OpenClinica Documentation and Training Site

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  • OpenClinica 4 User Documentation
    • 1 Getting Started
      • 1.1 How to Get Help
      • 1.2 For OC3 Users
      • 1.3 Logging In
      • 1.4 OpenClinica Basics
        • 1.4.1 OpenClinica Navigation
        • 1.4.2 The Participant Matrix
        • 1.4.3 Adding a Participant
        • 1.4.4 The Participant Details Screen
        • 1.4.5 Events
        • 1.4.6 Viewing and Entering Data on Forms
        • 1.4.7 Your Home Screen
        • 1.4.8 Managing Your Account
        • 1.4.9 Frequently Used Screens
        • 1.4.10 Frequently Used Terms
        • 1.4.11 How to Log Out
    • 2 Building Forms and Studies
      • 2.1 Create a Study
      • 2.2 Design a Study
        • 2.2.1 Using the Form Template
        • 2.2.2 Events & Forms
        • 2.2.3 Using Form Designer
        • 2.2.4 Form Logic
        • 2.2.5 Functions
          • 2.2.5.1 OpenClinica Validated Functions Index
        • 2.2.6 Rules
        • 2.2.7 Locating Object Identifiers in a Study
        • 2.2.8 Content Library
        • 2.2.9 Create and Configure Data Review Tables
      • 2.3 Module Management
      • 2.4 Form Library (CDASH)
    • 3 Launching and Managing Studies
      • 3.1 Publishing Your Study
      • 3.2 User Access & Sharing
        • 3.2.1 Using the Share Screen
        • 3.2.2 Adding Sites
        • 3.2.3 Inviting Users
        • 3.2.4 Publish History
        • 3.2.5 Editing Study Settings
        • 3.2.6 Using Multifactor Authentication
    • 4 Using OpenClinica as a CRC
      • 4.1 Queries (CRC)
      • 4.2 Add Participants
      • 4.3 Entering Data
    • 5 Using OpenClinica as an Investigator
      • 5.1 Signing Participant Records
    • 6 Using OpenClinica as a Monitor
      • 6.1 Source Data Verification
      • 6.2 Queries (Monitor)
    • 7 Using OpenClinica as a Data Manager
      • 7.1 Queries (Data Manager)
      • 7.2 Source Data Verification
      • 7.3 Reviewing and Managing Data
    • 8 Using OpenClinica as an Administrator
    • 9 Getting Data for Your Study: Reports and Extracts
      • 9.1 Data Review Tables
      • 9.2 Back-End Access Via Insight
      • 9.3 Extract Data
    • 10 Importing Data
      • 10.1 Importing XML Files
      • 10.2 Importing Tabular Data
    • 11 Completing Your Study
    • 12 OpenClinica Recruit
    • 13 OpenClinica eConsent
      • 13.1 eConsent for Participants
      • 13.2 Configure eConsent Forms
      • 13.3 eConsent in Study Runner
      • 13.4 Activate eConsent
    • 14 OpenClinica Participate
      • 14.1 Configure Forms for Offline Mode and Public URL
      • 14.2 Invite Participants
      • 14.3 Using Offline Data Capture
      • 14.4 Participant Data Entry
      • 14.5 Participate and the Audit Log
      • 14.6 Activate Participate
      • 14.7 Design Participate Forms
    • 15 OpenClinica Insight
      • 15.1 Setting Up SAE Insight Report Alerts
      • 15.2 SQL Guide
      • 15.3 Front-end API Guide
      • 15.4 Insight Reporting Guide
    • 16 OpenClinica Randomize
    • 17 How and When to Use APIs
      • 17.1 CDISC ODM XML
      • 17.2 Clinicaldata (Import and Retrieve Clinical Data)
      • 17.3 Participants (Add or Update a Participant)
      • 17.4 Participants/Bulk (Add or Update Bulk List of Participants)
      • 17.5 Retrieve Participant Contact Information
      • 17.6 Events (Create and Update Single Study Event)
      • 17.7 Bulk Create and Update Study Events
      • 17.8 Bulk Actions Log
      • 17.9 Participants (Get Participants at Study Level or Site Level)
    • 18 Help Index
      • 18.1 Form Designer
        • 18.1.1 Library Management
      • 18.2 Study Runner
        • 18.2.1 Submit Data
          • 18.2.1.1 Queries
