Welcome to OpenClinica resource page
OpenClinica is (open source) software designed for data management of clinical trials. It runs via the internet, so one can conduct a trial in several sites all over the world, provided they are connected to the internet. In cases where data entry and extraction are done within one site, no internet connection is needed.
OpenClinica enables one to define a study, sites, investigators, monitors and data entry-persons. Then design electronic Case Report Forms (eCRFs) plus checks. As a last step the study designer defines the Events, or Visits, conduct a range of clinical data capture and clinical data management functions.
If double-data-entry - a data entry quality control method- is required, this can be easily incorporated. OpenClinica comes with an intuitive interface for managing Source Data Verification - Having an Investigator put an electronic signature (a 21 CFR Part 11) on the data of a Subject - is built in and can also be easily enabled on the CRFs.
CTF currently runs a number of studies using Open Source software for Electronic Data Capture (OpenClinica) and has been a major contributor to the OpenClinica global community. OpenClinica is developed by OpenClinica LLC, formerly Akaza Research LLC, and enjoys a wealth of support from a very active community with over 15,000 users. The links on the left of this page shows the studies which currently are run by CTF Data Management team using OpenClinica and can be accessed via their respective links.
Updates and other latest news on OpenClinica will be displayed here ....