Table of Contents
- Title and Copyright Information
- Preface
- 1 Customize the workspace
-
2
Create and configure a
study
- Set up study parameters
- Set up study teams
- Configure study administration data
-
(Optional) Create predefined sets
of drop-down list options, radio buttons, or checkboxes (codelist subsets) in a
study
- Step 1: Create a drop-down list or set of radio buttons or checkboxes (a codelist with codelist items)
- Step 2: Define sets of drop-down list options, radio buttons, or checkboxes (codelist subsets)
- Step 3: Require study designers to select subsets when they are defined for a codelist (Optional)
- Delete a codelist subset
- (Optional) Create review states and stages for use in the InForm Data Viewer
- (Optional) Restrict study design activities
- (Optional) Attach a reference to a study
- Lock the study administration data settings
- (Optional) Remove a reference from a study
- (Optional) Set up your study for coding
-
3
Create and configure a
library
- Create a library
- Set the primary layout for a library
- Select the supported locales for a library
- Choose the default locale for a library
- Set up library teams
- Add a study object or library object to a library
- Categorize a study object
- Create predefined sets of drop-down list options, radio buttons, or checkboxes (codelist subsets) in a library
- Create a study object template
- Create an item type
- Mark an item as mandatory
- Protect a library and all its objects
- Unprotect a library
- Publish an object to make it available to copy into a study
- Publish, republish, or unpublish a library to make its objects available to copy into a study
- Disable a library
- 4 Import and export study objects
- 5 Use tasks and notes to create collaboration
-
6
Design custom events
- Step 1: Create a custom event
- Step 2: Add a trigger for a custom event
- Step 3: Add a result for a custom event (the data to export when a custom event is triggered)
-
Step 4: Specify run
options
- Set the priority for your custom events
- Configure a custom event to run retroactively on existing data
- Make a custom event dependent on another custom event
- Change the endpoint name of more than one custom event
- Mark a custom event change as an in-place revision
- View the differences between two versions of a custom event
- Import custom events
- Deactivate a custom event
-
Example of Oracle InForm to Siebel CTMS integration
- Create a subject with a status of Enrolled
- Initiate an early withdrawal
- Mark a visit as complete and specify the date of visit as the completion date
- Mark the cycle 1 visit as complete and specify the date of visit as the completion date
- Update the date of visit item on the subject completion visit whenever it is changed
- 7 Create and test rules
- 8 Data mappings
-
9
Validate and deploy a study
- Before you begin: Make sure the workflow is valid
- Follow this four-step process
-
10
Perform post-design
activities
- Lock and protect studies and libraries
- Archive and decommission a study
-
Generate reports
- Generate, save, and print a report
- Data Entry Rule Actions report
- InForm RefName report
- Library Objects Modified in the Study report
- Library Objects Modified in the Library report
- Number of Studies Containing Library Objects report
- Library Objects Modified in Studies report
- Study Baselines Difference report
- Studies Containing Selected Library Object report
- Workflow Rules and Global Conditions Report
- Generate an Annotated Study Book
-
Translate text
- View locale-specific translations in a layout
- Create, edit, translate, and remove a section note
- Edit and translate a form or section title
- Edit and translate a question for a locale
- Edit and translate a codelist item label override
- Enter and translate the title and short title of the Common Visit
- Translate the short title of a study event
- Translate the short title of a form
- Translate the question text of an item
- Translate a codelist item label
- Create and translate instructions and Help for a study design
-
11
Integrate Oracle InForm with Oracle Argus Safety
- About the Oracle InForm to Oracle Argus Safety integration
- Design Adverse Events, Safety Case, and other forms
- Add rules to forms for sending data to Argus Safety
-
Map Oracle InForm data items to Oracle Argus Safety entities
- Download the data mappings from My Oracle Support (MOS)
- Import the data mappings into Oracle Central Designer
-
Map Oracle InForm items to entities in Oracle Argus Safety
-
Mapping guidelines
- Include items that you map once in the Safety_Config data series
- Include items you want to monitor for changes to the Safety_Significant data series
- Map the data series to a specific instance of an item
- Map a form to multiple dynamic grids
- Map repeating data sets to items that can occur multiple times in a message
- Map items that include the unit in the item definition
- Map items coded in Oracle InForm
- Map items coded in Oracle Argus Safety
- Map to the MedDRA version
- Map narrative items
-
Predefined data sets included in the integration
- Safety_Case data set
- Subject data set
- Subject_AdverseEvent data set
- Subject_Autopsy data set
- Subject_CauseOfDeath data set
- Subject_ConMed data set
- Subject_Death data set
- Subject_Lab Test data set
- Subject_MedicalHistory data set
- Subject_PastDrugHistory data set
- Subject_SuspectDrug data set
- Subject_SuspectDrug_ReactionRecurrence data set
- Subject_SuspectDrug_ReactionRelatedness data set
- Reporter data set
-
Mapping guidelines
- (Optional) Create a custom data series
- Select the safety mapping (SafetyLogicalSchema) to deploy
- Set safety event data configuration options in Oracle InForm Publisher
- Supported post-production changes to a dynamic grid
-
12
FAQs
- User interface customization
-
Study setup
- How is a study's default locale used?
