Create and Edit Study

To create a study:

  1. Go to Studies from the navigation menu on the left and click on "+ New Study".
  2. A study builder window will appear
  3. Select the product of interest for your study
    buildproducts

  4. SMART-TRIAL offers a range of add-ons to your study, enable the add-ons relevant to your study and click "Next"
    buildaddons

  5. Enter the name of your study and a brief description if desired. 
    buildname


  6. Select mandatory and optional subject attributes used for the identification of subjects
    buildattr


  7. Enter the primary and secondary languages for the study and select study country. Add an ethical committee number if applicable.
    buildgeo


  8. Specify verification labels if wanted and select the date and time format for the study
    buildver

  9. If White Labeling add-on is enabled, provide a link to your logo, enter the e-mail and SMS sender. 
    buildwhite

     

  10. If Adverse Event add-on is enabled, select the template of choice  

    buildae

SMART-TRIAL products:

You can select one of the following four types of products:

  1. eCRF for pre or post-market clinical investigation

  2. ePRO to collect data directly from the subjects (patients, physicians ect.) over a longer period

  3. Survey for collecting one time data from subjects 

  4. Suite for including both eCRF and ePRO to collect data from healthcare professionals and subjects (patients, physicians ect.)  

Add-ons:

You are provided with a number of possible add-ons depending on the selected type of product. By enabling these, additional modules and functionalities will be available for your study. Having them disabled will hide any trace of the modules/functions in the system. The following add-ons are available for the specific products, you can click on the individual add-ons to read more about them:

Subject attributes

You can select from a range of subject profile attributes to identify subjects in your study. Subject profile attributes marked as mandatory are required to be filled in before the subject can be submitted/enrolled to a site. You can choose optional attributes if wanted.  

Tip: Send questionnaires to your subjects via email or SMS, by selecting either:

  • Email as a mandatory subject attribute for sending questionnaires via email only.
  • Email and Phone Number as mandatory subject attributes for sending questionnaires via both email and SMS.

Subject ID

There are four variants of subject ID available in SMART-TRIAL. Three automatic IDs, where the system will assign IDs upon enrolment or manual subject ID, where the user enrolling the subject will give them a subject ID.

The three automatic types of IDs are:

  • Study incremented ID
    A study-wide counter that starts at 001, and counts up with every new subject enrolled in the study, regardless of the site they are enrolled to.
  • Site ID & study incremented ID
    The id is a combination of the site ID and a study-wide incrementing number, starting at 001.
    Assume there are two sites in the study: London with the site ID LON and Copenhagen with the site ID CPH.
    The first subject is enrolled to London, so they get the ID: LON-001
    The second subject is enrolled to Copenhagen, so they get the ID CPH-002

  •  Site ID & site incremented ID
    Using this automation, each site has its own incrementing number along with a site ID.
    Assume there are two sites in the study: London with the site ID LON and Copenhagen with the site ID CPH.
    The first subject in the study is enrolled to London, so they get the ID: LON-001
    The second subject in the study is enrolled to London, so they get the ID LON-002
    The third subject in the study is enrolled to Copenhagen, so they get the ID CPH-001

The manual type of ID

  • Manually entered subject ID
    This type of ID can be applied if a study wants to customise the subject-ID. It will, however, require that the study personnel type in the subject ID of interest each time a new subject is enrolled to a site.

You cannot change between automatic subject ID's once the study has been started and a subject enrolled, nor can you remove subject ID as an attribute.

Languages

SMART-TRIAL currently supports 30 written languages. Choose a primary language of the study in which you will define all your forms and processes, and use our translations module to translate the content to other languages.

The supported languages are:

  • Chinese (Simplified)

  • Chinese (Traditional)

  • Czech

  • Danish

  • Dutch

  • English

  • Estonian

  • Finnish

  • French

  • French-Canadian

  • German

  • Greek

  • Hebrew-Israel

  • Hungarian

  • Icelandic

  • Indonesian

  • Italian

  • Japanese

  • Latvian

  • Lithuanian

  • Norwegian

  • Polish

  • Portuguese

  • Romanian

  • Russian

  • Slovak

  • Slovenian

  • Spanish

  • Swedish

  • Turkish

Verification

Verification is a tool that allows monitors, sponsors, or data managers to mark data as verified. The verification tool can be given any meaning desired by the study, as it can be named when setting up the study. Examples could be: Monitored, Source Data Verification (SDV), or reviewed. Depending on what is needed in the study. For more details, please go to our Verification article.

When creating a study or editing an already existing study, you can add up to two verification types. These work exactly the same way, but make it possible to differentiate between the two verification groups, due to the two colors. This can be useful when study personnel with different roles in the study has to verify the data independent of each other. Each verification type has their own permission. To manage the permission(s) go to add collaborators, under site permissions the two verification types will be visible.

Time and date format

You can specify the date format on a study level, which will determine how dates are displayed in the study. There is a list to choose from: EU, ISO, and US formats with different lengths, and different delimiters.

Extended Validation

If enabled, password verification will be required when an action is performed in the study.

The following actions will require a password to be input:

  • Create new adverse event
  • Sign an adverse event as classified (enforced)
  • Sign an adverse event as followed up (enforced)
  • Sign an adverse event as sponsor initial evaluation (enforced)
  • Sign an adverse event as sponsor final evaluation (enforced)
  • Amend an adverse event (enforced)
  • Update a specific adverse event
  • Discontinue an enrollment
  • Sign off an enrollment (enforced)
  • Register a medication entry
  • Update a medication entry
  • Respond to a query
  • Update questionnaire answers
  • Update study
  • Start study amendment
  • Discard study amendment
  • Finish study amendment
  • Renew API key
  • Randomize enrollment
  • 'Fill out as subject' for data event
  • Lock data event (enforced)
  • Unlock data event (enforced)

Please note that (enforced) means the actions require a password to be input regardless of Extended Validation

To edit a study:

  1. Go to [Study Name] > Study Info.
  2. Click Edit Study button.
  3. Make changes to the study information and click Save.