Overview: Anti-depressant B Trial Project
Our Hospital is conducting a double blind test of a new anti-depressant drug. There are 10 doctors and 1000 patients involved. The patients are given one either a generic form of Prozac or the new experimental drug. The patients are divided into group 1 and group 2. Neither doctors nor patients nor researchers know which group is recieveing which drug. Additionally no one, not even the researchers should be aware even of which group an individual patient is associated with.
The project is to create a database to track the study. In addition, given the abilities of SQL Server, we intend to develop much of the business logic for the test in the server itself, which will ultimately interface with a web site for doctor and patient use.
It is important to test the application thoroughly both for performance and conformance to the business rules listed below
The security structure of the database is essential to the success of the study. It is important that no-one including the researchers can identify which patient is using which drug
Business Rules
What follows is a preliminary list of business rules for the database and application. These rules were generated in a two day retreat which included the researchers, the doctors and 5 volunteer patients.It is not a definitive list and will be expanded as issues arise that must be resolved. The list is also not ordered by priority
- The study is for three years
- Patients are volunteers, but every effort is made to get a diverse population in terms of age, gender, and race. To track this each patient must provide demographic information
- Additionally each patient should provide previous medical history and history of their depression
- Patients must be interviewed and give a physical at least once a month.
- The physical involves a blood test that checks their kidney, liver function , their blood sugar levels,their heart rate, blood pressure, temperature, and weight
- Each patient will also do a questionnaire about their depression including information on sleeping, eating and general mood, thoughts of suicide
- The doctors notes are stored in the database and must conform to an xml schema
- Patients may drop from the program or be dropped if the doctor determines there is sufficient risk that requires the patient receive more direct treatment.
- Doctors can suggest that a patient be dropped from the program, but they cannot actually drop them. Only a researcher can do that. A patient that is dropped is flagged as dropped in the database, but not deleted from the tables
- New patients can be added but no later that 1 year into the study—start dates should be recorded.
- If the total number of patients falls below 300 the study is invalidated and must start over
- Doctors can drop out of the program, new doctors can be added (Again doctors that drop out of the study are flagged but not removed from the database
- Patients are assigned to a doctor, but can be seen by any of the doctors in the study
- Patient appointments should be tracked and scheduled. Ideally patients should be able to make an appointment and check their appointments on-line
- A doctor should have access to the notes of any patient whom he or she is scheduled to see
- A patient should be able to see a subset of the doctor’s notes (this needs to be defined) about them (but not see any other patient’s notes)
Other Notes: There is pre-existing data that must be incorporated into the database
Other Materials
xml and xml schema for doctors notes
Preliminary database structure
Other materials