Contents

CIS Overview Integrating InForm and Clintrial software About the InForm software About the Clintrial software Benefits of integration Study design and deployment Data entry and validation Data coding Data loading Data storage and analysis About integrated studies About integrated EDC-only studies About hybrid studies Integrated study workflows Design environment workflow Designing with the Central Designer software Production environment workflow CIS Administration application Planning an integrated study Reviewing user scenarios Developing study definitions for a hybrid study Deciding where to develop rules and calculations or derivations Comparison of Central Designer, Clintrial, and InForm rules Options for EDC data validation Validation and InForm enrollment Planning data mappings About data mappings Planning bulk data loads InForm Data Import utility Clintrial Manage or Lab Loader module Study component correspondences Working with integrated metadata Using integrated study metadata Creating a new hybrid study Adding metadata to an existing integrated study Modifying metadata in an existing hybrid study Clintrial protocol metadata Clintrial data record structure Context items System items Panel Types and context items Corresponding Clintrial and InForm metadata objects CONTEXT panel items Default CONTEXT panel item names Additional CONTEXT panel items Metadata from an InForm study Metadata in an integrated study Metadata in a hybrid study Data mappings Data type conversions Rules and derivations Codelists Codelists and synchronization Installing a study in the InForm database Working with data mappings Overview of data mappings What are data mappings? Data mapping components CONTEXT panel mappings PANEL mappings ITEM mappings Control paths Mapping data to the Clintrial software Setting up Clintrial data transfer processing Mapping considerations�InForm software to Clintrial software Clintrial mappings CIS mapping properties Mapping date time controls�Principles Working with mappings from the Central Designer software Customizing Clintrial mappings Autogenerated codelists and mapping definitions Autogenerated codelists and the Code List property Autogenerated codelists and new mappings CONTEXT panel mappings Context panel item updates Mapping date time controls Creating mappings without a control path Using page keys & block keys Block keys and page keys in CIS mappings How block key values are assigned How page key values are assigned Making panel property changes Panel properties you can change Implementing Clintrial subsets Creating a type 0 panel Mappings and coding targets Correcting a synchronization that generates warnings because of mapping to a Clintrial coding target Maintaining mappings Updating enrollment mappings Viewing data mappings in annotated study design Creating an integrated protocol Overview of creating an integrated protocol Integrated study development methodology summary Designing with the Central Designer software Clintrial study book autocreation option Study book autocreation terms Enrollment study book generation Non-patient data study book generation Patient data study book generation InForm study version data pass INF_PATHMAP pass Patient data panel pass Itemset generation Subset item generation Master-detail relationship generation Item generation Study book components not created Study book generation Possible problems during study book autocreation Clintrial panel and item autocreation option Configuring an integrated Clintrial protocol Required item attribute Rules and derivations DEPPs Page sections and page templates Codelists, aggregated or unaggregated Checklists Panel audit start date Updating a Clintrial protocol Updated protocols and the Resolve module Modifying updated protocols Entering data in an integrated study Overview of entering data Data transfer Patient number changes and synchronization Data entry in an EDC study Screening and enrollment Entering EDC data Merging EDC data Data entry in a hybrid study Managing queries and discrepancies Overview of managing queries and discrepancies in an integrated study What are queries and discrepancies? How are queries and discrepancies created? What are query and discrepancy states? How are queries and discrepancies resolved? Resolving queries in the InForm software and the Clintrial software Resolving queries generated by Clintrial rules in the InForm software Query response�Changing the data value Query response�Entering response text Queries and the Resolve module Clintrial rules that use data from more than one panel Handling of conflicts in query states Storage of query and discrepancy information Queries and discrepancies on frozen or locked forms Queries and discrepancies on an empty form Reopening of automatically closed queries Using rules in an integrated study Effect of rule location Validation and COMMIT statements Managing rules and queries in a hybrid study Duplicating rules Design considerations for creating Clintrial rules for a hybrid study Initial discrepancy status Mapping a discrepancy state to the Open InForm query state Editing a Clintrial database instance CIS processing for updated rules and derivations CIS processing for updated attachments to rules or derivations Modifying rules to ignore EDC data Placing queries on EDC items How CIS determines the item on which to place a query Loading error items into the INF_ERRORITEM table Validation and InForm enrollment Viewing merged query data Using Clintrial modules in an integrated study Overview of Clintrial modules in an integrated study The Clintrial software in integrated studies Clintrial changes Classify module Omissions status Solution types Design module Protocol design Protocol import and export Changing study mode Enter module Enrollment Data entry Manual discrepancies Flags and notes Lab Loader module Managing queries on batch loaded data Manage module Global Change and Global Delete Batch loading Managing queries on batch-loaded data Multisite Distribution module Test environment for Multisite Distribution and CIS Production environment for Multisite Distribution and the CIS software Multisite Distribution and CIS workflow Resolve module Setting up Resolve to return EDC queries Visibility of EDC queries