| A |
| ad hoc report |
| accessing |
| Accessing the InForm Ad Hoc Reporting workspace |
| Opening an existing report |
| ad hoc reports - itemsets |
| Clinical report elements: forms and itemsets |
| Deleted itemset and form instances |
| Example 1: One non-repeating section and one itemset |
| Example 2: Incomplete non-repeating section and one itemset |
| Example 3: Incomplete non-repeating section, one itemset, and an additional form |
| Example 4: One non-repeating section with multiple itemsets |
| Itemsets, repeating visits, and repeating forms |
| Reporting on forms with itemsets |
| automatic summarization |
| Adding summary data to a report |
| Configuring automatic summarization settings |
| Summarization |
| creating |
| InForm Ad Hoc Reporting menu |
| InForm Ad Hoc Reporting tree |
| Using the InForm Ad Hoc Reporting tree to create reports |
| deleted report elements |
| drill up, drill down, drill through settings |
| editing |
| Changing the display format for report elements |
| Changing the page layout for a report |
| Editing tools in the InForm Ad Hoc Reporting workspace |
| Renaming titles and headings |
| Sorting data without adding a column |
| Sorting the elements in a report |
| element descriptions |
| Element descriptions |
| Study management report elements |
| filters |
| Adding a filter |
| Adding a filter without adding a column |
| Combining filters |
| Filter definitions |
| Removing a filter |
| Using predefined filters |
| identifying deleted data |
| lineage information |
| overview |
| previewing |
| Preview formats |
| Previewing report output with limited or no data |
| Using the design-time report viewer |
| Using the run-time report viewer |
| report options |
| Configuring automatic summarization settings |
| Report options for ad hoc reports |
| Run with advanced options for ad hoc and standard reports |
| Run with options for ad hoc and standard reports |
| running |
| Running an ad hoc report from the InForm Ad Hoc Reporting workspace |
| Running an ad hoc report in a new window |
| Running and saving ad hoc reports |
| saving |
| workspace |
| add entry |
| Feature comparison: Add Entry itemsets and Repeating Data itemsets |
| Item types |
| administration |
| MedML Installer utility |
| overview |
| rights |
| task list |
| affidavit |
| Overview of signatures |
| Transferring a subject |
| Viewing a print preview for a CRF or case report book |
| alternate form |
| assistance |
| associated form |
| attributes, queries |
| audience |
| audit trail |
| batch run rules |
| custom review states |
| Data Viewer |
| date/time conversion |
| partial SV |
| user interface |
| viewing |
| Displaying the Audit Trail page |
| Reviewing the audit trail |
| Audit Trail Report |
| description |
| Report/Graph page |
| selection criteria |
| audit trail reports |
| Audit Trail Report |
| Historical Login Report |
| B |
| batch run rules |
| batch run rules - audit trail |
| overview |
| Batch run rules |
| Frozen and locked case report books and batch run rules |
| Frozen and locked forms and batch run calculation rules |
| The audit trail and batch run rules |
| running |
| viewing |
| Viewing the details of batch run rules |
| Viewing the status of batch run rules |
| C |
| calculation rule |
| Select Rules to Run page |
| Types of InForm rules |
| calculations |
| calculations - date time elements |
| Calculating business days versus number of days |
| Calculations on date time elements |
| Dates with unknown date parts |
| creating |
| numeric elements |
| overview |
| About calculations and conversion rules |
| Calculations and conversion rules |
| string elements |
| candidate information |
| ineligible study criteria |
| Correcting a data-entry error |
| Refusing enrollment because the candidate does not meet eligibility criteria |
| What to do if a candidate does not meet study criteria |
| viewing |
| Accessing candidate information |
| Viewing the Enrollment form for a candidate |
| Viewing the Screening form for a candidate |
| Case Book Completion and Query Summary by Site report |
| description |
| Report/Graph page |
| selection criteria |
| Case Report Books page |
| description |
| Case Report Books page |
| Components—Case Report Books page |
| displaying |
| case report form |
| alternate form |
| description |
| Case report forms |
| Components—Case report form (CRF) pages |
| displaying |
| Displaying a single CRF |
| Displaying the CRFs for a visit |
| Working with CRFs |
| dynamic form |
| dynamic visit |
| form item details |
| form types |
| Form association |
| Form types |
| form views |
| icons |
| item types |
| navigating |
| Navigating from a CRF to the Data Viewer |
| Navigating from the Data Viewer to a CRF |
| Navigating through the CRFs in a visit without a mouse |
| Case Report Form (CRF) reports |
| CRF Aging by Site |
| CRF Cycle Time Detail by Site |
| CRF Cycle Time Detail for a Site |
| CRF Site Performance Summary by Site |
| CRF Status Detail by Site and Subject |
| CRF Status Detail by Visit and Site |
| CRF Status Summary by Site |
| CRF Status Summary by User |
| chart report |
| developing |
| overview |
| clinical data reports |
| associated forms |
| Example: Adverse Events and Concomitant Medications association |
| Reporting on associated forms |
| clinical and study management data |
| code report elements |
| date controls |
| default labeling |
| deleted itemsets and form instances |
| form index |
| forms and add-entry forms |
| incomplete data reasons |
| itemset index |
| itemsets, repeating visits, and repeating forms |
| Clinical report elements: forms and itemsets |
| Deleted itemset and form instances |
| Example 1: One non-repeating section and one itemset |
| Example 2: Incomplete non-repeating section and one itemset |
| Example 3: Incomplete non-repeating section, one itemset, and an additional form |
| Example 4: One non-repeating section with multiple itemsets |
| Itemsets, repeating visits, and repeating forms |
| Reporting on forms with itemsets |
| multi-instance forms and visits |
| About multi-instance forms and visits |
| Filtering reports with more than one multi-instance form or itemset |
| Reporting on multi-instance forms and visits |
| overview |
| Clinical data reports |
| Reporting on clinical data |
| reporting elements |
| units of measure |
| visit index |
| columns, Data Viewer |
| customizing |
| filtering |
| Column filter dialog box |
| Filtering data on clinical values for the current view |
| hiding or unhiding |
| reordering |
| resizing |
| setting names |