- How do I develop a study across multiple locales?
- How are float values formatted?
- Users Browser searches
- How does the Libraries tab search work?
- What does the Libraries tab search?
- What appears in my Libraries tab search results?
- Is there an easy way to find a study object and add it to the study design?
-
Study administration data
- What is study administration data?
- Where can I create study administration data?
- If I enter sponsor information in Oracle Central Designer, does it appear in the Oracle Central Designer Administrator?
- Where does sponsor information appear in Oracle InForm?
- What happens if I import study administration data that refers to study objects that aren't in the study I'm importing to?
- What happens if I import a study administration data object with the same identifier as an existing object in my study?
- What are review states?
- What type of file can I attach to a study as a reference?
- What size file can I attach to a study as a reference?
-
Coding setup
- What is a coding map?
- What is a verbatim?
- What is a context item?
- What is a target item?
- What is a query target item?
- Which dictionary types are installed with Central Designer?
- Can I add more than one version of a dictionary type?
- Can I associate multiple verbatim types with a single dictionary type?
- What are the requirements for coding components?
-
Library setup
- What is a library?
- What is the System Library?
- What happens if I unpublish an object in the library?
- About publishing, republishing, and unpublishing
- How can I use published study objects in workflows?
- Results of modifying study objects that have been copied to studies and libraries
-
What are examples of using
libraries effectively?
- Illustration: Example of a production library
- Illustration: Building libraries using study objects from production studies
- Illustration: Building libraries from scratch
- Illustration: Building a study using libraries
- Illustration: Modifying study objects in production libraries
- Illustration: Multiple instances of study objects in production libraries
- What is a template?
- What is a type?
- What is the difference between a template and a type?
- What information can I define for templates and types?
- About searching for a template or type
- What happens when I add a template to a study?
- What is an item type?
-
Import and export
- Why would I import or export study data?
- What data format can I import into Oracle Central Designer?
- What conditions must be met before a study object can be imported?
- Considerations for ODM import in Oracle InForm studies
- What modifications can I make to an imported study?
- What CMSL data is not exported or imported?
- What are the requirements for importing ODM metadata?
- How are ODM objects mapped to Oracle Central Designer objects?
- Can I export a single study object?
- Can I export and import text?
- What does a translator do with the exported text strings for translation?
- What is the format of the translation export and import CSV file?
- What are the requirements for the translation file?
- Tasks and notes
- Custom events
-
Rules
- What types of rules can I create?
- How should I name my rules?
- Can I schedule rules to run in a certain order?
- Can I create a rule with more than one action?
- What happens when I reuse a study object with a data-entry rule?
- What happens when I reuse a study object with a global condition?
- Which object should I add a rule to?
- What happens if I create a rule on a repeating study object?
- Should I use a workflow rule or a global condition?
- What happens if I disable a workflow?
- View all rules for a study object and its children
- Can I cause a subject to fail screening and enrollment?
- Partial SDV
-
Data mappings
- What is the difference between data mappings, data sets, and data series?
- How are data mappings deployed?
- How long do associations last?
- How are study objects that are part of a data mapping copied?
- What are the custom property settings and design rules for custom context panels?