        • 18.2.2 Monitor and Manage Data
        • 18.2.3 Extract Data
        • 18.2.4 Reports
      • 18.3 Study Designer
        • 18.3.1 Events
        • 18.3.2 Form Card
    • 19 Knowledge Articles
      • 19.1 Generating Participant Casebooks
      • 19.2 Generating Blank CRFs
      • 19.3 Automating Participant Access
      • 19.4 Generating Annotated eCRFs
      • 19.5 Suggested SOPs
  • OpenClinica 3 User Documentation
    • 1 Monitor and Manage Data
      • 1.1 Source Data Verification
        • 1.1.1 Verify Source Data
        • 1.1.2 Customize the View in Source Data Verification
          • 1.1.2.1 View by CRF or by Subject
          • 1.1.2.2 Find and Organize SDV Data
        • 1.1.3 View Source Data Verification Status
        • 1.1.4 Reset Source Data Verification Status
      • 1.2 Study Audit Log
        • 1.2.1 Audit Logs Page for a Subject
        • 1.2.2 What the Study Audit Log Tracks
      • 1.3 Manage Groups
      • 1.4 Manage CRFs
        • 1.4.1 Find and Organize CRFs
        • 1.4.2 View Original CRF and CRF Versions
      • 1.5 CRF Version Migration
        • 1.5.1 CRF Version Migration Screencast
    • 2 Extract Data
      • 2.1 Create Dataset
        • 2.1.1 Define Dataset
        • 2.1.2 Generate and Download Dataset
      • 2.2 View and Manage Datasets
        • 2.2.1 Access Dataset Definitions
        • 2.2.2 Archive of Exported Dataset Files
      • 2.3 Edit Dataset
      • 2.4 Download Datasets
        • 2.4.1 Browser Settings for Downloading Files
        • 2.4.2 Saving Downloaded Dataset Files
      • 2.5 Formats for Dataset Files
        • 2.5.1 Tab-Delimited Text Format
          • 2.5.1.1 Header Table Format
          • 2.5.1.2 Data Table Format
          • 2.5.1.3 Variable naming convention
        • 2.5.2 HTML Format
        • 2.5.3 Excel Spreadsheet Format
        • 2.5.4 SPSS Format
        • 2.5.5 Data Mart Format
        • 2.5.6 CDISC ODM Formats
        • 2.5.7 SAS Data and Syntax
      • 2.6 SPSS File Specifications
        • 2.6.1 SPSS Conceptual Mapping
        • 2.6.2 Creation of SPSS Data Definitions from OpenClinica CRF Item Properties
        • 2.6.3 Use of [EVENT HANDLE] and [CRF HANDLE] Appended to Variable Names
        • 2.6.4 Mapping between SPSS types and OpenClinica CRF ITEM Data Types
        • 2.6.5 Handling of OpenClinica Null values
        • 2.6.6 Mapping Between SPSS Values and OpenClinica RESPONSE_OPTIONS
          • 2.6.6.1 Syntax for VALUE LABELS
          • 2.6.6.2 SPSS Data Definitions for Built-in System Fields
      • 2.7 Data Mart (OpenClinica Enterprise Edition)
      • 2.8 Importing OpenClinica Data Into R
      • 2.9 Importing OpenClinica Data into STATA
    • 3 Study Setup
      • 3.1 View Study
      • 3.2 Build and Modify Study
        • 3.2.1 Status of Study
      • 3.3 Create Study Edit Details
        • 3.3.1 About Study Details
      • 3.4 Create and Modify Case Report Forms (CRFs)
        • 3.4.1 About CRFs in OpenClinica
        • 3.4.2 OpenClinica eCRF Specifications
          • 3.4.2.1 CRF Template - General Constraints
          • 3.4.2.2 Scope of CRFs and Items
          • 3.4.2.3 CRF Versioning
          • 3.4.2.4 CRF Template Properties
          • 3.4.2.5 CRF Template Elements
        • 3.4.3 Overview of Creating and Modifying CRFs
          • 3.4.3.1 About CRF Versions
        • 3.4.4 Designing CRFs
        • 3.4.5 Create a CRF
        • 3.4.6 Providing Content for a Defined CRF
        • 3.4.7 Upload a Defined CRF
        • 3.4.8 Table of CRFs
        • 3.4.9 Edit the Defined CRF Name and Description
        • 3.4.10 Create a New Version of a Defined CRF
          • 3.4.10.1 Replace a Defined CRF
          • 3.4.10.2 Add a New Version of a Defined CRF
        • 3.4.11 Remove, Restore, and Delete Defined CRFs
