Contents

Customize your workspace and the grid Customize the workspace Reset window layout and show hidden message boxes Show and hide the status bar at the bottom of the screen Choose what appears on startup Change the number of projects that appear in the Recent Projects list View more than one tab in the workspace Customize the data in a grid Filter data in a grid Remove a filter in a grid Group data in a grid Remove a grouping in a grid Select the columns that appear in a grid Arrange the columns in a grid Hide a column in a grid Sort data in a grid Create and configure a study Set up study parameters Create a study Choose the phase of a study Set the primary layout for a study Select the supported locales for a study Choose the default locale for a study Choose the libraries to make available to a study Set up study teams Add a user to a study team Remove a user from a study team Save a search in the Users tab Configure study administration data Import study administration data Enter study administration data Sponsor settings Select a study's sponsor Remove a study's sponsor System settings Configure system settings Restore the default system settings Delete system settings Item groups Create an item group and add items to it Remove items from an item group Query groups Create a query group Rights groups Create a rights group and add item groups to it Delete an item group from a rights group Signature groups Create a signature group Enter translation text for a signature affidavit Remove forms from a signature group Export study administration data for use in a user management tool (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 Select dictionary types and verbatim types for a study 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 user to a library team Remove a user from a library team Save a search in the Users tab 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 Step 1: Create an item to collect data on forms Step 2: Create a drop-down list or set of radio buttons or checkboxes (a codelist with codelist items) Step 3: Define sets of drop-down list options, radio buttons, or checkboxes Step 4: Require an item to use assigned codelists and subsets (Optional) 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 Import and export study objects Import study object into a library or study Import study objects View completed import jobs Importing translated text strings Checking for empty strings Export a study or library to a file Export a study or library Export text strings for translation Use tasks and notes to create collaboration Create and modify tasks and notes Create a task Create a collaboration note Change the assignees for a standard task Edit a task or collaboration note Delete a task or collaboration note Print a task or collaboration note Interact with assigned tasks View all tasks assigned to you Accept, unaccept, complete, close, or reopen a task Complete an assigned task 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 Import custom events that were created in InForm Publisher in a release prior to 6.2 Add a custom event from a library Deactivate a custom event Example of 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 Create and test rules Create rules Create an intrinsic rule Create a rule without a function Create a rule using a function Create a workflow rule in a workflow diagram Create a global condition Test rules Check rule syntax Write test cases for a rule or global condition Write a test case for a rule with an item on a repeating study object Run test cases Edit rules Modify a rule Deactivate a rule Delete a rule Disable or enable one or more rules Update the state of a workflow rule Disable a workflow rule Data mappings Use data mappings, data sets, and data series to associate items Create a data mapping Create a data set Create a data series Add an item to a data series by selecting a data series Add an item to a data series by selecting a study event or form Unmap an item mapping with a data series Change the data value associated with a data series Rule data mappings Modify labels of mapped custom data dimensions Delete a custom data dimension CDD mappings Create a data set to use for CDD mappings Map associated forms to a CDD Set up a pivot table with CDD data mappings Modify CDD date time part data mappings CIS data mappings and Clintrial subsets Set up data mappings for a Clintrial subset Create a custom Clintrial context panel Create a Clintrial enrollment panel Create a non-patient data (Type 0) panel ModifyCIS date time part data mappings Validate and deploy a study Before you begin: Make sure the workflow is valid Follow this four-step process Step 1: Validate the study to create the validation baseline Validate a study and create a baseline View baseline validation errors and warnings Resolve validation errors and warnings Ignore validation warnings Make repairs to the study Save validation messages to a CSV file Make a validation baseline public Step 2: Create a deployment instance Test the deployment instance Step 3: Create a deployment package from a validation baseline Create a deployment package: the basics Create a full deployment package Create an incremental deployment package Create an administration data deployment package Create a custom events deployment package View the deployment packages Delete a deployment package Step 4: Deploy the study to InForm Initiate automated deployment Set up the InForm environment Create a deployment request Obtain deployment approval, if required Cancel a deployment Viewing the history of deployments associated with your user account View the history of a deployment package Viewing and exporting the deployment log Initiate manual deployment Saving a deployment package Install the deployment package Install the study and update the rules Use the Deployment Wizard Use the command-line options Execute the deployment package Deployment command-line options Deployment ConfigFile options Sample deployment configuration file Perform post-design activities Lock and protect studies and libraries Lock or unlock a data-entry rule Lock or unlock a global condition Lock or unlock a workflow rule Lock a deployment instance Protect a study Protect and unprotect a library Archive and decommission a study Archive a study or project View errors associated with an archive View archived studies and projects Delete a study or project Download and import an archived study or project Delete an archived study or project from the database 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 Generate an Annotated Study Book Generate an Annotated Study Book Print an annotated study book Create a PDF file for an annotated study book Format dates on the Annotated Study Book for the Japanese locale Export the Schedule of Events table to a CSV file 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 Integrate InForm with Argus Safety Overview of Inform to Argus Safety integration What are adverse events? Overview of designing for integration Important study design considerations Step 1: Design Adverse Events, Safety Case, and other forms Step 1a: Design the Adverse Event form Step 1b: (Optional) Design other forms that may contain data to send to Argus along with the Adverse Event form Step 1c: Design a Safety Case form Create a section to collect related data (a dynamic grid) Step 2: Add rules to forms for sending data to Argus Safety Write a rule containing the SaveToDb function Step 2a: Add required rules to the Adverse Event form Send the Reportable or Serious item to Argus only when the InForm user marks it as Ready-to-Send Send the Reportable or Serious adverse event immediately upon form submission Calculate the sequence ID Send email to the safety group when an AE is marked as Serious or Significant Step 2b: Add rules to the Safety Case form (Required) Send a query if no adverse events are on the Safety Case form Copy values from an Adverse Event form to a Safety Case form Step 2c: Add rules for other forms containing adverse event items Check for multiple different death dates or patient autopsy completed codes Step 3: Map InForm data items to Argus Safety entities Step 3a: Download the data mappings from My Oracle Support (MOS) Step 3b: Import the data mappings into Central Designer Step 3c: Map InForm items to entities in Argus Safety Mapping guidelines Do this first: 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 InForm Map items coded in Argus Safety Map to the MedDRA version Map multiple AE forms 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 Map dosage frequency items in the 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 Map dosage frequency items in the Subject_SuspectDrug data set Subject_SuspectDrug_ReactionRecurrence data set Subject_SuspectDrug_ReactionRelatedness data set Reporter data set Step 3d: (Optional) Create a custom data series Step 4: Set safety event data configuration options in InForm Publisher Step 4a: Install InForm Publisher Step 4b: Configure the Argus Safety-only attributes FAQs User interface customization Can I arrange user interface elements? 