| user interface |
| Column filter dialog box |
| Configure Columns dialog box |
| comment report elements |
| Comment report elements |
| Comments |
| comments |
| displaying |
| entering |
| Entering a comment on a form |
| Entering a comment on a form item |
| Entering form data and comments |
| Entering row comments in a Repeating Data itemset |
| overview |
| user interface |
| Comment page |
| Itemset Row Comment page |
| Comments View, Data Viewer |
| components |
| displaying |
| overview |
| Comments View |
| Types of views in the Data Viewer |
| reviewing comments |
| Marking comments as reviewed |
| Reviewing comments |
| Reviewing comments across a single form and one or more subjects, visits, or sites |
| Reviewing comments across all forms |
| sorting |
| comments, Data Viewer |
| adding |
| exporting |
| Exporting comments to Excel |
| Exporting data to Excel |
| Overview of exporting data to Excel |
| marking as reviewed |
| reviewing |
| Marking comments as reviewed |
| Reviewing comments |
| Reviewing comments across a single form and one or more subjects, visits, or sites |
| Reviewing comments across all forms |
| user interface |
| common features, Data Viewer |
| column configuration |
| filters pane |
| pagination |
| toolbar |
| common form |
| components |
| Data Viewer |
| Components—Comments View |
| Components—Record Comparison View |
| Components—Record Listing View |
| InForm application |
| Components—Case Report Books page |
| Components—Case report form (CRF) pages |
| Components—Main user interface window |
| Components—Time and Events Schedule Form view |
| Components—Time and Events Schedule Visit view |
| conversion rule |
| CRF Aging by Site report |
| description |
| Report/graph page |
| selection criteria |
| CRF Cycle Time Detail by Site report |
| description |
| Report/Graph page |
| selection criteria |
| CRF Cycle Time Detail for a Site report |
| description |
| Report/Graph page |
| selection criteria |
| CRF icons |
| CRF item icons |
| CRF status icons |
| Visit and form status icons |
| CRF Item Listing report |
| description |
| Report/Graph page |
| selection criteria |
| CRF Site Performance Summary by Site report |
| description |
| Report/Graph page |
| selection criteria |
| CRF Status Detail by Site and Subject report |
| description |
| Report/Graph page |
| selection criteria |
| CRF Status Detail by Visit and Site report |
| description |
| selection criteria |
| CRF Status Summary by Site |
| description |
| Report/Graph page |
| selection criteria |
| CRF Status Summary by User report |
| description |
| Report/Graph page |
| selection criteria |
| critical form |
| description |
| overview |
| selecting |
| selection criteria |
| Considerations for selecting critical forms |
| Forms not selected for SV |
| critical items |
| effective SV states |
| About the Critical All Forms Effective SV state |
| Critical items—Effective SV states |
| overview |
| selecting |
| cross-reference view, forms |
| crosstab report |
| developing |
| overview |
| Cumulative Subject Enrollment by Month report |
| description |
| Report/Graph page |
| selection criteria |
| custom filter |
| creating |
| deleting |
| description |
| saving |
| custom groups |
| date time elements |
| defining |
| numeric elements |
| overview |
| string elements |
| custom review states, Data Viewer |
| assigning |
| defining |
| overview |
| Custom review states and the audit trail |
| Custom review states in the Data Viewer |
| Data Viewer review states |
| custom view, Data Viewer |
| creating |
| deleting |
| Deleting a custom view created with non-repeating forms and no itemsets |
| Deleting a custom view created with regular forms, repeating forms, or itemsets |
| displaying |
| overview |
| Itemsets and custom views |
| Overview of creating custom views |
| Repeating forms and custom views |
| Repeating visits and custom views |
| user interface |
| D |
| data display, Data Viewer |
| column customization |
| Column customization—Form Data Table |
| Column customization—Summary Data Table |
| column sorting |
| Column sorting—Comments View |
| Column sorting—Form Data Table |
| Column sorting—Summary Data Table |
| columns and headers |
| Locked columns and headers—Form Data Table |
| Locked columns and headers—Summary Data Table |
| filtering |
| Filtering data for all views in the Data Viewer |
| Filtering data on clinical values for the current view |
| Filters pane—Data Viewer |
| pagination |
| types |
| Detail Pane—Record Listing View |
| Form Data Table—Record Listing View |
| Summary Data pane—Record Listing View |
| Summary Data Table—Summary View |
| Data Value(s) page |
| Data Value(s) page |
| Displaying the Data Value(s) page |
| Data Viewer, about |
| custom review states |
| Custom review states and the audit trail |
| Custom review states in the Data Viewer |
| Data Viewer review states |
| Defining the Data Viewer custom review states |
| dates and times |
| InForm actions |
| overview |
| standard InForm states |
| Data Viewer, user interface |
| access rights |
| codes and code labels |
| components |
| Common Data Viewer features |
| Components—Comments View |
| Components—Record Comparison View |
| Components—Record Listing View |
| customizing |
| Customizing the columns in the Data Viewer |
| Customizing the Data Viewer workspace |
| Hiding or unhiding columns |
| Reordering column positions |
| Resizing a column |
| Setting the column names |
| filtering |
| Deleting a saved filter |
| Filtering data for all views in the Data Viewer |
| Filtering data on clinical values for the current view |
| Loading a saved filter |
| Modifying a saved filter |
| Saving a filter |
| icons |
| maximizing |
| navigating |
| Navigating from a CRF to the Data Viewer |
| Navigating from the Data Viewer to a CRF |
| Navigating from the Data Viewer to the Time and Events Schedule |
| Navigating from the Time and Events Schedule to the Data Viewer |
| normalized values |
| overview |
| Data Viewer user interface |
| Types of views in the Data Viewer |
| sorting |
| Column sorting—Comments View |
| Column sorting—Form Data Table |
| Column sorting—Summary Data Table |
| Sorting data in the Data Viewer |
| special cases |
| views |
| How the Data Viewer displays dates, visits, and form types |
| Types of views in the Data Viewer |
| Data Viewer, working with |
| assigning custom review states |
| Assigning a custom review state |
| Custom review states and the audit trail |
| Custom review states in the Data Viewer |
| comparing data |
