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 |
Example 5: Incomplete 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 |
overview |
InForm administration pages and locales |
Overview of InForm administration |
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 |
InForm Portal |
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 |
automated deployment |
canceling |
deployment log file |
Deleting the deployment log |
Deployment Log dialog box |
Deployment log file |
Saving the deployment log |
Viewing the deployment log |
maintenance mode |
overview |
Deployment log file |
Maintenance mode |
Overview of automated deployment |
rights |
running |
scheduling |
user interface |
Deployment Log dialog box |
Deployment page |
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 |
chart types |
Chart configurations |
Choosing a chart type |
Types of charts |
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 |
Example 5: Incomplete 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 |
company logo |
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 |
criticality overrides |
description |
overview |
selecting |
selection criteria |
Considerations for selecting critical forms |
Forms not selected for SV |
critical items |
criticality overrides |
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 |
deployment, automated |
canceling |
deployment log file |
Deleting the deployment log |
Deployment Log dialog box |
Deployment log file |
Saving the deployment log |
Viewing the deployment log |
maintenance mode |
overview |
Deployment log file |
Maintenance mode |
Overview of automated deployment |
rights |
running |
scheduling |
user interface |
Deployment Log dialog box |
Deployment page |
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 |
Available online Help |
Documentation |
documents, InForm Portal |
audit trail |
editing |
making invisible |
overview |
restricting access |
updating |
uploading |
Before uploading a document |
Uploading a document |
dynamic control |
dynamic form |
dynamic visit |
E |
email |
address length |
change notification |
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 |
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 |
Home page |
InForm Portal |
Managing the InForm Portal Home page |
Setting the Home page for a user |
Updating the Home page with an HTML file |
overview |
setting up |
updating |
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 |
documentation |
overview |
About the Data Viewer |
About the InForm software |
About the Reporting and Analysis module |
Overview of this guide |
user interface |
users |
workflow |
InForm Portal |
audit trail |
documents |
Home page |
Managing the InForm Portal Home page |
Setting the Home page for a user |
Updating the Home page with an HTML file |
key contacts |
overview |
rights |
tabs and sections |
Tab types and InForm Portal pages |
Working with tabs and sections |
viewing |
integration user |
InForm users |
User details page |
item group |
creating |
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 contacts, InForm Portal |
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 |
InForm administration pages and locales |
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 |
log file, automated deployment |
deleting |
overview |
saving |
user interface |
viewing |
login |
accessing the user interface |
Logging in to the InForm application |
Logging in to the InForm application for the first time |
overview |
Inactive user messages |
Overview of logging in and passwords |
Reauthentication after a timeout |
passwords |
Guidelines for choosing a password |
Overview of logging in and passwords |
Password configuration options |
reauthentication |
user interface |
Change Expired Password page |
Change Password page—For InForm users |
Login page |
Reset Password page |
logo |
company |
study |
Loading a study logo |
Update Study Logo page |
logout |
M |
maintenance mode, automated deployment |
MedML |
custom review states |
overview |
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 |
documentation |
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 |
Set SV settings—Override settings dialog box |
criteria |
Checklist—Criteria for configuring Partial SV |
Considerations for selecting critical forms |
critical forms |
Considerations for selecting critical forms |
Critical forms |
Form criticality overrides |
Forms not selected for SV |
Set SV settings dialog box |
Set SV settings—Override settings dialog box |
critical items |
About the Critical All Forms Effective SV state |
Critical items |
Critical items—Effective SV states |
Item or itemset criticality overrides |
When item-level source verification takes effect |
criticality overrides |
overview |
Overview of source verification |
Partial source verification (Partial SV) |
study version and IPR changes |
Add or remove a form—For study version changes only |
Add or remove item from a form—For study version and in-place revision changes |
Study version and in-place revision changes and 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 |
Set SV settings—Override settings dialog box |
passwords |
assigning |
changing |
Changing your expired password |
Changing your password |
Renewing your credentials |
Resetting your password |
configuration options |
guidelines |
password - overview |
recovery |
Resetting your password |
Setting up your password recovery information |
resetting |
user interface |
Change Password page—For administrators |
Change Password page—For InForm users |
Reset Password page |
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 |
randomization rule |
reauthentication |
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 Firefox |
Browser settings for Internet Explorer |
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 |
InForm Portal |
navigation |
query |
rule |
study deployment |
user |
rights and rights groups |
creating |
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 |
sections, InForm Portal |
adding |
editing |
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 |
InForm users |
User details page |
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 |
Set SV settings—Override settings dialog box |
criteria |
Checklist—Criteria for configuring Partial SV |
Considerations for selecting critical forms |
critical forms |
Considerations for selecting critical forms |
Critical forms |
Form criticality overrides |
Forms not selected for SV |
Set SV settings dialog box |
Set SV settings—Override settings dialog box |
critical items |
About the Critical All Forms Effective SV state |
Critical items |
Critical items—Effective SV states |
Item or itemset criticality overrides |
When item-level source verification takes effect |
criticality overrides |
overview |
Overview of source verification |
Partial source verification (Partial SV) |
study version and IPR changes |
Add or remove a form—For study version changes only |
Add or remove item from a form—For study version and in-place revision changes |
Study version and in-place revision changes and 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 |
Set SV settings—Override settings 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 |
InForm users |
User details page |
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 |
logo |
Loading a study logo |
System administration rights |
Update Study Logo page |
stopping and starting |
study data locale |
How locales are applied in the InForm user interface |
Locales |
study deployment |
right |
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 logo |
loading |
right |
user interface |
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 |
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 |
Set SV settings—Override settings dialog box |
imported |
Imported subjects |
Set SV settings—Import subjects dialog box |
manual selection |
Manually selected subjects |
Set SV settings dialog box |
Set SV settings—Override 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 |
support user |
InForm users |
User details page |
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 |
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 |
tabs, InForm Portal |
activating |
creating |
deactivating |
naming |
reordering |
types |
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 |
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 |