Contents

CIS Overview Integrating InForm and Clintrial software About the InForm software Benefits of integration Study design and deployment Data entry and validation Data coding Data loading Data storage and analysis About the Clintrial software About integrated studies About integrated EDC-only studies About hybrid studies Integration architecture Overview of CIS architecture Design environment Production environment Load balancing Integrated study workflows Design environment workflow Designing with the Central Designer software Production environment workflow CIS Administration application CIS Administration Overview of CIS Administration Logging on to the CIS Administration application Common features of CIS Administration pages CIS Administration pages Menus Database users and System users in the CIS environment User accounts provided with the CIS software Customizing the CIS Administration application Overview of customizing the CIS Administration Viewing your user profile Managing My CIS user settings Overview of managing My CIS user settings Setting a home page and auto-refresh rate Managing your user profile Overview of managing your user profile Viewing or editing a My CIS user profile Changing your user password Registering InForm Adapters Overview of registering an InForm Adapter Registering an InForm Adapter Managing adapters Overview of managing adapters Filtering and sorting adapters in the adapter list Enabling and disabling Auto-refresh Viewing a list of InForm Adapters Adapter List page�Fields Managing InForm Adapters and end points Overview of managing InForm Adapters and end points Enabling or disabling auto-refresh for an InForm Adapter Changing the enabled state of an InForm Adapter Managing configuration settings Overview of configuration settings Viewing and changing general configuration settings Viewing and changing security settings Checking for adapter updates General tab of the Configuration page�Fields Security tab of the Configuration page�Fields Managing Security Overview of managing security Rights and roles in the CIS environment CIS synchronization page rights and assignments to default roles CIS central administration page rights and assignments to default roles Security Administration page Managing CIS users Overview of managing CIS users Viewing existing users Creating a new user Editing a user profile Changing the activation state of a user Viewing roles and associated domains for a user Changing roles associated with a user Managing roles Overview of managing roles Viewing a list of security roles Creating a new security role Changing a security role Administering synchronization connections Definition of synchronization Overview of synchronization connection administration tasks Viewing synchronization connections Overview of viewing synchronization connections Viewing a list of synchronization connections Enabling and disabling auto-refresh of a CIS Synchronization Adapter Filtering the synchronization connection list by status Sorting the synchronization connection list Sync Connections tab of the CIS Synchronization Adapter page�Fields Adapter tab of the Admin Adapter page�Fields Creating a synchronization connection Overview of setting up a connection Connections and time settings System date times Synchronization schedule time Dates and times in patient data Clintrial study book autocreation Overview of autocreating Clintrial study books Timing of study book autocreation Requesting immediate autocreation of a study book Clintrial panel and item autocreation Overview of autocreating Clintrial panels and items Creating a synchronization connection using the connection wizard Overview of creating a synchronization connection using the connection wizard Specifying how the synchronization connection communicates Identifying the Clintrial database instance Specifying a Clintrial protocol Selecting an InForm trial Specifying a schedule Reviewing and saving a new connection CIS Synchronization Connection Wizard�Connection Settings page�Fields CIS Synchronization Connection Wizard�Clintrial Instance page�Fields CIS Synchronization Connection Wizard�Clintrial Protocol page�Fields CIS Synchronization Connection Wizard�Schedule page�Fields Monitoring and editing synchronization connections Overview of monitoring and editing synchronization connections Viewing a summary of all CIS synchronization transactions Viewing synchronization error details for the last job Viewing all jobs for a specific synchronization connection Viewing error details for a job in the job history table Viewing and editing transactions Managing new mappings Viewing general information about a synchronization connection Viewing and changing settings for a synchronization connection Clearing the error cache Status tab of CIS Synchronization Connection page�Fields New Mapping Options view of CIS Synchronizations Status tab�Fields General tab of CIS Synchronization Connection page�Fields Settings tab of CIS Synchronization Connection page�Fields Viewing and changing global synchronization connection settings Overview of changing global synchronization connection settings Viewing and changing global