Create a Study

To create an Ocean study, you will need an Ocean eForm, which patients will fill out, allowing you to collect your study data.

For your study, you can either create a new study form from scratch or customize an existing form in our core library or shared library of forms.

To learn more about eForm building and editing, please refer to our Guide to Building eForms.

In the Ocean Studies view, when you are creating a New Study, you may note that only a small subset of the available forms in the Ocean library is included in the list.

These are the forms that have been cleared for use within an Ocean Study. Most eForms in the library have been marked as OK for clinical use, but not for studies.

However, you can take any eForm, including the custom ones that you have designed, and mark it for study inclusion. You can do this by updating its Data Security Mode setting.

Note: Before you mark enable a form for use within a study, please ensure that there are no copyright or usage restrictions that would prevent its use or incur a licensing fee when used for clinical research AND there are no fields in the eForm, such as a phone number, name, or other patient health identifiers (PHI), that would compromise the anonymity of the data.

To enable an eForm for use in an Ocean Study:

1. Access your form's eForm Properties.

   • Open the form in the eForm Editor.
   • Choose "Form Properties" from the Action Menu.
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2. Select a Data Security Mode.

   • Navigate to the "Form Memory & Data Storage" tab. Use the "Store form answers as" checkboxes to choose from one of the 3 following data security modes:
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   • Clinical

     Stores form answers as an encrypted note for EMR clinical storage. These forms will not include their data within an Ocean Study. Most clinical forms use this setting.

     Select the "an encrypted clinical note" checkbox.

     Anonymous Study Data

     Stores form answers only as anonymous structured data within Ocean within an Ocean Study. This will NOT generate a clinical note. For example, this is ideal for a patient satisfaction study, where the clinician should not be able to see the patient's private answers.

     Select the "anonymous Ocean Study data" checkbox.

     Hybrid

     Stores form answers as both encrypted clinical notes within the EMR, as well as anonymous structured data within an Ocean study. This is ideal for research studies that not only collect data for the study, but also generate useful clinical data for the clinician. For example, an asthma control study may provide useful information for the family physician.

     Select both the "an encrypted clinical note" and "anonymous Ocean Study data" checkboxes.

   • Note: If you choose the Clinical or Hybrid mode, please ensure the presentation of the note to the clinician meets ethics approval for the study.

3. Save the eForm.

   • Click "OK" to exit out of the "Form Properties" window. Ensure that you click the "Save Changes" at the bottom right corner to prevent your changes from being lost.
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   • Your eForm should now be visible in the list of eForms shown when creating a new study.

Understanding Ocean Study eForm Icons

Once an eForm has been configured for use in an Ocean Study, an icon appears next to the name of the eForm when browsing the eForm library.

Once you've finalized your eForm and set it up to be available for Ocean Studies, you're ready to create your study and start collecting data. You can do this by following the steps outlined below.

• Navigate to the Studies view in the Ocean Portal.
• At the bottom left-hand corner of the screen, under "Actions", click “New Study” to create a new study.
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• Name your study, add a description if you like, and search for the eForm that you want to associate with this specific study. Once you are finished, click “Create”.
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After your study has been created, you can configure the following settings to suits your needs. Be sure to save your changes once you're finished.

Study Type

There are different tiers of studies, associated different pricing and capabilities. Contact us at ocean.tips/support for more information about these options.

Pseudonymisation

Here, you have options for configuring your study participant keys.

Do not generate a participant key for this study

Prevents the generation of a study participant key for each study entry.

Align this study's participant keys with

Allows you to follow patients across multiple studies.

Capture EMR ID with submissions

allows you to identify the patients who have submitted each study entry.

Online Access

Control the option to make your study available for patients to anonymously access and complete your study eForm via a URL that can be hosted on your own organization/clinic website. More details about this can be found in "Allowing Anonymous Public Access to an Ocean Study from a Website".

Participating Sites

If you have multiple sites that will be using your eForm to contribute data to your study, you can invite them to join you study by clicking this button.

After you've set up your study, you can start distributing the form to your patients and collecting data.

• If you've selected "Online Access", once you've added the URL to your website, patients will be able to start submitting responses.
• If you haven't selected "Online Access", you can set up tablet rules to define which patients are selected to complete your study form or you can send patients your study form through Ocean Online Messages.

Once patients have started completing your study form(s), your study data can be downloaded at any time. For more information, please refer to "Viewing Data from Ocean Studies".

Now that you have learned how to create a study, also check out the Guide to Studies to learn how Ocean Studies work, how to access your study data, and how to customize your study settings.