Contents

About this guide Overview of this guide Audience Documentation Documentation accessibility If you need assistance Finding InForm information and patches on My Oracle Support Creating a My Oracle Support account Finding information and articles Finding patches Finding Oracle documentation Finding Oracle Health Sciences documentation Finding other Oracle documentation Finding prerequisite software for Oracle Health Sciences applications InForm overview About the InForm application InForm users InForm system configuration Getting help Logging in and passwords Overview: Logging in and passwords Guidelines for choosing a password Password configuration options Logging in to the InForm application for the first time Logging in to the InForm application Inactive user messages Reauthentication after a timeout Changing your password Setting up your password recovery information Notification of email address change Resetting your password Changing your expired password Logging out of the InForm application Navigating Overview: InForm user interface Icons Audit trail icons Comment icons Form navigation icon Freezing and locking icons Query icons Patient navigation icons Required item symbol Reset value icon Select all checkboxes icon Status indicator icon on form tab Signature icons Source verification icon Visit and form status icons (traffic lights) Flag on status icon Document window Page indexer control Form indexer control Select Action list Links Using navigation shortcuts Most recently used pages Home page Go controls Navigation modes Visit navigation mode Dynamic visits and navigation modes Form navigation mode Dynamic forms and navigation modes Alternate forms and navigation modes Finding a patient by patient number Patient ordering Taking a quick tour Overview: Taking a quick tour Visiting CRC pages Starting the tour: User mmeyer Screening Log Case Books List Things to note Time and Events Schedule Things to note Case Report Forms Form views Summary view Detailed view Cross reference view Navigating between the form views Patient visit information Form item details Comments Queries Audit Trail Data Value(s) Form help Navigating between detail pages and forms Query Listing Trial documentation Overview: Trial documentation Protocol Form help Visit Calculator Sample Case Book Online help Logging off Visiting CRA pages Starting the tour: User mlynch Case Books List Things to note Time and Events schedule Things to note Source verification and monitoring screens Source Verification Listing SV Report SV Report print preview Visit Report Required Signatures list Reg Docs Logging off Screening Overview: Screening Accessing candidate information Screening a trial candidate What to do if... Submitting results in a screening failure Enrolling Overview: Enrolling Enrolling a trial candidate What to do if... Enrollment data is missing Enrollment is allowed with incomplete data Enrollment is not allowed with incomplete data Candidate does not meet trial criteria Candidate is ineligible Data entry error Enrollment failure override is permitted You do not want to enroll an eligible patient Entering form data Overview: Entering form data Form types Item types Data-entry controls Entering form data Form submitted successfully messages Entering a form comment Entering a comment on a form item Entering a comment on a form Associating forms Creating an association Adding an unscheduled visit What to do if... You find a data-entry error after submitting Complete data is unavailable A query is generated An item is inapplicable, unknown, or not done A form is not applicable, unknown, or not done An item is not editable or visible Updating form data Overview: Updating form data Data Value(s) page Audit trail Updating form data Clearing data Implications of clearing data Clearing data from an item Clearing data from a form Deleting or undeleting an itemset Deleting an itemset Undeleting an itemset What to do if... The new data item value results in a query Answering queries Overview: Answering queries Query status Appearance of items with queries Query Listing Queries page Ways to answer queries By changing the data value By submitting text Answering a query Changing the data value of the item Submitting answering text What to do if... The new data value results in another query Indicating source verification readiness Overview: Indicating that a form is ready for source verification Marking forms SV Ready or Not SV Ready Performing source verification About performing source verification Online source verification Source verifying data on an online form Ways to access the source verification view of a form Accessing the form from a case book Filtering for SV status in the Time and Events Schedule Accessing the form from the Source Verification Listing page Filtering the listing Public filters Custom filters Freezing or locking while monitoring Source verifying data from a printed listing Printing an SV Report for offline verification The Source Verification Listing page Source verification states What to do if... A form changes after source verification is complete Issuing queries Overview: Issuing queries Automatic and manual queries Query states Issuing a query Opening a candidate query Deleting a candidate query Navigating between queries and CRFs What to do if... You expect to see a query, but it is not there Closing queries Overview: Closing queries Closing queries Finding answered queries From the Query Listing From the Case Books list Closing the query How queries appear to sponsor users Opened queries Answered queries What to do if... The answer to a query is unacceptable Working with multiple queries Overview: Working with multiple queries Closing or reissuing a set of answered queries Opening or deleting a set of candidate queries Freezing, unfreezing, locking, and unlocking Overview: Freezing and locking Freezing and locking icons Freezing or locking a form Freezing or locking several forms at once All forms in a visit Selected repeating form instances While monitoring Freezing or locking a case book What to do if... Data changes after freezing or locking Signing forms Overview: Signing forms Significance of a signature Form and case book signatures List of required signatures Signature groups Invalidation of signature by data update Signing a CRF or case book Viewing signature status Viewing signature details What to do if... A form changes after signature Your signature fails processing Printing Printing a CRF Generating data listings Overview: Data listings Generating listings Creating a new listing Saving a listing specification Opening a saved listing specification Canceling a listing Deleting a listing Navigating from a listing to the source form Customizing a listing What to do if... You cannot download a listing Your session times out before a listing completes Using trial documentation Overview: Using trial documentation Viewing trial documentation Displaying help for a form Working with FAQs Adding a FAQ Editing a FAQ What to do if... Certain forms or items always cause confusion Using InForm online help Displaying online help Navigating InForm online help Using the Table of Contents Using the Index Using the Search tool Using other links Transferring patients Overview: Patient record transfer Audit history and patient record transfer archive Patient record transfer flow Patient status and record transfer Patient number conflicts Patient initials and DOB conflicts Patient transfer and study version Who can transfer patients? How to transfer patients Transferring one patient at a time If the current site is at a lower study version than the destination site If the current site is at a higher study version than all other sites If the InForm application finds a duplicate patient number at the destination site Viewing transferred patients Viewing the patient transfer audit trail Viewing a patient archive Contents of a patient archive Glossary Ad Hoc Reporting adverse event (AE) association audit trail case book case record form (CRF) clinical data clinical data manager (CDM) clinical project manager clinical reporting package clinical research associate (CRA) clinical research coordinator (CRC) clinical trial coding dictionary common form content pane content-specific pane control control path CRF help customer-defined database (CDD) design note display override dynamic form element event exclusion criteria execution plan expected form form generic rule home page inclusion criteria InForm Reporting and Analysis InForm Trial Management package Institutional Review Board (IRB) investigator itemset medical monitor navigation pane package protocol query RefName regular form repeating form rule rule dependency screening and enrollment serious adverse event signature group source verification sponsor standard report started form started visit SV Report trial trial management data trial-specific clinical model unscheduled visit visit visit calculator Legal notices