Transcript Presentation III

GCRC Study Database Wizard
Logan Clements
Advisor:
Dr. Paul Harris
Problem Statement and
Significance
• The General Clinical Research Center (GCRC)
facilitates patient-oriented research for many
medical disciplines. Scientific protocols are
diverse and often very different in scope and
duration. However, there always exists a need to
record and organize data from each study.
• Approximately 6 new protocols are submitted
each month.
Proposed Solution
• Create a database “Wizard” using Microsoft Access that will allow the
creation of customized database applications for different GCRC
research protocols.
• Even though there are approximately 6 new protocol submissions per
month, only 1 or 2 would be able to benefit from this type of solution
as a result of study size constraints.
• The database “Wizard” will consist of four major parts:
– Study Initiation / Setup: Provides entry of study measurements, study
visit date information (ARM, day, and description), and visit measurement
information.
– Patient Setup: Allows the entry of new patients into the database, patient
visit day information, patient demographic information, and patient
schedule generation.
– Data Entry: Provides data entry form (based on patient, study ARM and
day) and table (based on patient or measurement) modalities.
– Data Export / Reporting: Allows the export of data from the database to
other Microsoft applications and the creation of printable data reports.
Project Objectives
• Modify and correct bugs in the ‘Study Initiation / Setup’
and ‘Patient Setup’ sections of the “Wizard” created by Dr.
Harris.
• Design and create the ‘Data Entry’ and ‘Data Export /
Reporting’ sections of the program.
• Modify the database “Wizard” prototype to provide userfriendly interfaces and clear directions.
• Test prototype using real GCRC study data.
• Produce a fully functional finished product by April 2001.
Database Terms and Use
• Form: An object that supplies a record-by-record view of database
records, such that data input and editing can occur.
– Used to construct the interfaces for the four components of the database “
• Table: An object, consisting of rows and columns, that holds a
complete record of the data and can be used to input or edit data.
Three were used for creation of the “Wizard” program:
– ‘Day Description’: Contained the information corresponding to the
measurements to be performed on a certain day within the study.
– ‘Nurse Log’: Contained the actual recorded data from the study.
– ‘Demographics’: Contained the demographics information for each patient
within the study.
• Query: A way to ask a table or tables certain questions. A select query,
for example, lists the records that satisfy a certain parameter.
– Used for the manipulation of tables based on form entries and the
construction of reports.
• Report: An object that pulls together data from a table or a number of
tables and presents the information in a readable, well-designed
format.
Study Initiation / Setup
Visit Date Information
• Information Entered:
– ARM: Study cohort level.
– Day: Number of days into the
study ARM measurement will
be performed.
– Type: User-customized field to
specify the type of visit.
– Short Description
• Action:
– Modifies tables that contain
study day description
information and main nurse log
table that will contain all of the
study data.
Study Initiation / Setup
Study Measurement Information
• Information Entered:
– The measurements that will be
performed in the specific
protocol.
• Action:
– Modifies tables that contain
study day description
information and main nurse log
table that will contain all of the
study data (adds columns
corresponding to the
measurements)
Study Initiation / Setup
Visit Measurement Information
• Information Entered:
– The measurements to be taken
on a specific ARM and day.
• Action:
– Selecting the check box
corresponding to a
measurement changes the
value within the day
description table from 0 to –1
for the measurement at the
selected ARM and day.
Patient Setup
•
Add a Patient to Database
– Modifies Demographics table by
adding patient demographics
information.
•
Demographics + Schedule
Generation
– Modifies Nurse Log table by
specifying the date of Day 0 for
each study ARM.
– Queries Nurse Log to produce a
schedule report for specific patient.
•
•
•
Edit Patient Schedule
Print Patient Schedule
Scheduling Reports
– Queries Nurse Log table for patient
schedules between two dates.
Data Entry
Form by Patient, ARM and Day
• Information Entered:
– Measurements made on the
selected patient for the selected
study ARM and day.
• Action:
– Based on the ARM and day
selected, the study
measurements are determined
from the Day Description table
(search for –1)
– Data is entered into Nurse Log
table based on patient,
measurement, ARM and day.
Data Entry
Table by Patient
• Information Entered:
– Measurements made on a
specific patients for all
scheduled days.
• Action:
– Based on patient selected, all
of the records from Nurse Log
table for selected patient are
displayed.
– Data entered is copied into
Nurse Log.
Data Entry
Table by Measurement
• Information Entered:
– Data for a specific
measurement made on every
patient over entire study
length.
• Action:
– Based on the measurement
selected with the check box, a
column representing the
appropriate measurement from
table Nurse Log is added.
– Data entered in this table is
placed directly in Nurse Log.
Data Export
• Information Entered:
– Path and file name for export
to an Excel document
• Action:
– Based on selected
measurements and
information, a query is created
to retrieve the selected
information from appropriate
tables.
Work Completed
• Comments have been added to all Visual Basic code for
future reference.
• Unique identifiers have been added to all of the tables,
facilitating data entry.
• Several bugs have been corrected in the ‘Study Initiation /
Setup’ component of the “Wizard.”
• Three data entry modalities have been designed and
created.
• Data check function, which returns a report showing all
missing measurements, has been completed
• Data export modalities have been designed and created
such that study measurement and patient demographics
data can be exported.
Future Work
• Test prototype using GCRC research data and
correct any bugs within the program.
• Distribute prototype to GCRC researchers for
testing.
• Make appropriate revisions based on researcher
recommendations.