- Mapping to a data series
- Mapping to a data set
- CDD mappings
- CIS mappings
-
Clintrial mappings
- How are data mappings generated for specialized Clintrial panels?
- How are data mappings deployed to Clintrial study objects?
- What are Clintrial subsets?
- How does Clintrial use subset keys and subset values in Oracle Central Designer?
- What is the difference between block keys and page keys in CIS data mappings?
- Data mappings vs rules
- Data mapping examples
-
Validation and deployment
- What's involved in study validation and deployment?
- Validation and deployment definitions
- How do the Oracle Central Designer study components appear in Oracle InForm?
- Validation
-
Deployment
- When can I create a deployment package?
- What types of deployment packages can I create?
- What happens when Oracle InForm processes the deployment package?
- When can I delete a deployment package?
- When can I cancel a deployment?
- What are the basics of automated deployment?
- What am I notified about during automated deployment?
- When should I use manual deployment?
- Can I edit or delete a deployment instance?
- How do I deploy an in-place revision?
-
Post-design activities
-
Decommissioning and archiving FAQs
- What's involved in decommissioning?
- What is the workflow for decommissioning studies and projects?
- What is archiving?
- What information is archived?
- How is deleting a study or project different from archiving?
- What information is deleted when you delete a study or project?
- What are the options for importing an archive?
- What information is imported from an archive?
-
Reports and Annotated Study Book FAQs
- What reports can I generate?
- What is an Annotated Study Book?
- What is in the Schedule of Events table in the Annotated Study Book?
- What do the RDE Analytics tables in the Annotated Study Book contain?
- How are layouts handled in an Annotated Study Book versus a deployment package?
- What are the RD Column names in RDE Analytics tables?
- What does the Custom Events table in the Annotated Study Book contain?
- Translating text FAQs
-
Decommissioning and archiving FAQs
-
Oracle InForm to Oracle Argus Safety integration
- What data does the integration require?
- Why would I make the Safety Case form dynamic?
- When might an Oracle InForm site user include multiple adverse events when sending data to Oracle Argus Safety?
- What is a dynamic grid?
- What are item level mapping and data point mapping in a dynamic grid?
- What is an editable item in a dynamic grid?
- When will an Oracle InForm site user use a Safety Case form?
- How do I include the unit of measurement with items I create in Oracle Central Designer?
- What's in the data sets used to process data transmissions?
- What is the syntax of the _SavetoDB function?
- How does a calculation rule work?
- Are there rules that are not supported for items in the dynamic grid?
- What happens in Oracle InForm when a source form with a dynamic grid is deleted?
- What kind of queries should I include on a dynamic grid item?
- What is data mapping?
- Are there fields that I don't need to map?
- When and how are data mappings validated?
- Which items have data series for transmitting coded or verbatim data?
- What alias names should I use when creating custom data series?
- How do I trigger Oracle InForm Publisher to send adverse event data to Oracle Argus Safety based on an onset date?
- General
-
13
What if...
-
Study administrators
- There are no locales listed on the Languages tab for my study
- I can't add a user to a study team
- I can't archive a study or project
- I was added to a study team, but still don't have the associated rights
- I can't find the dictionary type I want in the Dictionary Types list
- I can't find the verbatim type I want in the Verbatim Types list
- I can't deselect a dictionary type
- I can't add a library object to my study
- I can't search for study objects in a library that I want to search
- There aren't any sponsors listed in the study administration data
- I can't add a form to a signature group
- Library users
- Setting your machine for different locales
-
Dynamic grid
- I want to add one or more source items to a single target item
- Source items and target items have different data configurations
- The source item configuration differs from its parent form configuration
- I'm data mapping with a source item that has a codelist
- Source items have units
- I want to create multiple dynamic grids that have the same source form
- I'm using an item-level mapping for nested items
- I want to map multiple items in a repeating form to a single target item
- The year range differs between the source item and target item or form
- I can't import a project archive
- I export and re-import the same study CSML
- I can't create an item from a user-created type
