OpenClinica is a web-based open source software tool designed to capture clinical study data. The standard way to capture data in clinical studies is via Case Report Forms (CRF) which are specifically designed to collect study data in a structured format.
OpenClinica CRFs can be completed for all participating subjects and can be reached from various locations in the world, allowing OpenClinica to be used for multi-center studies.
The sponsor of the study is responsible for designing CRFs that accurately represent the protocol of the clinical study, as well as managing their production, monitoring data collection and auditing the content of the completed CRFs.
Since 2011 TraIT hosts and supports the OpenClinica Community Edition for use in investigator initiated studies. Currently over 220 clinical studies and almost 2000 researchers/research team members use the TraIT OpenClinica environment for data collection.
Aims of the hands-on workshop:
In the workshop you will be able to get hands-on experience with OpenClinica and complete a number of tasks yourself:
Learn about OpenClinica from end-user perspective
- complete case report forms for one clinical study
- perform QA (auditing the results from quality control measurements)
- export data from OpenClinica
Learn about possibilities to link to other applications
- Use case: link to XNAT image from a CRF
Learn about OpenClinica from data manager perspective (optional)
- Build a study in OpenClinica, using standardly available CRFs
- Create your own custom CRFs and use these in your OpenClinica study
A manual will be provided to guide participants through the different steps of the workshop. Two persons from the TraIT OpenClinica support team will be present to answer any questions.