FAQ OpenClinica

Frequently Asked Questions

 

What do I do if I need help with OpenClinica?
If you are a customer, email us at support@openclinica.com or call +1 617-621-8585. Or, use these following public support resources:

There are also a number of great formal training options. Contact us and we’ll help guide you in the right direction based on your needs.

What is Electronic Data Capture (EDC)?
Electronic data capture (EDC) refers to a category of technology that facilitates the collection data in clinical studies. Here’s a great article that explains it in detail.

What types of studies is OpenClinica used in?
OpenClinica has been in use since 2006. Since then it has been used successfully in thousands of clinical studies, including all clinical trial phases, and from very small (e.g. 20 patients) to very large (e.g. 200,000 patients) studies.

Is OpenClinica Validated?
Yes. Each release of OpenClinica is validated according to a robust Quality System to ensure the software works as designed and is compliant with applicable regulatory guidance including GCP and 21 CFR Part 11.

What is the difference between the Community and Enterprise Editions?
The OpenClinica Community is a freely available, open source distribution of the OpenClinica technology. The OpenClinica Enterprise Edition is fully supported and offers some additional capabilities.

What are my obligations if I want to use the OpenClinica Community Edition?
Your obligations are to adhere to the LGPL license that the OpenClinica Community Edition is distributed under and to abide by the terms of the trademark policy.

What is open source?
Open source is a type of software license and development model that guarantees certain freedoms. Many commonly used software programs are provided under an open source license, such as Firefox, Chrome, Android, and Linux. Many large companies like Facebook and Apple use open source software in their products people use every day. Open source has proven to produce better software—software that is often more secure, reliable, and flexible that proprietary alternatives. Read more on open source.