Table of Contents

• Title and Copyright Information
• Preface
  • Documentation accessibility
  • Diversity and Inclusion
  • Related resources
  • Access to Oracle Support
  • Additional copyright information
• 1 I'm a new user. Where do I start?
  • Get sign-in information
  • Get trained as you work
  • What keyboard shortcuts can I use?
• 2 Study design prerequisites
  • Open a study's design
  • Considerations when copying a study
  • Copy a study's design
• 3 Visits and schedules
  • Create a visit or event
  • Define the visit schedule
• 4 Visit branches
  • Understand how visit branches work
  • Edit or manage a visit branch
  • Add a scheduled visit to a branch
  • Create a visit branch
  • Define the visit schedule for a branch
• 5 Forms
  • Create a form with one section
  • Create a form with two sections
  • Create lab forms
    • Tag questions on date of birth, gender, and race
    • Create the lab form
    • Define the questions in a lab form
    • What should I do if my study cannot collect data on a subject's race?
  • Create a repeating form
  • About Drug Reconciliation forms
  • Create a Drug Reconciliation form
  • Preview a form
  • Add a form to a visit
  • Import a form
  • Duplicate a form
  • Leave and manage comments
  • Manage custom rules when deleting forms and questions
• 6 Question types and settings
  • Add instructional text to a form
  • Create questions for medical coding
    • Create a coding question to capture a verbatim term
    • Create the coding context items
    • Create the coding target fields
  • Create a date/time question
  • Create a drop-down question
  • Create a file upload question
  • Create a label (repeating table only)
  • Create a number question
  • Create a question group
  • Create a question with checkboxes or radio buttons
  • Create a read-only item
  • Create a rollover question
  • Create a text question
  • Create an age question
  • Configure source data verification settings for a question
  • Define data classifications for a hidden question
  • Create text for a question's hint
  • Design and configure questions for Electronic Health Record (EHR) data import
    • About mapping questions for Electronic Health Record (EHR) data import
    • Map form questions for EHR data import
      • Map a question with units inline or separately
      • Map a question group
      • Map lab form questions
    • Data dictionary question type mapping reference guide
  • Design and configure questions for safety integrations
    • About collecting safety case data when integrating with Safety
    • Design questions to be integrated to Safety
    • Design triggering questions for safety case integration with Safety
    • Design triggering questions for follow-up safety cases
    • E2B(R3) dictionary
  • Specify Randomization and Trial Supply Management (RTSM) actions that require complete answers
• 7 Predefined rules
  • Access the Rules section
  • Validation Rules
    • About validation rules
    • Available validation rules by question type
    • Define a validation rule for text questions
    • Define a validation rule for Date/Time questions
    • Define a validation rule for number questions
    • Define a validation rule for age questions
    • Define a validation rule for multi-choice questions
    • Define a validation rule for questions with radio buttons
  • Action rules
    • Set up a dynamic question in a form
      • Define a Show Question rule
    • Set up a dynamic section in a form
      • Define a Show Section rule
    • Set up a dynamic form
      • About adding dynamic forms in live studies
      • Define a Show Form rule
    • Set up a dynamic visit
      • Define a Show Visit rule
    • Set up form associations
      • Define a Link & Show Form rule
    • Set up a question to lock automatically
      • Define an Auto-lock rule
    • Define a Send Notification rule
• 8 Code lists
  • About E2B(R3) codelists
  • About Electronic Health Record (EHR) code lists
  • About managing code lists
  • Create a code list
  • Add a code list to a question
• 9 Randomization and treatment arms
  • Define a treatment arm
  • Define the randomization
  • Define the minimization
  • Add randomization to a visit
• 10 Kit types and dispensation schedules
  • Define the kits for investigational products
  • Define kits with calculated doses
  • Define the kits for devices
  • Define kits for titrations
  • Import a pooled kit type
  • Specify when subjects can titrate
  • Define the dispensation schedule
• 11 Updates during the study conduct period
  • Update forms during a live study
    • About Advanced Study Versioning (ASV)
    • About the Advanced Study Versioning (ASV) asynchronous job
    • Add or update a question in a live study version
    • Add a new form to a live study version
    • Update a form in a live study version
    • I need to correct a multiple choice question in a live form
    • What changes can I implement using Advanced Study Versioning (ASV)?
