Overview of our comprehensive clinical research site data management system that is also presented as a resource at AccrualNet.
In essence PORTS is a small, portable, easy to setup and use, and at the same time free clinical trial management system (CTMS). There are other free CTMS solutions available, like VOXCE™, but they require dedicated IT team to setup and maintain the system. On the other hand, it is comparatively easy to setup and maintain PORTS. Our solution has very low learning curve as Microsoft Access is very popular platform among researchers.
We are considering a full rewrite of the application, migrating it to LibreOffice Base and Firebird SQL combo to make it truly free. This will make PORTS accessible to the worldwide organizations that cannot buy Microsoft Office Professional. It could also open the opportunity to make our solution available on other platforms, like Linux and OS X (Mac OS).
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 (SHCC MU-NCORP) we spent over five years developing 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 comprehensive Clinical Trial Management System like OpenClinica.org or data capture and management tool like REDCap (Research Electronic Data Capture). Nowadays clinical research bases like NRG and ECOG-ACRIN 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 a catalog of available protocols, patient enrollment information and to create various standard reports to help complete NCI report forms. To track protocol patient progress and events we use on-line tool WebCollab.
PORTS was also built to help manage clinics. You can use this database to schedule patient visits, track them, send reminders, record surgical treatments, lab and diagnostic imaging results, etc. PORTS also has patient list generator for treatment planning meetings and conferences.
The only requirement to run PORTS database is Microsoft Windows operating system with Microsoft Access installed. 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, the database is portable, has good tools for data import/export, has built in tools for dynamic representation of data through graphic charts and PivotTables, has an 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. Microsoft Access supports about 25 concurrent users that can simultaneously view/enter data.
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
- Protocol management / screening module
- Grant administration module
- Digital imaging submission tracking
- Lost to follow-up patient tracking module
- Clinical follow-up 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