| creating a custom view |
| displaying |
| Displaying the Comments View |
| Displaying the Record Comparison View |
| Displaying the Record Listing View |
| Displaying the Summary View |
| Working with the Data Viewer |
| exporting data |
| Exporting comments to Excel |
| Exporting data to Excel |
| Overview of exporting data to Excel |
| filtering |
| Filtering data for all views in the Data Viewer |
| Filtering data on clinical values for the current view |
| InForm states |
| overview |
| performing InForm actions |
| Assigning a custom review state |
| Creating a query in the Data Viewer |
| Freezing and unfreezing records in the Data Viewer |
| InForm actions available in the Data Viewer |
| Locking and unlocking records in the Data Viewer |
| Marking records Verified or Not Verified in the Data Viewer |
| Overview of performing InForm actions |
| Performing InForm actions |
| reviewing comments |
| Marking comments as reviewed |
| Reviewing comments across a single form and one or more subjects, visits, or sites |
| Reviewing comments across all forms |
| reviewing form data |
| Reviewing a single form across subjects, visits, or sites |
| Reviewing a single form for a single subject |
| Reviewing form data for started and expected forms |
| Viewing the details for a form |
| reviewing summary data |
| Reviewing summary data for a set of sites |
| Reviewing summary data for a set of visits |
| Reviewing summary data for started and expected forms |
| database columns |
| default values |
| date/time conversion |
| detailed view, forms |
| display override |
| assigning to rights groups |
| defining |
| item definition |
| overview |
| Display overrides |
| Overview of display overrides |
| user interface |
| Change Display Override in Rights Group page |
| User interface—Display overrides |
| user rights |
| documentation |
| dynamic control |
| dynamic form |
| dynamic visit |
| E |
| email |
| address length |
| enrollment data |
| Missing enrollment data |
| Overriding an enrollment failure due to incomplete data |
| Providing missing data and completing the enrollment |
| ENTER key |
| Components—Case report form (CRF) pages |
| Navigating through the CRFs in a visit without a mouse |
| ESC key |
| Components—Case report form (CRF) pages |
| Navigating through the CRFs in a visit without a mouse |
| event |
| modifying |
| overview |
| Events |
| Overview of events |
| Rules and events |
| user interface |
| Events detail page |
| Events page |
| User interface—Events |
| viewing |
| Viewing or modifying the details for an event |
| Viewing the list of events |
| expected forms, Data Viewer |
| common forms |
| description |
| Definition of Expected forms |
| How the Data Viewer displays dates, visits, and form types |
| display of |
| study completion |
| F |
| filters |
| custom |
| Creating a custom filter |
| Deleting a custom filter |
| Public and custom source verification status filters |
| Saving an applied custom filter |
| public |
| Public and custom source verification status filters |
| Selecting a public filter |
| filters, Data Viewer |
| creating |
| Filtering data for all views in the Data Viewer |
| Filtering data on clinical values for the current view |
| Saving a filter |
| deleting |
| loading |
| modifying |
| overview |
| saving |
| using |
| Filtering data for all views in the Data Viewer |
| Filtering data on clinical values for the current view |
| form |
| association |
| displaying |
| Displaying a single CRF |
| Displaying the CRFs for a visit |
| Working with CRFs |
| displaying, Data Viewer |
| entering a comment |
| Entering a comment on a form |
| Entering a comment on a form item |
| Entering row comments in a Repeating Data itemset |
| expected |
| Definition of Expected forms |
| Expected CRFs and common forms |
| Expected CRFs and study completion |
| types |
| form data |
| changing |
| Changing form data |
| Reviewing the audit trail |
| What to do if a new data item value results in a query |
| clearing |
| Clearing data |
| Clearing data from a form |
| Clearing data from an item |
| Implications of clearing data |
| creating associations |
| data-entry error |
| deleting |
| Deleting an Add Entry itemset after submission |
| Deleting an Add Entry itemset before submission |
| Undeleting an Add Entry itemset |
| entering |
| Entering form data |
| Entering form data and comments |
| incomplete data |
| items not visible |
| NA, unknown, or not done |
| Marking a form as skipped (a form is not applicable, unknown, or not done) |
| Marking an item as skipped (an item is not applicable, unknown, or not done) |
| overview |
| skipping |
| Marking a form as skipped (a form is not applicable, unknown, or not done) |
| Marking an item as skipped (an item is not applicable, unknown, or not done) |
| updating |
| About updating a form item on the Data Value(s) page |
| About updating form data |
| Updating form data |
| form data, Data Viewer |
| comparing |
| Comparing data |
| Comparing two clinical forms |
| exporting |
| Exporting data to Excel |
| Exporting data to Excel |
| Overview of exporting data to Excel |
| reviewing |
| Reviewing a single form across subjects, visits, or sites |
| Reviewing a single form for a single subject |
| Reviewing form data for started and expected forms |
| viewing details |
| form indexer |
| Components—Case report form (CRF) pages |
| Form indexer |
| form item details |
| Audit Trail page |
| Comment page |
| Data Value(s) |
| navigating between |
| Queries page |
| form rule |
| Select Rules to Run page |
| Types of InForm rules |
| form type |
| Form association |
| Form types |
| form view |
| cross-reference |
| detailed |
| navigating between |
| overview |
| summary |
| Form views |
| Using the summary view |
| Time and Events Schedule |
| form view, Time and Events Schedule |
| components |
| description |
| navigation |
| forms report elements |
| Aging |
| Cycle Times |
| description |
| Forms |
| Forms report elements |
| expected forms |
| Form Dates |
| Form Status Counts |
| freezing |
| case report book |
| data changes after |
| icons |
| overview |
| rules |
| several forms |
| Freezing or locking all forms in a visit |
| Freezing or locking several forms at one time |
| Freezing or locking while monitoring |
| Performing one freezing or locking action on several instances of a form |
| single form |
| while monitoring |
| freezing, Data Viewer |
| overview |
| InForm actions available in the Data Viewer |
| Overview of performing InForm actions |
| records in Data Viewer |
