Contents

About this guide Overview of this guide Audience Documentation Documentation accessibility If you need assistance Finding InForm information and patches on My Oracle Support Creating a My Oracle Support account Finding information and articles Finding patches Finding Oracle documentation Finding Oracle Health Sciences documentation Finding other Oracle documentation Finding prerequisite software for Oracle Health Sciences applications Introduction to the InForm Architect application InForm Architect application features Setting up new trials Enhancing existing trials Debugging The InForm Architect application and MedML About trial components Trial building blocks Starting with the Base trial Customizing Base trial data Learning with sample trials Planning a trial Planning forms Using annotated CRFs as a design tool Choosing the right controls Forms design tips Data type Form length Known value sets List size Nesting Edit checks Scrolling Developing forms libraries Planning edit checks Types of rules Client-side and server-side edit checks Generic and item-specific rules Dependencies Online help on edit checks Planning CRF help Planning data mappings Planning Customer-Defined Database mappings Planning user setup Planning reports Quick tour Overview Starting and stopping the InForm Architect application InForm Architect application window Trial Objects window Properties window Properties tab Mappings tab Output window Design Workspace Protocol Editor window Protocol tab MedML tab Form editor window Design tab of Form window MedML tab of Form window Dragging and dropping form components Cutting, copying, and pasting Element Editor window Elements tab MedML tab Rule editor window Rule Profile tab Script tab Test Cases tab MedML tab Execution Plan window Script tab MedML tab Data Mappings window Design tab Right-click menus Dragging and dropping mapped controls MedML tab Toolbars Main toolbar Edit toolbar Rules toolbar Trial toolbar Object Palette toolbar Settings toolbar Customizing the application workspace Customizing toolbars Displaying and hiding toolbars Rearranging positions Docking and undocking toolbars Choosing toolbar button appearance Customizing windows Displaying and hiding windows Docking and undocking windows Maximizing and restoring Using editing and navigation features Modifying trial components Changing trial order or composition Changing property definitions Using the Properties window Modifying element definitions Renaming a component Cutting, copying, and pasting Form component definitions Using the Microsoft Windows Clipboard method Duplicating objects in the Trial Objects window Restrictions Visit definitions Component properties Text strings Searching for text strings Searching for a text string Repeating a search Working with bookmarks Creating a bookmark Removing a bookmark Navigating among bookmarks Deleting trial components Setting up a trial Overview About trials Creating a new trial Opening an existing trial Design and production mode Closing a trial Inserting MedML into a trial Specifying additional paths Specifying strict MedML processing Installing the sample trial Saving a trial Saving a copy of the contents of an editor window Saving all components Saving active trial components Saving by component Installing trial component definitions in the database Working with a source control system Moving a trial into production Defining visits About visits Creating a new visit Creating a visit definition Defining visit properties Renaming a visit Reordering visits in a trial Deleting a visit from a trial Defining forms About forms Types of forms Form definition hierarchy Sections Itemsets Items Controls Defining components in the hierarchy RefNames Oracle reserved words UUIDs Position and caption properties Caption Caption Alignment Layout Design notes Creating a new form Creating a form definition Defining form properties Adding form subcomponents Managing forms and visits Adding a form to a visit Using the pop-up menu in the Protocol Editor Dragging and dropping the form Adding special forms to visits Transferring rule contexts Reordering a form in a visit Removing a form from a visit Defining a section Creating a new section Defining section properties Adding section subcomponents Including an existing section definition in a form Defining an item Creating a new item Defining item properties Adding controls to an item Including an existing item definition in a section Defining an itemset Creating a new itemset Defining itemset properties Adding items to an itemset Viewing the items in an itemset Including an existing itemset definition in a section Using key items Enhancing navigation in repeating forms Checking for data uniqueness Specifying separate unique keys Specifying key items for an itemset Specifying unique key combinations Defining controls Nesting controls Creating a new control�general instructions Using an existing control definition Defining a group, radio, or checkbox control Creating a new grouped control Defining grouped control properties Defining a pulldown control Creating a new pulldown control Defining pulldown control properties Defining a text box control Creating a new text box control Defining text box control properties Defining a date/time control Creating a new date/time control Defining date/time control properties Defining a calculated control Creating a new calculated control Defining calculated control properties Creating a calculation rule Defining a simple control Creating a new simple control Defining simple control properties Defining