  • Update the visit schedule during a live study
    • About inserting a visit
    • Insert a visit
    • Add a dynamic visit in the schedule of a live study
    • Extend the treatment period for subjects during the study conduct period
  • Manage study versions during the study conduct period
    • Create a new Draft study version
    • Create a new Draft version of a study to update the Testing version
    • Make a study version available in Testing mode
    • Create a new Draft version of a study to update the Approved version
    • Make a study version available in Production and Training modes
    • Update the study version that is assigned to a site
    • Archive an Approved version of a study
  • Update randomization and kit types definitions during study conduct period
    • Drop a treatment arm, add cohorts, or update randomization during the study conduct period
    • Update a kit type during the study conduct period
    • Update the way that subjects titrate during the study conduct period
    • Update a randomization list that ran out of numbers during the study conduct period
    • Update a kit list that ran out of numbers during the study conduct period
• 12 Run and download a report
• 13 Frequently Asked Questions (FAQs)
  • Form and validation rule FAQs
    • Can multiple study designers edit a study at the same time?
    • Can I re-use a form's reference code?
    • What if I include a standalone coding question in a form?
    • Can I use a form in more than one visit?
    • Do I need to design the layout of a form?
    • Guidelines for subject tags and code lists in lab forms
    • How many coding questions can I include in a form?
    • How strict should my validation rules be?
    • I am using a full data collection system for my study. Which forms should I create in Oracle Clinical One Platform, and which forms should I create in my data capture system?
    • Should I add validation rules as I create a form or save them for later?
    • Understand the options for creating a coding question and coding targets
    • What answer formats can I use for questions on forms?
    • What are the maximum lengths for form fields?
    • What information should I include in the error message for a validation rule?
    • When can I mark a form item as read-only?
    • When should I tag a question as required?
    • Why do I have to define SAS properties?
    • What is the difference between a normal text result and ranges?
  • Kit and dispensation FAQs (for study designers)
    • Can I create kit type titrations for blinded studies with open-label periods?
    • Can I dispense the same kit types in more than one treatment arm?
    • Can I include Unblinded Pharmacist kits in a kit type titration?
    • If a study has multiple periods, how many kit types should I create?
    • How many treatment arms should I create when the same treatment arm is part of both blinded and open-label periods?
    • I'm not using Oracle Clinical One Platform for dispensation and supply management. Do I have to create kit types?
    • How do I define the requirements for the investigational product?
    • Can dispensation occur outside the visit window?
    • Can dispensation occur outside a randomization visit?
    • Can an open-label product be dispensed to all subjects?
    • Can I create an open-label study or an open-label period?
    • What do I need to do to use calculated doses?
    • Can more than one kit type be dispensed in a treatment arm?
    • What is my workflow if subjects need to titrate?
    • What happens when subjects aren't allowed to titrate?
    • What if subjects can titrate some kits and not titrate others?
    • Can I include multiple products in the same kit type titration?
    • Can a site user change doses after re-randomization occurs?
    • Can a site user change doses prior to randomization during the study?
    • What is my workflow for creating device kit types managed with Oracle mHealth Connector?
  • Randomization FAQs (for study designers)
    • What randomization algorithms are available?
    • What are the rules for randomization designs?
    • When I create a randomization design, what fields should I choose?
    • What is my workflow for setting up a study with multiple periods?
  • Study version and rollover study FAQs (for study designers)
    • Can I work on and test two versions of a study at the same time?
    • I need to update my Production study because of a revision or protocol amendment. What do I do?
    • Can I have multiple versions of a study in production?
    • How many different study versions can I have for a study?
    • How do I know which is the latest version of a study?
    • What is my workflow for designing a rollover study?
  • Visit FAQs
    • What order should I create visits in?
    • Can I schedule a visit backwards from another visit, such as with a Screening visit (Day -30 to -1) and a Baseline visit (Day 0)?
    • Can I specify what happens when a subject comes in outside the visit window or misses the visit window?
    • What are the requirements for a screening visit?
    • When should I mark a visit as required?
    • Do I have to schedule all visits from the same visit?
    • How is the visit schedule affected when a visit is skipped?
    • What time zone are visit windows calculated in?
• 14 Revision history