| G |
| Go controls |
| Components—Main user interface window |
| Using the Go controls on the study Home page |
| group |
| creating |
| MedML |
| modifying |
| Viewing or modifying the details for a group or item group |
| Viewing or modifying the users in a group |
| overview |
| Groups and item groups |
| Item groups |
| Overview of groups and item groups |
| types |
| user interface |
| Change Membership of Group page |
| Change Membership of Item Group page |
| Edit Group Properties page |
| Groups page |
| User interface—Groups |
| viewing |
| Viewing or modifying the details for a group or item group |
| Viewing or modifying the users in a group |
| Viewing the list of groups |
| H |
| help |
| Historical Login Report |
| description |
| Report/Graph page |
| selection criteria |
| I |
| icons |
| CRF |
| CRF item icons |
| CRF status icons |
| Visit and form status icons |
| Data Viewer |
| freezing and locking |
| overview |
| partial SV status |
| query status |
| signature status |
| visit status |
| inactive user messages |
| inactivity period |
| InForm application |
| administration |
| audience |
| configuration |
| overview |
| About the Data Viewer |
| About the InForm software |
| About the Reporting and Analysis module |
| Overview of this guide |
| user interface |
| users |
| workflow |
| item group |
| creating |
| MedML |
| modifying |
| Viewing or modifying the details for a group or item group |
| Viewing or modifying the items in an item group |
| overview |
| Item groups |
| Overview of groups and item groups |
| user interface |
| viewing |
| Viewing or modifying the details for a group or item group |
| Viewing or modifying the items in an item group |
| item report elements |
| description |
| Item report elements |
| Items |
| Item Counts by Property |
| Item Dates |
| Item Properties |
| Item Status Counts |
| item reports |
| CRF Item Listing |
| Source Verification Listing |
| item type |
| itemset |
| custom view |
| deleting |
| Deleting an Add Entry itemset after submission |
| Deleting an Add Entry itemset before submission |
| overview |
| Form types |
| Item types |
| types |
| undeleting |
| updating |
| K |
| key mapping |
| Components—Case report form (CRF) pages |
| Navigating through the CRFs in a visit without a mouse |
| L |
| locales |
| How locales are applied in the InForm user interface |
| Locales |
| locking |
| case report book |
| data changes after |
| icons |
| overview |
| partial SV and locked forms |
| rules |
| several forms |
| Freezing or locking all forms in a visit |
| Freezing or locking several forms at one time |
| Freezing or locking while monitoring |
| Performing one freezing or locking action on several instances of a form |
| single form |
| while monitoring |
| locking, Data Viewer |
| overview |
| InForm actions available in the Data Viewer |
| Overview of performing InForm actions |
| records in Data Viewer |
| login |
| accessing the user interface |
| Logging in to the InForm application |
| Logging in to the InForm application for the first time |
| overview |
| If you are automatically logged out |
| Inactive user messages |
| Overview of logging in and passwords |
| passwords |
| Guidelines for choosing a password |
| Overview of logging in and passwords |
| Password configuration options |
| user interface |
| Change Expired Password page |
| Change Password page—For InForm users |
| Login page |
| Reset Your Password Confirmation page |
| Reset Your Password page |
| logout |
| M |
| MedML |
| custom review states |
| groups and item groups |
| MedML Installer utility |
| overview |
| rights and rights groups |
| sites |
| system settings |
| users |
| mouseless user interface |
| Components—Case report form (CRF) pages |
| Navigating through the CRFs in a visit without a mouse |
| multilingual study |
| N |
| navigation |
| forms |
| Components—Case report form (CRF) pages |
| Form navigation—Form selectors |
| Navigating between detail pages and forms |
| Navigating between the form views |
| Go controls |
| Components—Main user interface window |
| Using the Go controls on the study Home page |
| search controls |
| Subject navigation mode |
| Subject search and navigation |
| Subject search mode |
| searching for subject |
| Finding a subject by subject number |
| Navigating among subjects |
| subject order |
| Changing the subject order in the Case Report Books page |
| Subject order |
| Time and Events Schedule |
| user interface |
| Case Report Books page |
| CRF pages |
| Time and Events Schedule |
| visits |
| Components—Case report form (CRF) pages |
| Visit navigation—Visit ruler and visit selectors |
| navigation, Data Viewer |
| CRF |
| Navigating from a CRF to the Data Viewer |
| Navigating from the Data Viewer to a CRF |
| Time and Events Schedule |
| Navigating from the Data Viewer to the Time and Events Schedule |
| Navigating from the Time and Events Schedule to the Data Viewer |
| O |
| offline source verification |
| Printing an SV Report for offline verification |
| Source verifying data from a printed listing |
| online Help |
| online source verification |
| overview |
| verifying data |
| Oracle |
| assistance |
| Outstanding Queries by Site and Visit report |
| description |
| Report/Graph page |
| selection criteria |
| P |
| page and row selectors |
| Components—Case report form (CRF) pages |
| Page and row selectors |
| partial SV |
| affect on InForm features |
| Audit trail and Partial SV |
| How Partial SV affects InForm features |
| Locked forms and Partial SV |
| Subject transfers and Partial SV |
| SV status icons and Partial SV |
| affect on status icons |
| audit history |
| Audit trail and Partial SV |
| Set SV settings—Audit History dialog box |
| checklist |
| configuring |
| Checklist—Criteria for configuring Partial SV |
| Configuring Partial SV |
| Set SV settings dialog box |
| criteria |
| Checklist—Criteria for configuring Partial SV |
| Considerations for selecting critical forms |
| critical forms |
| Considerations for selecting critical forms |
| Critical forms |
| Forms not selected for SV |
| Set SV settings dialog box |
| critical items |
| About the Critical All Forms Effective SV state |
| Critical items |
| Critical items—Effective SV states |
| When item-level source verification takes effect |
| overview |
| Overview of source verification |
| Partial source verification (Partial SV) |
| subjects |
| Automatically selected subjects |
| Excluded subjects |
| Imported subjects |
| Manually selected subjects |
| Subjects and the SV Pool |
