Table of Contents
- Title and Copyright Information
- Preface
- 1 I'm a new user. Where do I start?
- 2 Study design prerequisites
- 3 Visits and schedules
- 4 Visit branches
- 5 Forms
- 6 Predefined rules
- 7 Code lists
-
8
Question types and
settings
- Add instructional text to a form
- Create a coding question and coding target field
- Create a date/time question
- Create a drop-down 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
- Specify details for a rollover question
- Create a text question
- Create an age question
- Configure source data verification settings
- Classify a hidden question
- Create text for a question's hint
- 9 Randomization and treatment arms
- 10 Kit types and dispensation schedules
-
11
Updates during the study conduct
period
- About Advanced Study Versioning (ASV)
-
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 forms and visit schedule during the study conduct period
-
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 validation rules can I create on questions?
- 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)
-
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?
- What types of visits can I create?
- 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?
-
Form and validation rule FAQs
- 14 Revision history