6 Question types and settings
You can create a multitude of question types in your forms, specify settings according to the question type, and classify hidden questions in a form.
- E2B(R3) dictionary
Mapping your questions to the E2B(R3) format is essential to the transmission of adverse event data to Safety. This ensures that the data integrates to the appropriate field in Safety. - Add instructional text to a form
When creating a new form, you can add read-only text to the form to provide users with additional information or instructions on how to complete it. - Create questions for medical coding
Create a question to capture a verbatim term, the Route of Administration, and Indication (the context items) and the coding target fields. - Create a date/time question
Create a date/time question when a subject's answer to a question includes times or date values, or both. - Create a drop-down question
Create a drop-down question when site users must select an answer from a drop-down. - Create a file upload question
Create a file upload question to let site staff or other study team members upload relevant documents in forms. - Create a label (repeating table only)
Label items allow you to add predefined read-only values to a repeating form and better control the data that is collected. Label items are read-only and can't be edited by the site user. - Create a number question
Create a number question when a subject's answer to a question includes numbers only. - Create a question group
Create a question group when you need to collect data that is related and you want to display it on the same line. - Create a question with checkboxes or radio buttons
Create a question with checkboxes, if you want site users to select multiple options for an answer. Or create a question with radio buttons, if you want site users to choose one single option as an answer out of other options. - Create a read-only item
Create a read-only item for values that site users can see but not edit. - Create a rollover question
Create a rollover question when site users must select an answer from a drop-down and enroll subjects in a rollover study. A rollover type of question is typically included in a study completion form in the original study. - Create a text question
Create a text question when a subject's answer to a question includes letters only or letters and numbers. - Create an age question
Create an age question to insert a Date of Birth question and a read-only calculated age field. - Configure source data verification settings for a question
If your study requires a targeted Source Data Verification (SDV) strategy, you must work with your study manager to configure these two settings for certain or all questions in the study. - Define data classifications for a hidden question
You define data classifications for a question when you want to create exceptions on hidden questions based on the study roles assigned by a user administrator. - Create text for a question's hint
You can create question hint text to provide site users with guidelines for data entry. Question Hint text is displayed for site users on the right sidebar when entering data in a form. - About mapping questions for Electronic Health Record (EHR) data import
If your study is enabled for EHR data import, you can map form questions to EHR elements in an Oracle-managed data dictionary and use pre-seeded EHR code lists to ensure successful data import and minimize data cleaning. - About collecting safety case data when integrating with Safety
Learn about configuring a study to automatically integrate safety case data with Safety. This includes configuring the forms you want to include in the transfer to Safety, which includes mapping each question to an E2B(R3) compliant format. - Design questions to be integrated to Safety
Configure your questions so that adverse event data is included in a safety case. You can mark some questions as mandatory, meaning that Safety does not receive the safety case event until a site user answers all required questions. - Design triggering questions for safety case integration with Safety
Configure a question to trigger the integration of subject case data with Safety. - Design triggering questions for follow-up safety cases
Configure one or several of the questions in your forms to trigger the creation of follow-up safety cases. - Specify Randomization and Trial Supply Management (RTSM) actions that require complete answers
Specify which questions are required to be completed for screening, randomization, and dispensation visits.