Problem Statement and Significance

1. 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.

2. 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: Allows the export of data from the database to a Microsoft Excel spreadsheet.

3. Project Objectives • Modify the ‘Study Initiation / Setup’ and ‘Patient Setup’ portions of the database “Wizard” that have been created by Dr. Paul Harris such that they function properly and efficiently. • Design and create data entry modalities that provide a useful variety of ways to enter data. • Design and create the ‘Data Export’ portion of the program such that demographics and the study measurement information can be exported. • Modify the database “Wizard” prototype to provide user-friendly interfaces and clear directions. • Test prototype using real GCRC study data. • Produce a fully functional finished product by April 2001.

4. 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.

5. Study Initiation / SetupVisit 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.

6. Study Initiation / SetupStudy 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)

7. Study Initiation / SetupVisit 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.

8. 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.

9. Data EntryForm 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.

10. Data EntryTable 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.

11. Data EntryTable 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.

12. DataExportStudy Measurement Information • Information Entered: • The fields from table ‘Nurse_Log’ that are to be exported. • The path and file name of the Excel spreadsheet file to which the data is to be exported. • Action: • Based on selected measurements and information, a query is created to retrieve the selected information from appropriate tables.

13. Data ExportDemographics Information • Information Entered: • The fields from table ‘Demographics’ to be exported. • The path and file name of the Excel spreadsheet file to which the data is to be exported. • Action: • Based on selected information, a query is created to retrieve the selected information from appropriate tables.

14. Work Completed • ‘Study Initiation / Setup’ • The combo box was activated in the visit measurement portion, which allowed the selection of a particular visit. • An underscore was added in place of spaces in the names of the measurements entered in the study measurement section, which corrected difficulties encountered in the creation of data entry modalities. • The measurements added in the study measurement section were added in alphabetical order. • ‘Data Entry’ • Three data entry modalities were designed and created. • A data check function was created which searches for missing measurements within the ‘Nurse_Log’ table and generates a printable report showing the patient ID, patient name, date, and measurement information for each missing measurement. • ‘Data Export’ • Two modalities have been designed and created such that study measurement and patient demographics data can be exported.

15. Summary • Objectives Achieved • A functional prototype of the database “Wizard” has been created that allows the creation of a customized database application for storing the data collected from various GCRC protocols. • Future Direction • Within the table data entry modalities the locations which do not require the entry of data are not marked, which makes it possible for data to be entered in the wrong locations. Therefore, modifications should be made to mark these locations within the tables. • Make revisions to the interfaces based on user requests.

16. GCRC Study Database Wizard Logan Clements Advisor: Dr. Paul Harris