13.2 Design Participate Forms

Once Participate has been activated (see Activate Participate), Data Managers can designate Forms within Visit-Based Events as Participate Forms. Participate Forms are not available for use in Common Events.

 

To make a Form a Participate Form:

1. In Study Designer, click the Form you want a Participant to complete.

2. Select the Participate Form checkbox.

 

Tracking Changes to Participate Settings

All manual and systematic changes to Participate Form and SDV settings related to Participate Forms appear in the Activities section of the panel on the right that can be expanded by clicking <. 

 

Participate Forms and Permission Tags

Permission Tags do not apply to Participants. If a Form is designated as a Participate Form, Participants are able to see that Form, regardless of the Permission Tag to which it is attached.

If a Participate Form has a Permission Tag attached to it, only OpenClinica user roles that have been granted access to that Permission Tag (as well as Participants) are able to access that Form.

 

For more information on Permission Tags and User Roles, see Add Tags and Define Configurable User Roles.

Using Participate Forms

Once Participate is active and Participant Forms have been published, the Participant Form is available for use. See Invite Participants and The Participant's View for more information on using Participate Forms in your Study.

Participate forms can be accessed on a Participant’s computer, tablet, or smartphone. Below are images of a form on each device:

 

 

 

Computer

iPad

iPhone

 

Participant Contact Information

Instructions for collecting and displaying Participant contact information on a form:

Reference the following instructions when inserting Participant contact information fields directly into form. This feature is intended to supplement collection of contact information through the Participant Details page. It allows this data to be captured, displayed, and updated directly on a form, including by Participants accessing the form using the Participate module. contactdata collected on a form is not stored with the rest of the form data but rather with the contact information to enforce access limits by user role.

  1. Create a text item in your form.

  2. in the bind::oc:external cell for that newly added item, select contactdata from the drop-down list.

  3. Add a column called instance::oc:contactdata. Enter one of the following values:

    • firstname - to collect first name

    • lastname - to collect last name

    • email - to collect email address

    • mobilenumber - to collect mobile phone number

    • secondaryid - to collect an alternate ID

  4. The constraint, constraint message, and constraint type (strict, see hard checks section) will automatically be set by the system to ensure data collected meets system requirements.

  5. The item must not have a value entered in the bind::oc:itemgroup column.

  6. You can define any label, hint, relevant, and required that you want for the item.

Notes: 

Only Clinical Research Coordinator, Investigator, and Participant users will be able to open a form using a contactdata item or see data from it in extracts.

It is recommended that contactdata items and other data items not be mixed on the same form due to these access limitations.

 

Mobile phone number is stored internally along with country code (for example +123 456789012345). Once a value has been collected, on either the form or from the Participant Details page, it will be displayed in that format with country code (including +1 before US phone numbers). The form will permit phone number entry in either the +, country code, space,and number format or as strictly a 10-digit number that is assumed to be for country code +1.


Approved for publication by ktamm. Signed on 2020-05-05 1:50PM

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