| SV Required and study design |
| terminology |
| user interface |
| Set SV settings dialog box |
| Set SV settings—Audit History dialog box |
| Set SV settings—Import subjects dialog box |
| passwords |
| assigning |
| changing |
| Changing your password |
| Renewing your credentials |
| configuration options |
| guidelines |
| user interface |
| predefined filters |
| Adding a filter |
| Adding a filter without adding a column |
| Combining filters |
| Filter definitions |
| Filters |
| Predefined filters |
| Removing a filter |
| Using predefined filters |
| print |
| CRF |
| SV report |
| product locale |
| How locales are applied in the InForm user interface |
| Locales |
| public filter |
| Filtering the Source Verification listing |
| Public and custom source verification status filters |
| Selecting a public filter |
| Q |
| Queries details page |
| actions |
| Query—Action section |
| Query—Update Data and Answer |
| description |
| About working with queries |
| Queries detail page |
| Query workflow—For a site user |
| Query workflow—For a sponsor |
| displaying |
| icons |
| update and answer |
| Query—Action section |
| Query—Update Data and Answer |
| Query Aging by Site report |
| description |
| Query Aging by Site report - Report/Graph page |
| selection criteria |
| Query Cycle Times by Site report |
| description |
| Report/Graph page |
| selection criteria |
| Query Cycle Times by User report |
| description |
| Report/Graph page |
| selection criteria |
| Query Performance Summary by Site report |
| description |
| Report/Graph page |
| selection criteria |
| Query Performance Summary by User report |
| description |
| Report/Graph page |
| selection criteria |
| query report elements |
| Aging |
| Cycle Times |
| description |
| Queries |
| Query report elements |
| Properties |
| Query Counts |
| Query Dates |
| Query Status by Month, Year |
| query reports |
| Outstanding Queries by Site and Visit |
| Query Aging by Site |
| Query Cycle Times by Site |
| Query Cycle Times by User |
| Query Performance Summary by Site |
| Query Performance Summary by User |
| Query Status by Site |
| Query Status by Site and Subject |
| Query Status by Site and Visit |
| Query Status by User |
| Query Volume by Month by Site |
| Query Volume by Rule |
| Subject Counts with Outstanding Queries |
| Query Status by Site and Subject report |
| description |
| Report/Graph page |
| selection criteria |
| Query Status by Site and Visit report |
| description |
| Report/Graph page |
| selection criteria |
| Query Status by Site report |
| Report/Graph page |
| selection criteria |
| Query Status by User report |
| description |
| Report/Graph page |
| selection criteria |
| Query Volume by Month by Site report |
| description |
| Report/Graph page |
| selection criteria |
| Query Volume by Rule report |
| description |
| Report/Graph page |
| selection criteria |
| query, about |
| attributes |
| Appearance of items with candidate queries |
| Appearance of items with opened queries |
| Attributes of an automatically-generated query |
| hidden |
| icons |
| overview |
| About working with queries |
| Overview of queries |
| Query descriptions |
| query conflicts |
| states |
| types |
| user interface |
| Queries page |
| Query descriptions |
| Query Listing page |
| Query—Action section |
| Query—Data Value section |
| User interface—Queries |
| workflow |
| About working with queries |
| Query workflow—For a site user |
| Query workflow—For a sponsor |
| query, Data Viewer |
| answering |
| closing |
| icons |
| issuing |
| overview |
| query, working with |
| answering |
| Answering a query by changing the data value |
| Answering a query by submitting answer text |
| Answering queries |
| Appearance of items with answered queries |
| Finding answered queries from the Case Report Books page |
| Finding answered queries from the Query Listing page |
| What to do if the new data value results in another query |
| changing candidate to opened |
| closing |
| Appearance of items with answered queries |
| Closing a set of opened queries |
| Closing an answered query |
| Closing or reissuing a set of answered queries |
| Closing queries |
| deleting |
| Deleting a candidate query |
| Opening or deleting a set of candidate queries |
| finding |
| Finding answered queries from the Case Report Books page |
| Finding answered queries from the Query Listing page |
| issuing |
| Appearance of items with candidate queries |
| Appearance of items with opened queries |
| Issuing a query |
| Issuing queries |
| navigating |
| reissuing |
| Closing or reissuing a set of answered queries |
| Reissuing a query |
| update and answer |
| Answering a query by submitting answer text |
| Query—Update Data and Answer |
| viewing |
| Viewing the list of queries |
| Viewing the queries for a specific form item |
| working with multiple |
| Closing a set of opened queries |
| Closing or reissuing a set of answered queries |
| Opening or deleting a set of candidate queries |
| Working with multiple queries |
| R |
| randomization |
| overview |
| rules |
| Overview of rules |
| Types of InForm rules |
| randomization rule |
| Record Comparison View, Data Viewer |
| comparing data |
| Comparing data |
| Comparing two clinical forms |
| components |
| Components—Record Comparison View |
| Configure Columns dialog box |
| Filters pane—Data Viewer |
| Toolbar—Data Viewer |
| displaying |
| overview |
| Record Comparison View |
| Types of views in the Data Viewer |
| Record Listing View, Data Viewer |
| components |
| Components—Record Listing View |
| Configure Columns dialog box |
| Detail Pane—Record Listing View |
| Filters pane—Data Viewer |
| Form Data Table—Record Listing View |
| Forms pane—Record Listing View |
| Summary Data pane—Record Listing View |
| Toolbar—Data Viewer |
| data display |
| Detail Pane—Record Listing View |
| Form Data Table—Record Listing View |
| Summary Data pane—Record Listing View |
| displaying |
| overview |
| Record Listing Single Subject View |
| Record Listing View |
| Types of views in the Data Viewer |
| sorting |
| viewing data |
| Reviewing a single form across subjects, visits, or sites |
| Reviewing a single form for a single subject |
| Viewing the details for a form |
| regular form |
| repeating form |
| Form types |
| Repeating forms and custom views |
| Visit view—Repeating forms |
| repeating visit |
| report |
| ad hoc |
| About InForm Ad Hoc Reporting |
| Ad hoc reports |
| components |
| Components of a standard report |
| Report prompt page |
