OpenClinica

Vorteile: The study build is straightforward, validation/derivation procedures were a breeze to create, and data extractions easy to set up and quickly provide to my statistician. Mid-study updates/amendments were a simple process and the audit trail versioning was excellent and easy to track.
There is a learning curve for the novice data manager when building CRFs. But after the first few CRFs build from scratch, it became very easy. Also the training program I took was very good (1 week face-to face-class). I was comfortable building studies on my own within a couple of weeks of taking the class. The online user community was extremely helpful and a great resource.
As I was the only DM for some time, the site/user administration was easy to manage.
As I performed all end user training, most CRAs & CRCs were pleased with the system's ease of use for the end user. I built ~13 production studies and these functioned well as traditional EDC as well as in-house double DE databases. I found the query email function was a very helpful tool.
Customer support (using Enterprise Edition) was second to none. My questions were usually addressed within a few hours after submitting the ticket. Any unexpected issues were addressed and usually corrected that same day.

Nachteile: The data load process was a bit challenging. I would recommend an easier method for non-programmers to perform this task. For complex types of reports, additional tools are needed as the included extracts can be a bit cumbersome to join (depending on the report) however I was able to utilize Excel for the majority of the reporting tasks I performed.

Kommentare: Pros:
Automated audit log tracking,
structured subject matrix for visits for visualization of longitudinal follow-up,
capability to link subject co-enrolled in two different studies,
exportable datasets,
Some metadata / information about study protocol incorporated into the database for documentation (helpful for new employees in future),
Built in discrepancy tracking which can be linked to a specific variable Cons:
Rigid user roles/privileges,
Import of data into system can be challenging because of structure,
Need IT background for initial setup/installation if you are setting up on own server and not using the cloud Wishlist for future improvements:
Easier, built-in import mechanism of data into existing projects,
Make cohort groups usable within system,
Build in more scheduling features and functionality (for example, printable list of subjects expected to arrive on a particular day according to scheduled visit dates) or create reasonably priced product for this aspect which can be used as add-on,
Make user roles more flexible/al a carte,
Allow aliases for user roles as user role titles do not match structure of every organization In my experience, many are hesitant to adopt an open source product because they may have concerns about security, reliability or functionality. After using for around 3 years and for hundreds of participants, I have found this to be a very high-quality database and certainly worth considering for small academic research organizations.

Vorteile: Automated variable level audit log/change tracking

Nachteile: Difficult to import lists/data

Kommentare: OC is a great application for clinical trial research projects. It is easy to use and easy to build CRFs. The user support team is very helpful and there is a big community of people who could be helpful. The new version of the application OC4 seems to be very promising and the team has done a great job with interdicting new functionalists.

Vorteile: OC there is an excellent application for clinical trial projects. - It is easy to build a CRF, and one does not need a technical background to develop a CRF.
- It supports multi-site studies.
- It supports multi-event studies
- It supports multi CRFs per event studies
- Support multi-section (tabs) and multi group CRF
- Supports repeating events
- Support grid layout questions which is helpful (e.g. if you wont record participant's medication history)
- User-friendly interface
- compatible with Firefox, internet explore and Chrome
- Good user support
- Easy to install

Nachteile: - OC 3 interface is not responsive ( OC4 is responsive)
- No offline data entry capability
- Programmer skills are needed to implement complex validations during CRF design

Kommentare: Solid platform, great user support, query system, design is currently spreadsheet based which appeals to the minds of programmers, lots of options for data export, have used it in multi-country clinical and observational trials.

Vorteile: Great interface for sites to enter data for their subjects, repeating rows for AEs and con meds, validated system, automatic data exports, robust querying system, dynamic display of questions on one form based on answers from another form, great visual cues for data entry staff (colors, icons are meaningful), calendar control is powerful and easy to write data cleaning checks for, version control of forms, strong data integrity (can't change pre-programmed answer sets for questions without adequate control), great user support including option to contract for development at reasonable prices, built-in support for double data entry of paper forms, stable over the 7 years I've used it for clinical and observational trials, incredible user community which makes 3rd party tools available, yearly international conferences to keep users up to date, patient PRO module is very feature laden, patient PRO module creates solid link between site CRF data and patient PRO data, I have used it for 7 years and have never lost a data point.

Nachteile: Would like to have patient compensation built-in to patient PRO module, more reports needed but are coming based on user feedback.

Kommentare: Flexible, reliable and easy to use

Vorteile: I have had a great experience using OpenClinica EDC during the last 3 years with several studies (Observational studies, Registries and Clinical Trials). It´s a web based solution to build and manage multi-sites clinical studies.
It´s a powerful platform, great user support, Data Entry and DM capabilities makes everything simple.
The study build and CRF designer allows re-use across studies. Updates and amendments are a simple process. Audit trail is excellent and easy to track and data extractions are available in several formats whenever is needed for the statistician.
Data management capabilities improves data quality and productive monitoring. Most CRAs were pleased with the system.
OpenClinica offers Cloud Services. No need IT skills for installation and setup.
Super User Training is very helpful for data managers when building CRFs.
If regulatory submission is required, the Regulatory Support Package service is highly recommended.

Nachteile: Programmer skills are needed to implement complex validations during CRF design. Complex reports should be customized in Excel after data extract.