Our client recognized the opportunity to gather patients’ health data in order to perform various analytics, for their health wellbeing. Gulf Coast is a prospective registry of patients admitted to hospitals and diagnosed with acute coronary syndrome. The participating countries were Bahrain, Kuwait, Oman, and United Arab Emirates.
Modules
The proposed GCR Data Management contains different modules keeping entire system organized and clean that includes online creation, modification, and deletion of CRF (Clinical Research Form), which contains informational data for every individual patient, used to perform statistical analysis.
The modules can be reviewed as per countries and hospitals wherein authorized roles or users such as Doctor or SO (Site Officer), Hospital or CSO (Chief Site Officer), Country Coordinator, and Admin, have privileges or permissions to add, edit, delete, activate, deactivate records in ascending order of levels, with SO lowest and Admin highest.
Roles & Permissions
The authorized user present at each level has certain duties to perform. As the hierarchy goes higher the responsibilities increase, adding up more privileges, not accessible by lower users. SO deals with allotted CRF, do follow-ups, and generates reports.
CSO deals with all SOs CRF, follow-ups, and reports. Country Coordinator deals with all CSOs CRF, follow-ups, and reports. Finally, Admin has complete control over the whole system including Country Coordinator, CSO, and SO.
Validation
All the data fields present in the CRF (Clinical Research Form) have different forms of validations integrated that enable users to fill in authenticated and correct information eliminating any chance of form filling errors.
- Range Validation makes mandatory for users to fill information that lies within the validated range. Information filled outside the range not accepted.
- Required Validation enables users not to keep the data field empty. They have to fill in the information that is must.
- Dependency Validation lets users fill specific information in a data field that is dependent on the answer of any previous data field. If the earlier data field has a certain answer then the latter data field should have a specific answer only.
- Numeric Validation enables users to fill in numbers only. No other characters including alphabets are accepted.
- Date Validation lets users to fill in a date that lies in the given calendar range. Any date outside the practical range not accepted
Alerts & Notifications
Users notified with alerts incorporated with every module. They are notified while filling up the CRF in the form of validation checks, during the follow-ups when they are due, when trying to access higher-level permissions, incomplete forms in the enroll phase, and more.
- Are you sure? alert for user confirmation to proceed further.
- Alert with data inputs to verify that the information entered is invalid.
- Account creation / Change password notification when new account created or password changed.
- Follow-up / Overdue notification when it is time for users to take patients follow-up or in case there is an overdue of time.
User-Friendly Features
GCR is a highly intuitive and interactive system with a clean user interface (UI) wherein the data fields are extremely legible to read and systematically positioned for smooth viewing.
Users can directly move on to the next field, once validated, without using the mouse, typing details with keyboard. The autofocus feature lets users pause their work and resume after a while because the field where the user is currently on remains highlighted.
Tooltips are provided with each single data field to provide information on what to enter in the respective field. Information present in different data fields is differentiated with the help of varied colors. Dashboard graphs are available to all users irrespective of permission levels.
AutoSaving Option
Users when enter details for one module and move on to the next module, the data of previous module is auto saved.
Therefore, in case of system breakdown, or power failure, the data entered remains stored saving on the unnecessary time spent on filling up the details again.
Reports
Reports available for download in a graphical format and excel format. Users can generate either weekly reports or cumulative depending on the hierarchical position.
Users can even access complete data reports, log reports, and historical reports. SOs can generate reports limited to specific patients.
CSOs can generate reports of SOs limited to a hospital. Country Coordinator can generate reports of CSOs limited to a country. Admin can generate, modify, and delete any report present within the system.
CRF Functionalities
With 1 month, 6 months, 12 months follow-up phases, users kept informed regarding the CRF status – enrolled or submitted. Easy transfer of records takes place between SOs, CSOs, Country Coordinators, and Admins.
Status management of CRF is simple, once the CRF contains completed and validated details. Advanced search facility available to add, edit, view, or delete any new information no present in current CRF.
Benefits
Web based data collaboration and integration across 4 countries, 38 hospitals, and 200 doctors.
- Smart follow-up system examining monthly, half-yearly, and yearly outcomes.
- Transferring patients among centers for secure and collaborative care.
- Monitoring of health progress and data quality for individual patient.
- Continuous data cleaning from the start with data queries immediately displayed for missing fields, out of range values, and contradictory entries.
- Microsoft Excel based reports, generated anytime with just a click.
Challenge & Solution
Accumulating patient’s data from 200 doctors across 38 hospitals in four Middle East countries, and integrating them together for constant data monitoring and analytics.
Handling of a vast range of records, and health improvement became possible with the help of easily accessible health status reports.
