Welcome to CST
What is it?The Clinical Study Tracker (CST) is a simple software suite of tools which is used to track progress and completion of medical tests performed on participants during a clinical study. Front page has ‘file folder appearance’ which allows for easy, understandable data entry. Each activity (or medical test) is comprised of a sequence of activity steps (or process steps) which are assigned a date field (where the completion date of the activity step is entered). The tool suite comprises of an Administration Tool used to setup the database, and a Logging Tool for logging progress data. CST is freely available under the Apache License 2.0.
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The application was originally developed to track study members who were participating in a three year clinical study led by the Lifelong Health and Ageing Unit of the Medical Research Council UK. The original idea for the application came from Dr. Sheila Raynor, who was responsible for tracking study members through a series of cardiovascular tests which all required different amount of post processing. The software code was developed by Kevin Garwood.
Main benefits and features for end-users
Software allows for study coordinators to set up the tool at beginning
of a study based on only 3 key criteria:
- Participant identifiers
- Name of medical tests to be performed on each participant (For example: cholesterol blood test, electrocardiogram, treadmill test, etc.)
- Names of processing steps for each medical test in order to obtain final results for the study (For example a blood test: blood is drawn, taken to the lab, results received from the lab, results are placed into main study documents).
- NOTE: the application is NOT designed to hold individual medical test diagnostic results but rather to date track when the test was completed. Therefore completion rate is improved.
- Application tracks changes made to the data by identified users or participant identification number for a complete audit trail
- Progress reports can be quickly generated as graphs or tables for even meetings called at short notice
- Importing core data (participant identifiers) can be done through manual data entry or in bulk by spreadsheet by using the Administration Tool.
- Easily deployed as a standalone application or as a component of another software application
- Tool can be re-configured for another study by a non-programmer which promotes re-use of the tool
- Rapid prototyping through an in-memory demonstration feature allows the tool to be quickly re-configured for future clinical studies
- Minimal feature set allows for inexperienced computer users to run the tool in a minimum amount of training time. Good for emerging worldwide organisations
- Software assumes multiple users will be inputting data, therefore the tool tracks data entered by each identified user as an audit trail which can be printed. In addition the tool can identify error prone users which may require further training
- Designated users can be added or deleted at any time through the Administration Tool should staff change
- Designed for clinical studies with a limited budget who cannot afford bespoke or commercial software tools
- Software tool allows for junior staff to do work normally done by more experienced workers saving considerable cost
- Reduces lost or incomplete data in clinical trials because tool shows the progress of each participant individually
- In depth software design explanation for developer use
- Support data migration should projects need to expand
- Planned software exit strategy to spreadsheets should tool is no longer required
- Exporting core data (participant identifiers) can be done via the Administration Tool
- Generates clinical study forms from an XML configuration file that holds definitions of activities, activity steps, database table names and database configuration details
- Software design and open source license allows clinical studies to share main code base without requiring them to expose sensitive information about their study
- Currently in use on a major MRC UK clinical trial
The software application, its code base, and an exhaustive set of design documents are all made freely available under the Apache License 2.0. The license allows you to adapt the code without having to make your changes publically available. Furthermore, the software was designed to help you isolate the sensitive information in your study so that you can help stabilise a shared code base used by other clinical study groups.
CST was developed with a limited budget in mind. To make the most of our funding, we decided to focus on supporting a minimal feature set which did one thing well. From the onset of development, we also needed to ask:
"How do I stop using Clinical Study Tracker? What will happen at the end of the study with the information?
CST has been designed so that you can use it as long as needed, and then migrate all of your data to something else (including a simple spreadsheet if desired) when the application no longer meets your needs or the organisation grows out of it.
Who should use it?The software is well suited for clinical trial coordinators, study managers, nurses, or even junior administrative staff. It was designed so that most staff could be trained in about 30 minutes. Any project that involves multiple streams of activities, varied arrival times, and different process steps to complete is ideal for the software. Suitable for small clinical projects on low budgets who cannot afford a commercial solution, or where commercial solutions may be too complex for the user base. The software is probably ideal for university or NGO groups doing work in small-scale clinical trials.
Who should NOT use it?CST emphasises a minimal feature set so that the software can be adapted and maintained by small projects. It can be extended in various ways. But it is not intended to be a turn-key software solution which keeps track of everything in your clinical study. It was mainly designed to track the dates on which your case studies complete some step in an activity.
A Special note about the web site materialsWe have decided to put this part in glowing red. You will find dozens of sample data files and images throughout this web site which appear to describe case study members. Please note that all of the case study records in the examples we use are FAKE.
We use many of the same activities but for the release we worked with an artificial data repository. The naming of patient studies used for the examples doesn't even follow our own in-house conventions.
Special ThanksWe would like to thank MRC Technology for fostering the release of this CST as an open source application.
(c)2010 Lifelong Health and Ageing Unit of the Medical Research Council.