OpenClinica

"Open-Clinica 4 (OC4)"

Kommentare: Data validation and data management are one of the most critical aspects of Clinical Research as they portray the end result of a study. With open-clinica,you can expect to capture a high quality dataset which has been pre-validated and monitored.

Vorteile: The software is very user friendly and yet embedded with very powerful functionalities for creating a study. It also allows the extraction of datasets in various formats in a very well organized output with some being pre-coded for ease of use.

Nachteile: Still a few limitations with customizing the user interface, but a great improvement from the previous versions.

"I used OpenClinica for ~3 years and found it a flexible and reliable system. "

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.

"Difficult to use for doctors (maybe easy for programmers)"

Kommentare: This program is a difficult program, which I tried to use for my clinical trial. Building the case report form took ages, and a lot of frustration. Furthermore, using the CRF is not intuitive at all. I am quite disappointed.

Vorteile: nothing

Nachteile: the lack of ease of use

"Good Research Study Database"

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

"I use OC 3 for over five years and found it a good electronic data capture system"

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