element components Creating an element definition Angle brackets in element values Navigating in the Element Editor window Defining units Creating a unit definition Example of conversion rule for Inches unit Example of conversion rule for Centimeter unit Annotating forms Annotated View Annotated Data Mappings Display Annotated Data Mappings Tables Display Selecting metadata for display Metadata in annotated CRFs Companion tables Element definition lists Data mapping tables Design notes Unit lists Electronic signature affidavits Time and Events Schedule Landscape print option Cover page Viewing the annotated trial design Printing the annotated trial design Setting up for printing Printing the active form Printing all forms in a trial Defining data mappings Overview About data mappings Two methods for creating data mappings Mapping data to a Customer-Defined Database About CDD mappings Setting up a CDD Types of CDD data transfer Transaction-based transfer Bulk transfer Designing CDD mappings Definitions of terms in CDD mappings Key types Pivot table key types Example - using pivot table keys Non-pivot table key types Example - using non-pivot table keys CDD mapping and generic visits Auto-generating CDD mappings Controlling column length for radio group mappings Mapping new forms to an auto-generated CDD Creating manual CDD mapping definitions Creating a CDD mapping definition object Creating a CDD mapping definition table Creating a CDD mapping definition table column Creating only a column definition Creating a column definition and mapping a control Using the Data Mappings window to create a column definition and control mapping Using the Form window to create a column definition and control mapping Defining CDD mapping table column properties Specifying properties for a control path Ordering columns in a table Mapping a form control Using the Data Mappings window to create a control mapping Using the Form window to create a control mapping Mapping associations to a CDD Association table schema definition Creating an association mapping manually Defining association mapping properties Mapping data to the Clintrial software Definitions of terms in Clintrial mappings Data mapping components CONTEXT panel mappings Working with additional CONTEXT panel items PANEL mappings ITEM mappings Control paths Autogeneration and manual definition Autogenerated mappings Autogenerated mappings and protocol imports Autogenerated mappings with the InForm Architect application Manual mappings Clintrial mapping and generic visits Setting up Clintrial data transfer processing Mapping considerations�InForm application to Clintrial software Autogenerating Clintrial mappings Overview of autogenerating mappings Creating an autogenerated mapping definition Mapping date time controls�Principles Mapping date time controls�Automatic mappings Mapping new forms to an autogenerated mapping definition Creating manual Clintrial mapping definitions Creating a Clintrial mapping definition object Mapping definition object properties Deleting a data mapping definition component Creating a panel mapping definition Panel mapping properties Creating a panel item mapping definition Creating only an item definition Creating an item definition and mapping a control Using the Data Mappings window to create an item definition and control mapping Using the Form window to create an item and control mapping definition Item mapping properties Creating a control path mapping definition Using the Data Mappings window to create a control mapping Using the Form window to create a control mapping Control path mapping properties Customizing Clintrial mappings Autogenerated codelists and mapping definitions Autogenerated codelists and the Code List property Autogenerated codelists and new mappings CONTEXT panel mappings CONTEXT panel item updates Updating a CONTEXT panel item Mapping date time controls�Manual mappings Creating mappings without a control path Modifying Clintrial Item Order in a panel Using page keys and block keys How CIS autogenerates page keys and block keys in the Clintrial software Customizing page keys and block keys Making panel property changes Panel properties you can change Changing panel properties Implementing Clintrial subsets Subsets in the Clintrial software Subset mapping properties Creating a type 0 panel Mapping autocoded data Autocode mapping workflow Differences between Autocode mapping and Central Coding mapping Creating an autocode mapping Specifying a source control Mapping data for coding with Central Coding Definitions of Central Coding mapping terms Central Coding mapping workflow Differences between Autocode mapping and Central Coding mapping Creating coding mapping definitions Creating a coding mapping object Coding mapping object properties Disabling a coding mapping object Identifying controls to be coded (verbatims) Specifying a RefName path to add a verbatim control mapping Dragging a control to add a verbatim control mapping Verbatim control mapping properties Changing a verbatim control path Verbatim control path restrictions Verbatim dictionary updates Removing a verbatim control mapping Identifying code targets Specifying a RefName path to add or update a code target path Dragging a control to add or update a code target path Code target mapping properties Code target control path restrictions Removing a code target path Identifying context items Specifying a RefName path to add or update a context item path Dragging a control to add or update a context item path Context item mapping properties Context item control path