Comprehensive Data Management System for Protocol Patient and IRB Documentation Management
T.Mackevicius, E.Radeke, T.Lad
In the age of free and open source software movement, there are many opportunities to be explored in the medical field, helping organizations achieve better data quality, reporting accuracy and management efficiency without breaking the bank.
Being a small Chicago-based cancer research organization (MBCCOP) we spent over five years for the development of our custom Microsoft Access database. Now we would like to share it at no cost with other clinical research organizations, interested in simplified protocol patient management, automated form generation for NCI (National Cancer Institute) reporting and IRB (Institutional Review Board) correspondence tracking. You will find our database to be a simple solution to complete day to day management tasks of clinical research site.
Intended audience: small to medium clinical research sites and organizations, participating in NCI (NIH) sponsored clinical research trials.
PORTS (Patient Oncology Research Tracking System) was started as a pilot project to consolidate all that data scattered throughout hundreds of Excel sheets, remove data duplication and create a comprehensive research data management solution. PORTS is a relational database built on Microsoft ® Access platform.
First what PORTS is not. It is not a Clinical Trial Management System (like OpenClinica.org), nowadays clinical research bases like NSABP and ECOG have pretty good online solutions, so there is no need to reinvent that. PORTS has certain capabilities to track protocol (study) patient progress and events, but our main goal was to create small and simple to use tool to manage protocol patient enrolment information and to create various standard reports to help complete NCI report forms.
The only requirement is Microsoft Windows operating system and Microsoft Access software. No additional software, hardware or configuration is needed. Data backup may be completed by simply copying two files. Network shared folder is required if multiple users want to access/enter data at the same time.
We selected Microsoft Access, as it doesn’t require separate server installation, is portable, has good tools for data import/export, has built in tools for dynamic representation of data through graphic charts and PivotTables, has easy interface for report and data entry form creation. Also Microsoft Access platform is very well documented, empowering users to use and alter databases without extensive training.
We decided to leave our database in somewhat older MS Access 2003 version. The main reason is the ability to have optional user-level security control, because in later versions starting with MS Access 2007 this capability was removed.
- Convenient data entry forms
- Various reports (NCI progress reports, patient treatment and F/U reports for investigators, protocol screening reports, custom reports, etc. )
- Automatically generated letters / telegrams in both English and Spanish
- Dataset queries for further research analysis
- PivotTable queries for initial analysis and NCI reports
- Multi-user work environment
- User rights management
Data bases / modules
Main data base
- Clinical follow-up module
- Lost to follow-up patient tracking module
- Protocol management / screening module
- Grant administration module
- Data entry Form A - demographics, medical history, etc.
- Data entry Form B - diagnostic imaging
- Data entry Form C - treatment
- Data entry Form D - pathology
- Data entry Forms for ObGyn patient and procedure data capture
DNA sequencing / tissue bank DB
- Tissue bank management module
- DNA sequencing module
Pathology / staining DB *under development
- Radiographic imaging
- Digital documents
- Protocol follow-up flow sheets