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 Central Designer, does it appear in the Central Designer Administrator? Where does sponsor information appear in InForm? What happens if I import a study administration data object with the same identifier as an existing object in my study? What happens if I import study administration data that refers to study objects that aren't in the study I'm importing to? 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? What verbatim types can I use? 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 unprotect an object in a library that I copied to a study? What happens when I unpublish an object in a 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 is an item type? What happens when I add a template to a study? Import and export Why would I import or export study data? What data format can I import into Central Designer? What conditions must be met before a study object can be imported? Considerations for ODM import in 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 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 What are tasks and how do I work with them? Where do the task types come from? How are task statuses used? Who does what with tasks? What is a collaboration note? Custom events What are the limitations on triggers? 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? 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 What are my options when mapping an item to a data series? Which item data types are compatible with which data series? How are units of measurement mapped? Why are data dimensions the keys to viewing data? How does Central Designer process data series with unmapped items and without items? Mapping to a data set What are the standard data dimensions and data set methods? Why are data dimensions the keys to viewing data? CDD mappings What is a Custom-Designed Database (CDD)? Example�Creating a CDD mapping How data mappings are deployed to CDD tables What are the target key types for tables that do not pivot? What are the target key type for pivot tables? How can I map each drop-out reason to a separate CDD column? CIS mappings How do I set up CIS data mapping for date time items? 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 Central Designer? What is the difference between block keys and page keys in CIS data mappings? How are block key values assigned? How are page key values assigned? Data mappings vs rules Why should I use rules to create data mappings? When should I use a data mapping and when should I use a rule? How can I map to a specific instance of an item that appears multiple times in a study? Example of data mappings for rule creation Data mapping examples Different ways to set up data mappings What are the data mappings to create an SDTM model? How do standard versus custom dimensions change the view of the data? Validation and deployment What's involved in study validation and deployment? Validation and deployment definitions How do the Central Designer study components appear in InForm? Validation What is a baseline used for? What checks are performed during validation? What information is not validated? Can I delete a validation baseline? What happens to the baseline when you upgrade? Deployment When can I create a deployment package? What types of deployment packages can I create? What happens when 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 How can I switch between locales and provide translations? InForm to Argus integration What data does the integration require? Why would I make the Safety Case form dynamic? When might an InForm site user include multiple adverse events when sending data to Argus? How can I use a dynamic grid section on a form? When will an InForm site user use a Safety Case form? How do I include the unit of measurement with items I create in 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 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 InForm Publisher to send adverse event data to Argus based on an onset date? General What is a project? What happens when I delete a study object? What is the difference between an instance and a link? What happens when an instance is deleted? What happens when a link is deleted? What happens when I delete a study or project? What happens when I protect a study or library? How are study objects sorted in the Project Explorer? What are local locks and remote locks? What is the primary layout of a study? 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 I was added to a library team, but still don't have the associated rights I can't archive a library or library project I can't edit a library object I can't add a library to the Library List for a study I can't close a library that I'm not using anymore I can't delete an object Setting your machine for different locales Viewing Japanese characters Setting up a keyboard to use different locales Additional locale settings 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 InForm is deactivated I edit or delete a deployment instance 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 States 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 Elements editor�Option descriptions Study Events Editor Study objects Export Translations dialog box�Option descriptions Export Wizard options History Viewer dialog box�Option descriptions Import Wizard options - CSML or ODM file Import Wizard options - InForm resources References tab�Option descriptions 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 InForm Items Editor�Option descriptions Item Properties dialog box�Option descriptions Keys dialog box Languages tab of the Codelist Item Editor�Option descriptions Layouts Control Styles dialog box�Option descriptions Layout tab options and deployment to the InForm application Study Level Styles and Form Level Styles dialog boxes�Option descriptions Study workflow Common Visit tab of the Study Design Editor�Option descriptions General tab of the Study Event Editor�Option descriptions Schedule of Events tab�Option descriptions Workflow Diagram tab�Option descriptions Workflow Grid tab�Option descriptions Import and export Import Wizard options - CSML or ODM file Import Wizard options - InForm resources Translation file format Translation file requirements Export Wizard options Export Translations dialog box�Option descriptions Tasks and notes Task Editor dialog box�Option descriptions Collaboration Notes Browser�Option descriptions Collaboration Note Editor dialog box�Option descriptions Task areas�Field descriptions Tasks Browser�Option descriptions Custom events Custom Events editor�Option descriptions 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 InForm deployment Jobs Browser�Option descriptions Post-design In-place revisions IPR Configuration dialog box In-Place Revision Summary Editor�Option descriptions View Differences dialog box�Option descriptions IPR History dialog box�Option descriptions Annotated Study Book Annotated Study Book Options dialog box 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 Change log