Due to the unknown number of trials being monitored, a well
designed search function would also increase efficiency to this project.  In addition, a way for a person monitoring
these trials to create reports easily would also prove invaluable.  Since our goal is to increase the efficiency of
this task by means of web application, we are assuming that the user login is something to be handled by the department
which will be using this application.
Team Strength and Tools

Our project's final product is to be a web application, and therefore will have some HTML inside of it.
Due to the large amount of data involved, there will also be a database involved, for which we used MySQL.
Also, since our group does not have a common language we all share knowledge in, it was decided that PHP will be used
due to its object-oriented programming capabilities, it is a comparatively easy language to learn, and it can be
interfaced with the database.  We decided against Ruby and Perl because although Perl itself is powerful, it can
also be a bit difficult to use; Ruby would work well, but since it can be extremely difficult to install into a server,
we decided that too would not be a good fit.  This worked well and we would recommend this type of a project to other groups.