| Summary page |
| custom |
| data |
| overview |
| standard |
| Report prompt page |
| buttons |
| calendars |
| cascading prompts |
| checkboxes |
| drop-down lists |
| list boxes |
| overview |
| selection criteria |
| sort options |
| text boxes |
| report summary page |
| Report/Graph page |
| graphs and columns |
| report header and footer |
| show/hide report selections |
| Reporting and Analysis module |
| Configuring browser settings |
| Browser settings for Internet Explorer |
| Browser settings for Mozilla Firefox |
| navigating to |
| overview |
| rights |
| Reporting and Analysis portal |
| icons |
| Portal icons |
| Report output icons |
| overview |
| personal pages |
| New Page wizard |
| Personal pages |
| report folders |
| tools |
| reporting database |
| columns |
| data models |
| Data model security |
| Data models |
| InForm Trial Management package |
| internal IDs |
| About internal IDs |
| Internal IDs in the Clinical Data by Form folder |
| Internal IDs in the Trial Management data model |
| overview |
| Basic relational database concepts |
| Reporting and Analysis terminology |
| The Reporting and Analysis database |
| packages |
| reporting tree |
| Clinical reporting tree |
| InForm Ad Hoc Reporting tree |
| InForm Trial Management reporting tree |
| study-specific clinical package |
| reports, working with |
| adding comments |
| Adding a comment to a report |
| Comments in saved reports |
| enabling comments |
| opening |
| Opening a standard report in the Report Studio application |
| Opening an ad hoc report in Report Studio |
| overview |
| About InForm Ad Hoc Reporting |
| Ad hoc reports |
| Comparison of report types |
| Custom reports |
| InForm standard reports |
| previewing |
| Preview formats |
| Previewing report output with limited or no data |
| Using the design-time report viewer |
| Using the run-time report viewer |
| report options |
| Configuring automatic summarization settings |
| Report options for ad hoc reports |
| Report options for standard reports |
| Run with advanced options for ad hoc and standard reports |
| Run with options for ad hoc and standard reports |
| running |
| Running a standard report from the Reporting and Analysis portal |
| Running a standard report in a new window |
| Running an ad hoc report from the InForm Ad Hoc Reporting workspace |
| Running an ad hoc report in a new window |
| scheduling |
| New Job wizard |
| Run with options page for an existing job |
| Scheduling a single report |
| Scheduling multiple reports |
| Set Properties page for an existing job |
| review states, Data Viewer |
| assigning |
| defining |
| overview |
| Custom review states and the audit trail |
| Custom review states in the Data Viewer |
| rights |
| administration |
| case report book |
| CRF |
| Data Viewer |
| navigation |
| query |
| rule |
| user |
| rights and rights groups |
| creating |
| MedML |
| modifying |
| Viewing or modifying the rights in a rights group |
| Viewing or modifying the users in a rights group |
| overview |
| Overview of rights and rights groups |
| Rights and rights groups |
| rights for study activities |
| user interface |
| Change Members in Rights Group page |
| Rights Groups detail page |
| Rights Groups page |
| User interface—Rights and right groups |
| viewing |
| Viewing or modifying the rights in a rights group |
| Viewing or modifying the users in a rights group |
| Viewing the list of rights groups |
| rule |
| browser and server |
| contexts |
| Rules contexts |
| Types of InForm rule contexts |
| dependencies |
| Planning considerations—Rule dependencies |
| Rule dependencies |
| implementing |
| Implementing and deploying a rule |
| Rule implementation tools |
| modifying |
| overview |
| Batch run rules |
| Overview of rules |
| Rules |
| Rules and events |
| rights |
| running |
| types |
| Browser and server rules |
| Select Rules to Run page |
| Types of InForm rules |
| user interface |
| Batch Run Rules Status page |
| Rules detail page |
| Rules page |
| Rules Selected for Running page |
| Select Rules to Run page |
| Subject-Rules Status page |
| User interface—Rules |
| viewing |
| Viewing or modifying a rule |
| Viewing the list of rules |
| rule action |
| rule report elements |
| Rule report elements |
| Rules |
| S |
| sample case report book |
| screen and enroll |
| correcting data-entry error |
| enrolling |
| enrollment failure |
| Reasons for an enrollment failure |
| What to do if a candidate does not meet study criteria |
| ineligible study criteria |
| missing data |
| Missing enrollment data |
| Overriding an enrollment failure due to incomplete data |
| Providing missing data and completing the enrollment |
| What to do if a candidate does not meet study criteria |
| overriding a failure |
| overview |
| refusing enrollment |
| Refusing enrollment |
| Refusing enrollment because the candidate does not meet eligibility criteria |
| resubmitting candidate |
| screening |
| user interface |
| Enrollment form |
| Screening form |
| Screening Log |
| User interface—Screening and enrollment |
| Visit calculator (subject schedule) |
| section report elements |
| Properties |
| Section report elements |
| Sections |
| Select Action list |
| Components—Case report form (CRF) pages |
| Select Action list |
| signature |
| failing processing |
| form changes |
| Invalidation of signature by data update |
| When a form changes after signature |
| invalidation |
| Invalidation of signature by data update |
| When a form changes after signature |
| overview |
| Form and case report book signatures |
| List of required signatures |
| Overview of signatures |
| printing |
| requirements for signing |
| Before you sign a CRF or case report book |
| Signature groups |
| signature groups |
| signing |
| status icons |
| user interface |
| Required Signatures page |
| User interface—Signatures |
| viewing |
| List of required signatures |
| Viewing a print preview for a CRF or case report book |
| Viewing signature details |
| Viewing signature status |
| Viewing the signature status for all signatures |
| Viewing the signatures status for your signatures |
| site |
| changing site associations |
| modifying |
| Viewing or modifying site information |
| Viewing or modifying the members in a site (Changing site associations) |
| overview |
| Overview of sites |
| Sites |
| user interface |
| Change Members in Site page |
| Sites detail page |
| Sites page |
| Subject List for Site page |
| User interface—Sites |
| viewing |
| Viewing or modifying site information |
