GCRC Study Database Wizard

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

2. 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.

3. 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.

4. 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 user-friendly interfaces and clear directions. • Test prototype using real GCRC study data. • Produce a fully functional finished product by April 2001.

5. 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.

6. 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.

7. 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)

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. DataExport • 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.

14. 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.

15. 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.