10.2 Configure a Study for OpenClinica Participate

When setting up an OpenClinica Study for use by study Participants, it can be helpful to keep in mind some form design considerations and best practice recommendations. Click the topics listed below for more information.

• 10.2.1 OpenClinica Participate Forms

  
  

  One of the advantages of OpenClinica Participate is that you can design your CRFs once then use them in either OpenClinica and/or Participate as needed. Any Study may comprise a combination of OpenClinica forms and Particpate forms to best fit the design and goals of your Study. Use the same CRF template and instructions for creating all of your forms, though there are minor differences in how Participate forms are displayed and function.

  In particular, the following OpenClinica features function differently in Participate forms:

  Template Worksheet	Column Title	Participate Form Functionality
  CRF	CRF Version	Does not display in Participate forms.
  Sections	Section label	Does not display in Participate forms.
  Groups	Group Repeat Max	Cannot set a maximum number of repeats for Participate forms.
  	Group Label	Does not display in Participate forms.
  	Group Display Status	Has no effect in Participate forms.
  Items	Units	Does not display in Participate forms, hence it is a good idea to write it in left item text itself (e.g Temperature (in °F)) or collect units in a separate item.
  	Right item text	Does not display in Participate forms.
  	Column Number	Has no effect in Participate forms.
  	Question number	Does not display in Participate forms.
  	Response Type	Calculations and File do not work in Participate Forms.
  	Response Layout	The layout of responses will automatically adjust on Participate forms based on the size of the data entry device being used (e.g., SmartPhone, Tablet, or Laptop).
  	Default Value	Not supported in Participate forms.
  	Data Type	Data type of REAL, PDATE, and FILE are not supported in Participate forms.
  	Validation	Not supported in Participate forms; must use Rules to perform data validation checks. Regular expressions are not supported in Participate forms.
  	Validation Error Message	Not supported in Participate forms.
  	Simple Conditional Display	Not supported in Participate forms. Item Display Status can be used, but to conditionally show or hide an Item, write a Rule using a ShowAction or HideAction as needed.

  From within OpenClinica, you can display a form as it will appear to Participants. Go to Tasks > Monitor and Manage Data > CRFs and click the View Participant Form icon :

  

  The following image shows the same form represented in OpenClinica and in Participate, and illustrates the use of show/hide functionality on the Participate form.

  

  Participant Form Customizations

  OpenClinica can customize your Participant forms to display your organization's custom logo, to include a configurable VAS scale, or to allow Participants to upload images. Please contact your OpenClinica support team for information about custom forms.

• 10.2.2 Best Practices

  
  

  Here are some recommended best practices for designing studies and forms that use OpenClinica Participate:

  • Reference the tooltips and instruction worksheet of the CRF Template as you create your forms. Best practices, tips, and usage information are provided for each attribute on the template.
  • Keep your forms at a length that is practical for a Participant to work with on a mobile device. OpenClinica does not save data locally on Participant devices, so shorter forms can help eliminate the potential for data loss.
  • If you do not want a Participant to see forms for future Events on his/her device, schedule each Event just prior to when you want the form to be completed and connect the Participant prior to when you want them to complete the form. This way, only the forms relevant to the scheduled Event are displayed. If you schedule multiple Events in advance, all forms for all those Events are available to the Participant when the Participant is connected. Scheduling one event at a time eliminates the chance that a Participant completes a form prior to the expected completion date.