restrictions Removing a context item path Viewing coding mappings Expanding and collapsing the view of mappings General instructions for using the Build RefName tool Mapping data to Oracle Clinical Setting up Oracle Clinical processing About Oracle Clinical mappings Creating an Oracle Clinical mapping definition Defining a CPE Reference Defining the date of a CPE Reference Defining the time of a CPE Reference Defining the properties of a CPE Reference Defining a control mapping Displaying RefName paths for all controls Defining an individual control mapping Using the Data Mappings window to define an individual control mapping Using the Form window to define an individual control mapping Maintaining mappings Viewing mapping definition MedML Updating a data mapping definition Deleting a data mapping definition component Removing a mapping definition Viewing Data Mappings for a form control Viewing the form to which a control is mapped Viewing data mappings in annotated trial design Defining rules Overview About rules Rules and events Types of rules Conversions Calculations Form rules Randomization rules Browser and server rules About rule contexts Context types Generic form context Generic item context Specific visit context Context anatomy About arguments Types of arguments Writing scripts to use arguments Tip About rule dependencies Types of dependencies Applied Dependency Tip Trigger Considerations about additional dependencies Creating rules Creating a new rule definition Specifying rule properties Writing a rule script Using script editing features Rule script processing Conversion rules Form rules Calculation rules Randomization rules Defining default arguments Adding a default argument Modifying a default argument Removing a default argument Creating a context Dragging a rule onto a form Right-clicking the Contexts node Automatic context and dependency creation Viewing summarized context and dependency counts Viewing context type totals Viewing dependency totals for a specific context Specifying context-specific arguments and values Adding a context-specific argument Removing a context-specific argument Defining additional rule dependencies Removing a dependency Using the Build RefName tool General instructions for using the Build RefName tool Displaying the Build RefName dialog box Rule objects and methods Form rule and calculation script examples Calculation rule Form rule with dynamic query text Rule with arguments Checking for date/time control completion Randomization rule scripts Simple Central randomization Central Stratified randomization Simple Site randomization Stratified by Site randomization Testing rules Creating test data Running rule scripts against test data Running interactively Running selected test cases Running all test cases Using the RefName checker Running rule scripts against actual patient data Debugging rule scripts Rule script debugging examples Syntax error Test argument and variable values RefName checker Using the Patient.OutputDebug method Defining events and execution plans About events Creating events Creating a new event Specifying event properties Associating an existing event with a rule Creating an execution plan Execution plan objects and methods Examples of scripts that use execution plan objects Sending email to an InForm application user (???) Sending email to an internet user Getting a set of named values from the Patient object Sending a message to the Windows log Sending an email when a User is deactivated Debugging execution plans Using the Global.OutputDebug method Enabling specialized InForm application features Overview Alternate versions of forms Implementing an alternate form Example of implementing an alternate form Associations Overview Defining an association Including repeating forms in an association Right-clicking the association Dragging and dropping forms Coding dictionaries Coding dictionary XML Dictionary XML restrictions Dictionary XML updates Common forms Defining a common form When entry is not required Links to CRF Help Overview - Creating CRF Help links Creating a CRF Help bookmark Example Defining a HelpLink component Including a HelpLink component in a CRF Help document Example of a HelpLink to an CRF item help topic Example of a HelpLink to a CRF help topic Date display format Dynamic forms Overview - Implementing dynamic forms Creating a dynamic form in a visit Creating a dynamic form calculation Example of dynamic form calculation rule Removing a dynamic form Dynamic visits Overview - Implementing dynamic visits Creating a dynamic visit definition Creating a rule for selecting a dynamic visit schedule Example of a rule for a dynamic visit Example of a rule for a dynamic visit date Removing a dynamic visit Example of rule for removing a dynamic visit Monitoring forms Creating a Visit Report Creating a Regulatory Document Checklist Patient navigation mode Enabling patient navigation modes Patient ID information Patient Initials data entry item Patient Number data entry item Editable patient ID Recommendation for note in patient ID section Patient identification and patient record transfer Patient initials Patient numbers Rules on patient identification components Patient record transfer affidavit Customizing the patient record transfer affidavit Patient transfer affidavit XML Randomization Randomization sequences Example of a randomization sequence Drug Kit section and randomization control Randomization rule Example of a Simple Central randomization script Example of a Central Stratified randomization script Randomization source manager