16
Mar

Q&A Session: ClinCapture Builder Virtual Update on February 19th, 2015

We hosted our latest session of the ClinCapture Virtual Update on February 19th, 2015. Tom Hickerson, Clinovo’s Senior EDC Manager showcased ClinCapture’s self-service platform and drag-and-drop tools, and the latest enhancements added to ClinCapture Build Studio.

The attendees asked a number of questions on ClinCapture’s platform, Forms Studio (CRF designer), features, plans and more. See below a list of questions and answers that were asked during this session.

  • Do you offer online trainings?

Yes. You will see a number of different training options in the “Resources” tab of ClinCapture Builder. You can take advantage of the numerous video tutorials that will guide you through ClinCapture Builder, Forms Studio and Rules Studio. You can also enroll in complimentary ClinCapture eLearning composed of self-service on-demand modules with online quizzes, for five different roles, CRC, Study Monitor, Medical Coder, Study Administrator, and Investigator. In addition, you can also contact us via ClinCapture Builder for hands-on training for you and/or your team.

  • Is there an offline version of Forms Studio available for download?

There is no offline version of Forms Studio available.

  • Is it required to build studies manually? Can we use ODM.xml to build studies or is it possible to use an existing study to create a new one?

The first study will need to be built manually but we can assist you in cloning your studies once the first one has been created.

  • It is possible to publish a full study at once, or does each CRF need to be published separately?

We recommend that you follow the work flow and publish each CRF as it is completed but you are definitely able to start by creating your study, add your CRFs and publish the study once you have all the CRFs created.

  • Is the Forms Studio divider an aesthetic option or does it have an impact on the data structure/format?

The divider is an aesthetic option that allows you to break up your forms. You also have the option to break up your forms by adding another CRF page.

The upcoming session of our one-hour ClinCapture Virtual Update will be hosted on Friday, March 26th at 10am PST. Register for this virtual update at http://www.clinovo.com/virtual-update to see the latest enhancements to EDC system, ClinCapture.

For questions, please contact Molita Sorisho at Molita.Sorisho@clinovo.com.

22
Jan

Q&A Session from ClinCapture Builder Virtual Update on January 9th, 2015

We started the New Year at Clinovo by hosting the latest session of ClinCapture Builder Virtual Update on January 9th, 2015. During the live demo, our Senior EDC Manager Tom Hickerson showcased ClinCapture’s self-service platform and its do-it-yourself edit checks and case report form (CRF) build features recently added to ClinCapture, the only free validated Electronic Data Capture (EDC) system on the market.

The demo followed by a Q&A session to guide clinical trial professionals in their clinical study build efforts. A number of questions were asked by our participants on ClinCapture’s platform, Forms Studio (CRF designer), features and more. See below for a list of questions and answerers that were asked during our ClinCapture Builder Virtual Update on January 9, 2015

  • Is there a way to control which revision of a CRF a site is able to use? Yes. When visits are created in sites, there is an option available to hide all, one or specific numbers of CRF versions from a specific site. This feature is flexible and very easy to use.
  • How can ClinCapture be used for data collection in the medical device industry? ClinCapture is flexible enough that it can collect data taken either from a patient with a medical device during a doctor’s visit, or taken from a patient entering data by themselves with our ePRO solution. Clinovo currently has several medical device companies who actively use ClinCapture.
  • When extracting CRFs from the database, does the CRF version show in the header/footer of the pdf version of the CRF? Yes, the CRF Version number or name will be shown in printouts of the Subject Case Book or other printouts of the data.
  • Can you upload CRFs in Excel, or can they only be created in the form builder? Yes, once you have deployed a study using ClinCapture Builder, you are able to upload CRFs using Excel.  Furthermore, it’s worth pointing out that all the CRFs generate from Form Studio can be downloaded to excel from the CRF page as well.
  • Can you tell me how to make a local installation of Clinovo? As you may know, ClinCapture is open-source and you are welcome to download the ClinCapture application and install it on your system.  You can find out more information here: http://www.clinovo.com/downloads.  Please note however that your installation and system features will need to be validated, an estimated 15 man-month effort, before you can use it to collect and submit data to the FDA.  If you need a validated EDC system, you have the option to use ClinCapture for free or pay a low monthly hosting fee, depending on the features you need and your study size.
  • Can trial data be exported from the system?  If so, in what format(s)? ClinCapture is based on the CDISC ODM XML format, and as such can export your trial data in either that format, or Excel, Tab-separated values, SPSS or SAS.
  • Can we have multiple versions of the same form active in the production databases which are linked to a protocol version so depending upon IRB approval of the protocol can they see different CRFs? ClinCapture does allow different form versions to be active during study collection, and you can specify which of these form versions are visible for a specific site, so you have a great deal of control as to how many or how few versions you can have in your study at any one time.
  • How are partial dates stored? Our system allows you to enter the full date or month/date or the month/year or just a year.
  • Can you only archive one study from a group of studies? No our system will allows you to have more than one study in an instance with an option to archive one or all.
  • Is there a way to demo features in Premium/Ultra plans before switching? Most definitely. Our sales team will be able to demo features that are currently in Premium and Ultra plans.
  • Will all versions of the forms be included when is a study is archived? When archiving forms at the end, you will see a download bottom in your instance with all forms archived. The forms are also sent to you via email so you will always have access to all the forms that you designed.