| Viewing or modifying the members in a site (Changing site associations) |
| Viewing the list of sites |
| Viewing the list of subjects at a site |
| site user |
| Site Visit Report |
| sites report elements |
| Sites |
| Sites report elements |
| sort order, Data Viewer |
| Column sorting—Comments View |
| Column sorting—Form Data Table |
| Column sorting—Summary Data Table |
| Sorting data in the Data Viewer |
| source verification |
| accessing forms |
| About accessing the source verification view of a form |
| Accessing the form from a case report book |
| Accessing the form from the Source Verification Listing page |
| filtering |
| About filtering the Time and Events Schedule for Source Verification status |
| Creating a custom filter |
| Deleting a custom filter |
| Filtering the Source Verification listing |
| Filtering the Time and Events Schedule for Source Verification status |
| Saving an applied custom filter |
| Selecting a public filter |
| form changes |
| freezing or locking |
| marking form SV ready or not SV ready |
| offline |
| Offline source verification |
| Printing an SV Report for offline verification |
| Source verifying data from a printed listing |
| online |
| overview |
| Overview of source verification |
| Partial source verification (Partial SV) |
| Site Visit Report |
| states |
| Source verification states |
| Verified form state |
| status filters |
| user interface |
| Regulatory Document Checklists page—Site list |
| Regulatory Documentation Checklist for a Site page |
| Site Visit Reports page |
| Source Verification Listing page |
| Source Verification Reports page |
| SV Report Print Preview page |
| User interface—Source verification |
| Visit Report for Site page |
| viewing listing |
| Source Verification Listing page |
| Viewing the source verification listing |
| Source Verification Listing report |
| description |
| Report/Graph page |
| selection criteria |
| source verification, Data Viewer |
| marking records verified or not verified |
| overview |
| InForm actions available in the Data Viewer |
| InForm states used in the Data Viewer |
| Overview of performing InForm actions |
| source verification, partial |
| affect on InForm features |
| Audit trail and Partial SV |
| Locked forms and Partial SV |
| Subject transfers and Partial SV |
| SV status icons and Partial SV |
| affect on status icons |
| audit history |
| Audit trail and Partial SV |
| Set SV settings—Audit History dialog box |
| checklist |
| configuring |
| Checklist—Criteria for configuring Partial SV |
| Configuring Partial SV |
| Set SV settings dialog box |
| criteria |
| Checklist—Criteria for configuring Partial SV |
| Considerations for selecting critical forms |
| critical forms |
| Considerations for selecting critical forms |
| Critical forms |
| Forms not selected for SV |
| critical items |
| About the Critical All Forms Effective SV state |
| Critical items |
| Critical items—Effective SV states |
| When item-level source verification takes effect |
| overview |
| Overview of source verification |
| Partial source verification (Partial SV) |
| subjects |
| Automatically selected subjects |
| Excluded subjects |
| Imported subjects |
| Manually selected subjects |
| Subjects and the SV Pool |
| SV Required and study design |
| terminology |
| user interface |
| Set SV settings dialog box |
| Set SV settings—Audit History dialog box |
| Set SV settings—Import subjects dialog box |
| special cases, Data Viewer |
| common forms |
| description |
| Definition of Expected forms |
| How the Data Viewer displays dates, visits, and form types |
| display of |
| expected forms |
| study completion |
| sponsor user |
| standard report |
| actions |
| components |
| data |
| folders |
| overview |
| InForm standard reports by category |
| Standard reports |
| report options |
| Report options for standard reports |
| Run with advanced options for ad hoc and standard reports |
| Run with options for ad hoc and standard reports |
| Report prompt page |
| running |
| Running a standard report from the Reporting and Analysis portal |
| Running a standard report in a new window |
| saving |
| Saving a standard report as a report view |
| Saving a standard report definition |
| Summary page |
| status icons |
| CRF |
| CRF item icons |
| CRF status icons |
| Visit and form status icons |
| Data Viewer |
| freezing and locking |
| overview |
| partial SV status |
| query status |
| signature status |
| visit status |
| study |
| locales |
| How locales are applied in the InForm user interface |
| Locales |
| stopping and starting |
| study data locale |
| How locales are applied in the InForm user interface |
| Locales |
| study design and reports |
| DOV controls |
| labels for clinical report elements |
| optional study elements |
| subject status requirements |
| study info report elements |
| sponsor |
| study |
| study versions |
| study locale |
| How locales are applied in the InForm user interface |
| Locales |
| study management data reports |
| comment report elements |
| forms report elements |
| item report elements |
| predefined filters |
| query report elements |
| rule report elements |
| section report elements |
| sites report elements |
| study info report elements |
| subject report elements |
| user info report elements |
| User Info report elements |
| User Info: Group Associations |
| User Info: Historical User Info |
| User Info: Users |
| visit report elements |
| study protocol |
| overview |
| viewing |
| study-specific documentation |
| displaying form help |
| overview |
| subject schedule |
| Viewing the visit calculator (subject schedule) |
| Visit calculator (subject schedule) |
| viewing |
| Viewing study-specific documentation |
| Viewing the sample case report book |
| Viewing the visit calculator (subject schedule) |
| visit calculator |
| Viewing the visit calculator (subject schedule) |
| Visit calculator (subject schedule) |
| Subject Counts with Outstanding Queries report |
| description |
| Report/Graph page |
| selection criteria |
| Subject Dropout Count by Reason report |
| description |
| Report/Graph page |
| selection criteria |
| Subject Enrollment Status by Site report |
| description |
| Report/Graph page |
| selection criteria |
| subject report elements |
| CRB StatusCounts |
| description |
| Subject report elements |
| Subjects |
| Subject Status (text) |
| Subject Status Counts |
| Subject Status Dates |
| subject reports |
| Case Book Completion and Query Summary by Site |
| Cumulative Subject Enrollment by Month |
