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

22 January, 2015, by ClinCaptureTeam

We started the New Year at ClinCapture by hosting the latest session of ClinCapture Builder Virtual Update on January 9^th, 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. ClinCapture currently has several medical device companies who actively use ClinCapture EDC.

• 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 ClinCapture ? As you may know, ClinCapture is open-source and you are welcome to download the ClinCapture application and install it on your system. 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 19^th at 10am PST.