The upcoming session of our one-hour ClinCapture Virtual Updates will be hosted on February 19th at 10am PST. Register for this Virtual Update at http://www.clinovo.com/virtual-update to see the latest enhancements to EDC system ClinCapture.

18
Nov

Internationalization and Localization of EDC: Tips, tricks and pitfalls

 

Tom Hickerson, Senior EDC Manager at ClinovoWe recently localized ClinCapture to Russian for Synergy Research Group, latest addition to our CRO partners, and thought I would share some of our best practices. We are honored that  ClinCapture is being presented by Synergy Research Group, in Moscow during the Clinical Trials Russia Conference taking place later this week. It’s always a real treat to work with a partner in the field, especially one that is working in an international space such as Russia, Central Asia, and Eastern Europe.

Tom Hickerson, Senior EDC Manager at Clinovo

Synergy is one of several partners that we’ve worked with this fall as part of our CRO Partnership Program, which gives us the opportunity to collaborate with CROs in the US and international fields. This is an exciting opportunity, as it allows us to collaborate with an entire ecosystem of global partners, and quickly take their feedback into account while we keep improving ClinCapture.

The challenge of Internationalization and Localization (often shortened to I18N and L10N because they are eighteen and ten letters from the first to the last letter) in an application is always a daunting task, especially in a project that has over ten years’ worth of development history. It’s worth pointing out that I18N refers to creating a system that has the potential of being translated to multiple languages, while L10N refers to the process of adapting a system to a specific language, which has already been internationalized. In our case, ClinCapture has been through multiple rounds of I18N, and the last round of L10N is taking place in Russian.

I’d like to write a little bit about how far we’ve come since the first internationalization project for ClinCapture. My first take-away to our readers: When you develop a feature, you need to assess from the start if this feature will need I18N/L10N, versus a feature to be used only in English, and implement with that requirement in mind as you work with the development roadmap.

I originally helped implement the first I18N changes in 2007 to OpenClinica, by implementing changes from an outside company called BAP Health in Spain. They were one of our first outside collaborators, and the I18N drive was completely driven by them as an open-source, community effort. It opened up the ability for us to apply our solutions to a number of European and Asian organizations and agencies, and was a great step forward in making the project more popular to its growing community.

Sharing the same open source code, ClinCapture has always been available in a number of languages since that time. However, we’ve grown quite a bit in the last two years, and the code and feature set for ClinCapture is much different now. There are certain challenges that you have to keep in mind as you grow an application and develop new multi-language features. They include the following:

  • Alphabets, and their encoding. ClinCapture has always captured data in a character encoding that allows for foreign alphabets, called Unicode. (For more on the subject and how this is a complex issue, you can read the landmark article by Joel Spolsky for developers here.) Now, you may get the impression that this is not really an issue, until you start to work with text files yourself. Editing files in Notepad, for example, will create one kind of encoding for your computer, while editing files in Microsoft Word will create something entirely different.
  • Dates. In working with dates, you quickly find out that Czech dates, French dates, Russian dates can all differ on the web page, but all have to be cleanly read and saved into the database in the same way. We’ve worked with many calendar widgets in the past, but are now upgrading the ‘date picker’ for all our dates to the latest standard in our upcoming releases. You can see more about the work we’re doing with that here.
  • Making sure your code is not affected by non-English characters. ‘Code’ exists at many levels, especially when we are talking about a rich web application like ClinCapture, which has Javascript running on the browser side and Java running on the server side. It’s especially important to review the Javascript and make sure that a word in Russian won’t accidentally break code, for example, where we were only expecting words in English.
  • Making sure settings are accurately reflected in the application. Up until now, ClinCapture kept track of its user’s language settings by looking at the browser setting. Our experience has been that sometimes, different browsers interpret the default language differently. Also, the language of the operating system may affect the browser’s language setting as well. To counter this unpredictability, ClinCapture will now ask for the user to define the language specifically. You can see more about the work we’re doing with that here.

The Developer Team and Testing Team are working very hard to make sure ClinCapture is the best not only in English, but in any language. There are always a number of issues with making sure any application is fully compliant and fully internationalized. Our engagement with partners and clients like Synergy Research gives us a short, positive feedback loop within which we can quickly find and fix issues with multiple language support.

What do you think about our technical feature set and roadmap for ClinCapture in the future? You are always welcome to sign up for a community account and contribute to the discussion here at our community development site. Also, if you are an international user or CRO and would like to see ClinCapture in your local language, you can contact us about collaborating with us in our next localization efforts.

Tom Hickerson, Senior EDC Manager at Clinovo
+ 1 800 987 6007
tom.hickerson@clinovo.com

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