Welcome! Here you’ll find some helpful information to get your Study Subjects really participating in your Study by allowing them to use their own internet-connected devices to provide data directly into OpenClinica Forms. This allows for more accurate and timely responses promoting a higher level of Subject compliance. It also means that clinic staff can spend more quality time with Study Participants, and less time on administration.
Starting with OpenClinica 3.7, you also have the option of setting up a Study that allows anonymous submission of Participant Forms. This allows for broad-reaching, survey-based data collection.
Here’s a video that provides a very high-level, conceptual overview of OpenClinica Participate being used in a consent-based clinical trial:
With OpenClinica Participate, you have total control over when forms are available for each subject, and the data is captured in real time. This means there is no option for subjects to pre-fill or back-fill forms. The underlying audit trail offers objective evidence that the subjects completed the forms in the timeframe dictated by the protocol.
OpenClinica Participate (OCP) works with electronic case report forms (eCRFs) designed in OpenClinica. You can design the form once and use it in OpenClinica and/or Participate as needed. To accommodate OCP functionality, the following updates have been made to the OpenClinica Study Build process:
- The OpenClinica CRF Template has been updated with additional help text and more guided instructions.
- There is an additional option to identify Participant Forms when creating Study Event Definitions.
- There is an additional option for Participant Forms to allow for anonymous submission.
- There is an option on the Build Study page that allows you to request activating Participate for your Study.
For Studies collecting data for a clinical trial, Participants must be enrolled in OpenClinica with at least one Event scheduled that contains at least one Participate form. For Studies collecting general survey information, OpenClinica generates a unique identifier and populates an Event automatically when a Form is submitted.
To activate your Study for use with OCP or to find out more about Study build considerations, see the topics below.
As always, we appreciate your feedback and contributions.
cleaner data capture so study coordinators can spend more time with their study participants and potentially enjoy higher patient compliance. - See more at: http://social.eyeforpharma.com/digital/using-electronic-patient-reported-outcomes-epro-first-time-lessons-learned#sthash.rjjxm9qX.dpuf