| Subject Dropout Count by Reason |
| Subject Enrollment Status by Site |
| subject transfer |
| audit history |
| Audit history and subject record transfer archive |
| Viewing the audit trail for a transferred subject |
| changing subject number |
| conflicts |
| Number conflicts when transferring subjects with the InForm Data Import utility |
| Number conflicts when transferring subjects with the InForm user interface |
| Subject initials and DOB conflicts |
| Subject number conflicts |
| Subject transfer and study version |
| overview |
| Overview of subject transfer data |
| Overview of subject transfers |
| Subject transfers |
| Who can transfer subjects? |
| partial SV |
| resubmitting |
| study version |
| Resubmitting a subject transfer |
| Study version considerations when transferring subjects with the InForm Data Import utility |
| Study version considerations when transferring subjects with the InForm user interface |
| Subject transfer and study version |
| transfer archive |
| Contents of a subject transfer archive |
| Deleted items |
| Repeating forms |
| Viewing a subject transfer archive |
| transfer record |
| Subject record transfer flow |
| Subject status and record transfer |
| transferring |
| user interface |
| Site Audit Trail By Subject page |
| Subject Record Transfer page |
| Subject Transfer Status page |
| Transferred Subjects for Site page |
| User interface—Subject transfer data |
| User interface—Subject transfers |
| viewing |
| Viewing a subject transfer archive |
| Viewing the audit trail for a transferred subject |
| Viewing the list of transferred subjects |
| subjects |
| changing order |
| navigating |
| order |
| Changing the subject order in the Case Report Books page |
| Subject order |
| schedule |
| Viewing the visit calculator (subject schedule) |
| Visit calculator (subject schedule) |
| search |
| Subject navigation mode |
| Subject search and navigation |
| Subject search mode |
| searching for |
| subjects, partial SV |
| auto-selection |
| excluded |
| Excluded subjects |
| Set SV settings dialog box |
| imported |
| Imported subjects |
| Set SV settings—Import subjects dialog box |
| manual selection |
| Manually selected subjects |
| Set SV settings dialog box |
| overview |
| selecting |
| Checklist—Criteria for configuring Partial SV |
| Configuring Partial SV |
| summary page |
| Summary View, Data Viewer |
| components |
| Configure Columns dialog box |
| Filters pane—Data Viewer |
| Toolbar—Data Viewer |
| data display |
| displaying |
| Displaying the Summary View |
| Reviewing summary data for a set of sites |
| Reviewing summary data for a set of visits |
| Reviewing summary data for started and expected forms |
| overview |
| Data Viewer user interface |
| Summary View |
| Types of views in the Data Viewer |
| sorting |
| summary view, forms |
| Form views |
| Using the summary view |
| SV pool |
| auto-selection |
| excluded subjects |
| imported subjects |
| manual selection |
| overview |
| system configuration |
| InForm system configuration |
| Overview of system settings |
| System Configuration page |
| system information |
| System Information page |
| Viewing system information |
| system settings |
| configuration options |
| MedML |
| overview |
| Overview of system settings |
| System settings |
| stopping and restarting a study |
| user interface |
| System Configuration page |
| System Information page |
| User interface—System settings |
| viewing |
| T |
| Time and Events Schedule |
| displaying |
| filtering |
| About filtering the Time and Events Schedule for Source Verification status |
| Filtering the Time and Events Schedule for Source Verification status |
| form view |
| Components—Time and Events Schedule Form view |
| Time and Events Schedule—Form view |
| navigating |
| Navigating from the Data Viewer to the Time and Events Schedule |
| Navigating from the Time and Events Schedule to the Data Viewer |
| Time and Events Schedule navigation |
| overview |
| visit view |
| Components—Time and Events Schedule Visit view |
| Time and Events Schedule—Visit view |
| title bar |
| toolbar, Data Viewer |
| U |
| user info report elements |
| User Info: Group Associations |
| User Info: Users |
| user interface |
| components |
| Components—Case Report Books page |
| Components—Case report form (CRF) pages |
| Components—Main user interface window |
| Components—Time and Events Schedule Form view |
| Components—Time and Events Schedule Visit view |
| icons |
| navigating |
| Subject navigation mode |
| Subject search and navigation |
| overview |
| Case Report Books page |
| CRF pages |
| Main user interface window |
| Overview of the InForm user interface |
| Time and Events Schedule |
| sorting data |
| user interface, Data Viewer |
| Comments View |
| overview |
| Data Viewer user interface |
| Types of views in the Data Viewer |
| Record Comparison View |
| Record Listing View |
| Summary View |
| users |
| activating |
| Activating or deactivating a user |
| Activating or deactivating a user—From the User details page |
| Activating or deactivating a user—From the Users page |
| assigning |
| Assigning a password to a user |
| Assigning or modifying a user association to a rights group, site, and other groups |
| creating |
| deactivating |
| Activating or deactivating a user |
| Activating or deactivating a user—From the User details page |
| Activating or deactivating a user—From the Users page |
| description |
| MedML |
| modifying |
| overview |
| Overview of users |
| Users |
| reinstating |
| rights |
| terminating |
| user interface |
| Change Password page—For administrators |
| User details page |
| User interface—Users |
| Users page |
| viewing |
| Creating a user |
| Viewing or modifying the details for a user |
| V |
| verified form state |
| visit |
| adding unscheduled |
| displaying forms |
| navigating |
| Navigating through the CRFs in a visit without a mouse |
| Visit navigation—Visit ruler and visit selectors |
| overview |
| status icons |
| visit calculator |
| Viewing the visit calculator (subject schedule) |
| Visit calculator (subject schedule) |
| visit report elements |
| description |
| Visit report elements |
| Visits |
| Visit Counts by Property |
| Visit Dates |
| Visit Properties |
| Visit Status Counts |
| visit view, Time and Events Schedule |
| components |
| description |
| expand and collapse |
| navigation |
| repeating forms |
| W |
| workflow |
| X |
| XML |
| InForm administration and the MedML Installer utility |
| Overview of InForm administration |