clinical trials specs

Clinical Trials Management System Detailed Design Specifications

Screen Design

1. Welcome Screen

This is the initial screen displayed when the system is launched.

Clinical Trials Management System

Processing a) When clicked on the hyperlink, launch the corresponding screen.

Create and Maintain a Portfolio

Patient Visit Record

Enrol Patients

Maintain Drug

Maintain Doctor / Research Associate

Drug Administration – Exception Report


2. Create and Maintain a Portfolio

This function maintains the intended purpose, target clientele, health parameter limits of a Drug that is considered for Clinical trials.

Create / Maintain Portfolio

Portfolio Details

Trials From Date: To Date: Target Age From : To Blood Pressure - Max Min Sugar Level – Max Min Doctor (Drop Down) Research Associate (Drop Down) Intended Purpose:

Select Portfolio

Create Back Update

* Select Drug

Save Refresh Cancel

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Validations

a) For Update portofolio, a portfolio number must be selected.

b) Trials from date should be less than to date

c) Target age (to) should not be less than taget age (from)

d) Blood pressure (Min) should be less than Blood Pressure (Max)

e) Sugar level (Min) should be less than Sugar level (Max)

f) Doctor and RA should be existing in Doctor/RA table

Processing

a. When Save is clicked, either Add or Update the portfolio table (based on the

action)

b. Portoflio number is a system generated sequence number

c. When Refresh is clicked, restore the values to original values (ie. Values

displayed when screen was loaded)

d. Back should take the user back to main menu

e. Cancel should take the user back to “Create / Maintain Portfolio” screen


3. Patient Visit Record

This Function allows a doctor / research associate to document the patient health readings and observations for patients who are selected for Trials.

Patient Visit - Select Patient

Patient Visit Record

Patient: ________________________

Date of Visit:

Blood Pressure Reading:

Sugar Level Reading:

Drugs Administered: (1)

(2)

(3)

Administered By: (drop down)

Observations:

* Select Patient

Record Visit Back

Save Cancel Clear

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Validation

a) Date of visit must be equal to less than today’s date b) There should not be a record already existing in the system for the given patient

id and visit date c) Drug 2 can be entered only when Drug 1 is entered d) Drug 3 can be entered only when Drug 1 and 2 are entered

Processing

a) When Save is clicked, store the visit details in patient_visit table. Store details of the drugs administered in the Drugs_given table.

b) When Clear is clicked, clear all the data entry fields on the screen c) When Cancel is clicked, switch to the main menu


4. Patient Enrolment

This screen allows enrolment and de-enrolment of patients for a clinical trial. Patients

identified for trials should be created in this module, before drug administration.

Portfolio Patient Patient Name:

Patient Date of Birth: Gender: () Male () Female Initial Observations:

Enrol Patient

Patient Enrolment

Back Enrol Patient Cancel Enrolment

Enrol Refresh Cancel

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Patient Name: __________________

Patient Date of Birth: _____________ Gender: _________ Initial Observations: __________________________________________ Validations a) For enrolling a new patient, Portoflio number must be selected. Patient field should

be blank b) For canceling enrolment of a patient, both portfolio number and patient must be

selected. Patient must have been enrolled in the selected portfolio and in a “Enrolled” status.

c) Patient date of birth must not be later than today’s date Processing

d) When Enrol is clicked, generate a patient number (next in sequence) and add the patient details to the patient details table with a status of “Enrolled”.

e) When Cancel enrolment is clicked, update the status of patient to “Cancelled”.

Cancel Enrolment

Cancel Enrolment Cancel


5. Maintain Drug Details

Choose Drug: Drug Name: _________________________ Description: Manufacturer: Validations

a) a) A drug can not be deleted if it is associated with any portfolio or a patient Processing

b) When Save is clicked, Add / Update the drug details in the Drug master.

c) When Clear is clicked, Clear the values on the screen

Add / Modify Drug Details

Select Drug

Back Add New Drug Modify Drug Delete Drug

Save Clear Cancel

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d) When Cancel is clicked, Return to the menu screen


6. Maintain Doctor / Research Associate

Choose Doctor / RA:

Doctor or Research Associate: () Doctor () Research Associate Doctor / RA Name:

Validations

a) A Doctor or RA can not be deleted if he / she is associated with any portfolio or a patient

Processing

b) When Save is clicked, o Add / Update / Delete the Doctor / RA details in the

Doctor_RA_details master.

c) When Clear is clicked,

Add / Modify Doctor / RA Details

Select Doctor / Research Associate

Back Add New Doc / RA Modify Doc / RA Delete Doc / RA

Save Clear Cancel

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o Clear the values on the screen

d) When Cancel is clicked, o Return to the menu screen


7. Drug Administration – Exception Report

This report lists the exceptions to acceptable blood pressure and sugar levels among

patients who are participating in the clinical trials. Patient visit records, where BP

and Blood sugar details are not available, should be excluded from reporting.

Choose Portfolio Report from Date: Report To Date: Exceptions from: () Blood Pressure () Sugar Level () Both Portfolio : _____________________________________________________

Validation

Sl No

Patient Name Date Max BP

Min BP BP Reading

Max Sugar

Min Sugar

Sugar Reading

Exception Report

Exception Report – Parameters screen

Back Generate Report

Ok Cancel

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Clear


a) Report from Date must not be greater than Report to date

Processing

f) When Generate Report is clicked o Access the patient_visit table and retrieve records matching the given

selection criteria o Get Portfolio short description from Portfolio table

g) When Clear is clicked, clear all the data entry fields on the screen h) When back or Cancel is clicked, switch to the main menu i) When OK is clicked, go to “Exception Report – Specify parameters” screen


Database Design

Table Name Portfolio

Field Name Field Type

Portfolio Number Integer (auto increment) Primary Key

Drug Number Integer Foreign key referring to Drug table

Trial from date Date

Trial to date Date

Target age from Integer

Target age to Integer

Blood Pressure Max Integer

Blood Pressure Min Integer

Sugar Level Max Integer

Sugar Level Min Integer

Doctor Integer Foreign Key referring to Doctor_RA table

Research Associate Integer Foreign Key referring to Doctor_RA table

Intended Purpose Varchar(200)

Table Name Doctor_RA


Doctor_RA Number Integer PK

Doctor_RA Name Char(30)

Doctor_RA Type Integer 1 – Doctor 2 – Research Associate

Table Name Patient


Patient Number Integer Primary Key

Portfolio Number Integer Foreign Key referred by Portfolio table

Patient Name Char(30)

Patient date of Birth Date

Gender Char(1)

Initial Observations Varchar(300)


Status Char(10) Valid values are – Cancelled Enrolled

Table Name Patient_Visit


Patient Number Integer Primary Key Foreign Key referencing Patient table

Date of Visit Date PK

Blood Pressure Reading Integer

Sugar Level Reading Integer

Drugs Administered by Integer Foreign Key referencing Doctor_RA table

Observations Varchar(200)

Table Name Drugs_given


Patient Number Integer PK Foreign Key referring Patient table

Visit Date Date PK

Drug Code Integer PK Foreign Key referring Drug table

Table Name Drugs_Master


Drug Code Integer PK

Drug Description Char(30)

Manufacturer Char(30)

clinical trials specs

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