- I can't mark a project as a template
- Deployment with an in-place revision change fails
- I delete a rule
- I deactivate a rule
- I disable a rule
- I can't disable a rule
- I cut a data-entry rule from a study object, but nothing happened
- A rule test case fails
- Validation produces errors and warnings
- A rule in Oracle InForm is deactivated
- I edit or delete a deployment instance
- There are blank pages in the PDF file created for my annotated study book
-
Study administrators
-
14
Option and property
descriptions
-
Setting up and administering a
study
- Home page—Section descriptions
- Status toolbar—Option descriptions
- Coding tab—Option descriptions
- Coding Map dialog boxes—Option descriptions
- Libraries tab—Section descriptions
- Libraries tab—Button descriptions
- References tab—Option descriptions
- Review State editor—Option descriptions
- Review State editor—Option descriptions
- Study General tab—Option descriptions
- Teams tab—Field descriptions
- Deployment Setup tab—Option descriptions
-
Study administration data
- Sponsor tab of the Administration editor—Option descriptions
- System settings tab of the Administration editor—Option descriptions
- Item Groups tab of the Administration editor—Option descriptions
- Query Groups tab of the Administration Editor—Option descriptions
- Rights Groups tab of the Administration Editor—Option descriptions
- Signature Groups tab of the Administration editor—Option descriptions
- Study elements and study events
- Study objects
-
Forms, items, codelists, and codelist items
- Codelists Editor—Option descriptions
- Codelist Items Editor—Option descriptions
- Design tab of the Codelist Editor—Option descriptions
- Design tab of the Form Editor or Section Editor—Option descriptions
- Design tab of the Item Editor—Option descriptions
- Forms and sections editor—Option descriptions
- General tab of the Form Editor or Section Editor—Option descriptions
- Oracle InForm Items Editor—Option descriptions
- Item Properties dialog box—Option descriptions
- Keys dialog box
- Languages tab of the Codelist Item Editor—Option descriptions
- Layouts
- Study workflow
- Import and export
- Tasks and notes
- Custom events
-
Rules
- Assign Conditions dialog box—Option descriptions
- Define Test Values for Repeating Instances dialog box—Option descriptions
- Design tab of the Rule Test Cases dialog box—Option descriptions
- Edit Global Conditions dialog box—Option descriptions
- Edit Schedule dialog box—Option descriptions
- Edit Schedule and Rule Action dialog box—Option descriptions
- Edit Workflow Rules dialog box—Option descriptions
- Email Action dialog box—Option descriptions
- Invoke Function dialog box—Option descriptions
- Query Action dialog box—Option descriptions
- New Rule Template dialog box—Option descriptions
- Rule Templates tab—Option descriptions
- Rule Wizard—Option descriptions
- Rules tab—Option descriptions
- Run tab of the Rule Test Cases dialog box—Option descriptions
- Set Review State Action dialog box
- Set Value Action dialog box—Option descriptions
- Workflow Expression Editor dialog box—Option descriptions
-
Data mappings
- Custom Dimension Labels - Select Codelist dialog box—Option descriptions
- Data Series Editor—Field descriptions
- Data Series Properties dialog box—Option descriptions
- Data Series Summary tab—Option descriptions
- Data Set Editor—Field descriptions
- Data Set Properties dialog box—Field descriptions
- Date-Time Data Point dialog box—Option descriptions
- Item has units dialog box—Option descriptions
- Mapping Editor—Field descriptions
- Select Custom Dimension dialog box—Option descriptions
-
Validation and deployment
- Baselines Browser—Option descriptions
- Create Deployment Package Wizard—Full deployment package
- Create Deployment Package Wizard—Incremental deployment package
- Create Deployment Package Wizard—Administration data deployment package
- Create Deployment Package Wizard—Custom events
- Deployment Editor—Option descriptions
- Pending Approvals tab on the Home Page—Option descriptions
- Deployment History dialog box—Option descriptions
- Deployment Package History dialog box—Option descriptions
- Deployment Request dialog box—Option descriptions
- Deployment Wizard for Oracle InForm deployment
- Jobs Browser—Option descriptions
- Post-design
-
Properties
- CDD data mapping properties
- CIS data mapping properties
- Codelist properties
- Codelist item properties
- Data mapping properties
- Data series standard properties
- Data set properties
- Form and section properties
- Item properties
- Study and library standard properties
- Study design properties
- Study element properties
- Study event properties
- Study project and library project properties
- Properties in the Rule Test Cases dialog box
-
Setting up and administering a
study