synchronization connection settings Settings tab of the CIS Synchronization Adapter page�Fields Removing a synchronization connection Overview of removing a synchronization connection Removing a synchronization connection Managing email notifications Overview of managing email notifications Viewing email notification addresses Adding a new email address Editing an email address Disabling all email notifications Removing an email address Sending a test email notification Managing named synchronization schedules Overview of managing named synchronization schedules Viewing a list of named schedules Adding a named schedule Editing a named schedule Removing a named schedule Schedule view, Named Schedules tab, CIS Synchronization Adapter page�Fields Managing Clintrial database instances for synchronizations Overview of managing Clintrial database instances Viewing Clintrial database instances Adding a new Clintrial database instance Editing a Clintrial database instance Removing a reference to a Clintrial database instance CIS Synchronization Adapter Add Clintrial Database Instance page�Fields Manually starting or stopping a synchronization Overview of starting or stopping a synchronization manually Starting a synchronization manually Stopping a synchronization manually Monitoring and managing load balancing Overview of monitoring load balancing How the CIS software selects a processing machine Configuring CIS load balancing If problems occur during load balancing Machine failure Recovering from a machine failure Performing load balancing activities Viewing load-balancing machine status Taking a load-balancing machine off line Setting a load-balancing machine online INF_Tables Overview of INF_ tables INF_CODECONTROL Rows Columns INF_CODELIST Rows Columns INF_ERRORITEM Rows INF_ERRORITEM columns INF_ERRORITEM_AUDIT Rows Columns INF_ERRORLOG Rows Columns INF_ERRORSTATUS Rows INF_ERRORSTATUS columns INF_ERRORSTATUS_AUDIT Rows Columns INF_FORMSTATUS Rows Columns INF_ITEMINSTANCE Rows Columns FORMSTATE values INF_ITEMSTATUS Rows Columns INF_MSGEDIT_HISTORY Rows Columns INF_OBJECTS Rows Columns INF_OUTGOINGTRANSACTIONS Rows Columns INF_PANELINSTANCE Rows Columns INF_PATHMAP Rows Columns INF_PENDINGVALIDATIONS Rows Columns INF_PFELEMENT Rows Columns INF_RULE Rows Columns INF_SIMPLECONTROL Rows Columns INF_SITE_AUDIT, INF_SITE_DATA, INF_SITE_UPDATE Rows Columns INF_SUBJECT Rows Columns INF_STUDYVERSION INF_STUDYVERSION rows INF_STUDYVERSION columns INF_SUBJECT_AUDIT Rows Columns INF_TRANSACTION Rows Columns INF_TRANSACTIONDATA Rows Columns INF_USER_AUDIT, INF_USER_DATA, INF_USER_UPDATE Rows INF_USER_AUDIT, INF_USER_DATA, INF_USER_UPDATE columns CIS_Tables Overview of CIS_Tables CIS_LB_MACHINES CIS_LB_MACHINES rows CIS_LB_MACHINES columns CIS_SYNCH_JOBS_QUEUE CIS_SYNCH_JOB_QUEUE rows CIS_SYNCH_JOBS_QUEUE columns CIS_DEFAULT_PROPERTIES CIS_DEFAULT_PROPERTIES rows CIS_DEFAULT_PROPERTIES columns Data transfer and storage Overview of data transfer and storage Databases in the CIS system Clintrial database Important data structures in the Clintrial database Clinical data table structure InForm databases Important data structures in the InForm databases CIS databases Important data structures in the CIS database Data transfer summary Deletion and undeletion processing Audit processing General audit trail information Auditing in the Clintrial software Auditing in the InForm software Transaction edits Audit trail for manual transaction edits Suggested workflow for tracking manual transaction edits Troubleshooting and error messages Suggested troubleshooting procedure Environment configuration Synchronization connection definition Database statistics InForm and Clintrial data incompatibility Column size Data type CIS Error messages Page descriptions General administration pages Adapter List page Adapter List End Points view Configuration General Configuration Security Documentation List Profile My CIS Settings Register Adapters Wizard - Find Adapters page Register Adapters Wizard - Register Adapters page Register Adapters Wizard - Confirmation page Security administration pages Role - New Role Wizard Role Profile Role Rights Role Users Security Roles Security Users User - New User Wizard Profile User State User Roles Synchronization administration pages Add Clintrial Database Instance - Synchronization Add Named Synchronization Schedule Database Settings for synchronizations General Synchronization Information Load Balancing Named Schedules Notifications Settings Synchronization Connection Actions Synchronization Connection Job History Synchronization Connection Settings Synchronization Connection Status Synchronization Connection Status Error Details Synchronization Connection Status New Mapping Options Synchronization Connection Status Transaction Edit Synchronization Connection Wizard - Connection Settings Synchronization Connection Wizard - Clintrial Instance Synchronization Connection Wizard - Clintrial Protocol Synchronization Connection Wizard - InForm Trial Synchronization Connection Wizard - Schedule Synchronization Connection Wizard - Summary Synchronization Connection Wizard - Summary (Confirmation) Synchronization Connections