configuration Randomization sequence format configuration Randomization source database setup RANDOMIZATION table SOURCELISTS table DRUGKITS table Populating randomization source database tables Setting up Central Stratified randomization ODBC connection for the randomization database Creating an ODBC connection manually Configuring a randomization data source Creating an ODBC connection with PFAdmin Configuring the trial to use the randomization DSN Repeating forms Creating a repeating form Enhancing repeating form navigation Reports Calculations Date of Visit What if no date of visit is entered? What if the data of visit entered is later than the data entry date? Itemset column headers Required visits and items Study completion and dropout reason Study version acceptance dates Subject states Visit start hour Screening and enrollment forms Screening UUIDs Enrollment UUIDs Screening or enrollment copy calculation rule Using Patient Initials and Patient Number items Forms requiring signature Overview of implementing electronic signatures Creating the text of a signing affidavit Creating a signature group Associating a form with a signature group Signature invalidation Displaying a required signature list on a CRF Study Completion form Required Study Completion form components Visit Form Controls Elements Text resources Form design examples Separate study completion and noncompletion reason items Same item for study completion and noncompletion reason Unscheduled or repeating visits UUIDs Conflict visit Date Of Visit item Enrollment form Patient ID form Patient Initials item Patient Number item Randomization Regulatory Documents (Reg Docs) form Repeating visit and reporting DOV Screening form Screening section with Patient Initials Sequences Study Completion form Visit Report form Unit UUIDs Customizing predefined lists Overview of customizing predefined lists Customizing predefined lists Changing reason text for clearing a CRF or editing an item Changing query text Types of query text strings Performing trial administration activities Overview About InForm application administrators About administrative data Users Rights Trial activities and rights Groups Sites Events Rules Configuration information System Sponsors Sequence numbers Using the Admin tree in the Trial Objects window Managing users Creating a user Assigning or updating a user password Conforming to password standards Managing group assignments Adding a user to a group Removing a user from a group Managing site assignments Assigning rights to a user Removing rights from a user Updating user status From the Users detail page From the list of users Managing rights groups Creating rights groups Assigning users to rights groups Assigning display overrides to rights groups About display overrides Enabling rights group overrides Assigning or modifying rights group overrides Managing groups Types of groups Creating groups Assigning users to groups Creating item groups Assigning items to item groups Managing sites Creating sites Assigning users to sites Defining sponsors Creating a sponsor Managing numbering Creating sequence types Creating sequences Specifying sequence number format Sequence number codes Flag characters Type codes Examples Loading sequence number formats Defining system configuration settings Setting configuration parameters with SYSCONFIG Updating study definition data Overview Methods for updating the trial MedML tags for trial updates Creating new form versions Updating a study version Updating the STUDYVERSION tag Updating the STUDYVERSIONDOC tag Activating a study version Updating the STUDYVERSIONSITE tag Revising without updating the study version Revising a section on a form Revising an item on a form Metadata Update report Defining electronic trial documentation Overview Choosing an authoring tool Creating a trial protocol Modifying the trial protocol HTML files Creating a documentation definition XML file Examples of documentation definition XML files Trial protocol documentation definition CRF Help documentation definition Visit Calculator and Sample Case Book documentation definition Creating a Table of Contents file Example of a Table of Contents file Linking between document files Example of a complete link Example of a Table of Contents file with links Trial documentation and study versions Creating CRF Help Modifying CRF data entry help files Creating a FAQ placeholder Example: Creating a FAQ placeholder Creating a Rule Help placeholder Creating rule help text Example: Creating a Rule Help placeholder Revising trial documentation HTML Tags and Special Characters Overview HTML formatting tags HTML special characters Disallowed characters Creating custom reports About custom reports What is involved Output formats Text output formats Graphical output formats Data values, pie charts, and bar charts GROUP and INDEX assignments Graphical details of pie charts and bar charts Reporting COM object properties by function The Reporting COM object Creating custom text reports ASP basics for text reports Example 1 Example 2 Filtering data queries Sizing a table Associating data with a label Retrieving specific fields Requesting all users for a particular manager Requesting all sites for a particular user Simple text formatting Specifying date formats Creating custom graphs ASP basics for reports with graphics Filtering data for graphs Formatting graphics Sizing the display area Wrapping output to a new line Creating labels and legends Loading a custom report into InForm application Creating an XML file for custom reports Legal notices