10 Share and Edit Study Settings

Once a study has been created, Data Managers can design the study, share that study with sites and users, edit the study settings, define and edit Participant ID settings, and publish the study to either the Test or Production environment.

Designing a study is addressed in the link above. The remaining topics are addressed below.

Access the Share Page

The Share features allow you to add Sites and invite users to access your study. In the Share interface, you can also access Study and Participant ID settings and User Roles.

To access the Study or Participant ID settings, access the Share page as follows:

  • From the Design or My Studies page, click Share and select either Test or Production:

Design:

  My Studies:

           

The Share page for the selected environment displays.

Add Sites

If you are going to invite site users to access your study, then you should first add the site. To add a site, in the Sites section of the Share page, click Add:

Start to type the Site name, then select the Site from the list or select the option to Add a new site.

If the Site had already been added to your other environment (Test or Production) for this Study, then the fields will be prefilled with the site information. Otherwise, complete the Site form and click Save:

Note: Fields marked with an asterisk (*) are required; all other fields are optional.

Invite Users

If you are going to invite site users to your study, add the site(s) first (see above), then invite users.

To invite a user to a study

  1. On the Share page, select the appropriate tab for the environment where the user will work. Then click Invite.

  2. Start typing the user's email address or username. If the user already exists in the Test or Production environment for this study, you can select the user from the list that displays. Otherwise, click Invite new user.

    The Add User page displays:
                                              

  3. Enter values for each of the fields. For User Type, most users should have a type of User.

    Users with a User Type of Admin have access to all studies across all environments within your organization. This level of access should be restricted to as few users as possible (one or two users is the norm).

    When all fields are completed, click Create User.

  4. When prompted, select a role for the user from the list of available roles:


    For more information on roles, see User Access.

  5. If you selected a site-level role, select a site from the list that is available. To provide access to another site, for example a monitor who is responsible for montoring two sites, click in the Site box again and select additional site(s) as needed.

    When finished granting the appropriate access, click Invite.

    The user is created and is listed in the People table on the Share screen.

Edit Settings

Though the Administrator is the only user role with access to create a study and define the initial study settings, the Data Manager can edit those settings at any time. In addition, Data Managers can set Participant ID settings to be generated automatically by the system based on a specific Participant ID format.

All Study and Participant ID settings apply to both the Test and Production environments, and are effective immediately upon saving the settings.

To access the Study or Participant ID settings, access the Share page as follows:

  1. From the Design or My Studies page, click Share and select either Test or Production:
    Design:

      My Studies:

               

    The Share page for the selected environment displays.

Edit Study Settings

  1. On the Share page, go to the Settings tab and to the right of Study Settings, clickEdit.

    The Study Properties page displays:

  2. Edit the study settings as needed and click Save.

    The changes take effect immediately in both the Test and Production environments for that study.

Edit Participant ID Settings

Participant ID can be set for:

  • Manual Entry: The user must enter the ID for each Participant
  • System-generated: The system will auto-generate the ID based on an ID Template that you specify

These settings come into effect when a user adds a participant to a study.

If you choose System-generated, you must specify the template for the system-generated ID. The standard template that is provided breaks down as follows:

Assuming there is a study with three sites: AAA, BBB, and CCC, using the above template the Participant IDs would be assigned as follows:

  • When Site AAA adds Participants, the Participant IDs will be: AAA-001, AAA-002, AAA-003, etc.
  • When Site BBB adds Participants, the Participant IDs will be: BBB-001, BBB-002, BBB-003, etc.
  • When Site CCC adds Participants, the Participant IDs will be: CCC-001, CCC-002, CCC-003, etc.

Things to note about the template:

  • The template cannot exceed 255 characters, and the resulting Participant ID cannot exceed 30 characters.
  • ${siteId} and ${siteParticipantCount} are both required but can be in any order.
  • Static text can be added to any portion of the template, but cannot include slash (/) or backslash (\).
    For example:
    StudyXYZ:${siteID}-${siteParticipantCount+1}?string[“000”]}
    would generate the following Participant ID for site AAA: StudyXYZ:AAA-001
  • The increment number can be changed as needed to force a different starting number.
    For example:
    ${siteID}-${siteParticipantCount+100}?string[“000”]} would generate the following Participant IDs for site AAA:
                           AAA-101
                           AAA-102
                           AAA-103
                           etc.
  • The minimum length can be modified as needed.
    For example:
    ${siteID}-${siteParticipantCount+1}?string[“0000”]}would generate the following Participant IDs for site AAA:
                           AAA-0001
                           AAA-0002
                           …
                           AAA-1000
                           …
                           AAA-9999
                           AAA-10000

There is no restriction for going beyond the minimum, but it is best practice to set up the minimum length to match the length of the maximum number of expected Participants.

  • If the template is invalid for any reason (e.g., length>255 characters or invalid characters (slash or backslash) were used), the system uses a default template of ${siteOID} followed by a dash and a six-digit random number.

Publish a Study

To publish a study, from the Study Designer, Study Manager, or Share page, click Publish and then select the environment to which you want to publish (either Test or Production).

Review the Publish Study information.

  • To cancel publishing, click Cancel.
  • To publish the study to the selected environment, click Publish and then close the confirmation window.

Once a study is published to an environment, you can Go to that environment. Only the published environment(s) are available for selection from the Go button.

If you publish your study to the Test environment, you can still change the design of your study as needed without having to change form version information. In other words, you can overwrite forms as needed. The only features that cannot be overwritten are as follows:

  • You cannot change the data type of an item.
  • You cannot move an item from a repeating group to a non-repeating group or vice-versa.
  • You cannot change the bind::oc:itemgroup value for an item.

All three of these settings affect the underlying database and would have an effect on the integrity of the data. If you need to change any of these features within a form, you can remove the original item and create a new item on the form.

Once you publish a study to Production, ANY change to a form requires you to change the form version.

 


Approved for publication by Laura Keita (lkeita), Director of Training and Compliance. Signed on 2018-09-26 12:14PM

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