14 OC4 Participate

OC4 Participate allows study designers to design forms for data entry directly by Study Participants. These electronic Patient Reported Outcomes (ePRO) forms are fully integrated in OC4 - the forms can be designed just like all other OC4 forms, data can be entered by Participants at scheduled times, and the data is immediately available for review by site and study-level users.

  • Participate must be activated by a Data Manager before any Participate functionality is available.

  • Site users with access based on CRC or Investigator roles can add a Participant to the study and "invite" the Participant to complete the ePRO forms.

  • Participants can access Participate forms on their own devices (smart phone, tablet, laptop, or desktop computer) and submit them back to OC4.

 

With OpenClinica Participate, you have total control over when forms are available for each participant, and the data is captured in real time. In this way you can avoid participants pre-filling or back-filling forms. The underlying audit trail contains date-time stamps that prove whether a participant completed the form(s) in the time-frame required by the study protocol.

For details on how to request access to Participate, design Participate forms, invite Participants, and more, see the topics below.

 

Functional approval by Benjamin Baumann (bbaumann), Principal. Signed on 2019-01-31 10:16PM

Approved for publication by Laura Keita (lkeita), Director of Training and Compliance. Signed on 2019-02-01 9:13AM

Not valid unless obtained from the OpenClinica document management system on the day of use.