      • 3.5 Create and Modify Event Definitions
        • 3.5.1 Create Event Definitions
        • 3.5.2 View Event Definitions
        • 3.5.3 Edit Event Definitions
        • 3.5.4 Remove and Restore Event Definitions
      • 3.6 Create and Modify Subject Group Classes
        • 3.6.1 About Subject Group Classes
        • 3.6.2 Create Subject Group Class
        • 3.6.3 Edit Subject Group Class
        • 3.6.4 Remove or Restore Subject Group Class
      • 3.7 Create Rules
      • 3.8 Create and Modify Sites
        • 3.8.1 About Sites
        • 3.8.2 Create Site
        • 3.8.3 View Site Information
        • 3.8.4 Edit Site Information
        • 3.8.5 Remove or Restore Site
      • 3.9 Users and Roles at Current Study or Site
        • 3.9.1 View Users and Roles at Current Study or Site
          • 3.9.1.1 About User Information in the Study Setup Module
        • 3.9.2 Assign Users to Current Study or Site
        • 3.9.3 Change User Role at Current Study or Site
        • 3.9.4 Remove User from Current Study or Site
    • 4 Rules
      • 4.1 Definitions and Acronyms
      • 4.2 OID Overview
      • 4.3 Rules Applicability
      • 4.4 Creating Rules
        • 4.4.1 Rule Assignment and Rule Definition
        • 4.4.2 Expression Element
        • 4.4.3 Target Element
        • 4.4.4 Action Types
        • 4.4.5 Testing Expressions
      • 4.5 Manage Rules
        • 4.5.1 Manage Rules (Study Level)
        • 4.5.2 Export Rules
        • 4.5.3 Manage Rules (Item Level)
      • 4.6 Using Rule Designer
        • 4.6.1 Accessing Rule Designer
        • 4.6.2 Building Rules in Rule Designer
        • 4.6.3 Testing Rules in Rule Designer
      • 4.7 Rule Expressions
        • 4.7.1 Equal or Not Equal To
        • 4.7.2 Greater Than or Equal To
        • 4.7.3 Less Than or Equal To
        • 4.7.4 Arithmetic Operators
        • 4.7.5 6.7.5 The Contains Operator
      • 4.8 Rule Action Models
        • 4.8.1 ShowAction Models
        • 4.8.2 InsertAction Models
    • 5 Users and Roles
      • 5.1 About User Roles and Types
        • 5.1.1 User Types
        • 5.1.2 User Roles
      • 5.2 Permissions for User Roles and Types
        • 5.2.1 Summary of Features Available to User Roles
        • 5.2.2 Submit Data Module - Permissions
        • 5.2.3 Monitor and Manage Data Module - Permissions
        • 5.2.4 Extract Data Module - Permissions
        • 5.2.5 Study Setup Module - Permissions
        • 5.2.6 Administration Module - Permissions
        • 5.2.7 Module for Other Features - Permissions
      • 5.3 View, Assign, and Modify Users and Roles
      • 5.4 User Matrix
      • 5.5 Light Weight Directory Access Protocol(LDAP) Users
        • 5.5.1 LDAP/Active Directory Configuration
        • 5.5.2 Adding a LDAP User to OpenClinica.
    • 6 Administration
      • 6.1 Administer Studies
        • 6.1.1 Create a Study
          • 6.1.1.1 Re-Using Elements from One Study in Another Study
        • 6.1.2 Remove or Restore a Study
      • 6.2 Administer Users
        • 6.2.1 Create a New User
        • 6.2.2 About User Information in the Administration Module
        • 6.2.3 View and Modify User Information
          • 6.2.3.1 View User Information
          • 6.2.3.2 Edit User Information
          • 6.2.3.3 Change User Role
          • 6.2.3.4 Assign User to Study or Site and to Role
          • 6.2.3.5 Remove or Restore User
        • 6.2.4 Monitor User Access
        • 6.2.5 Configure Access to OpenClinica
          • 6.2.5.1 Set Lockout Feature
          • 6.2.5.2 Unlock a Locked-Out User
          • 6.2.5.3 Additional Password Configuration Options
          • 6.2.5.4 Configure Password Requirements
      • 6.3 Administer Subjects
        • 6.3.1 View Subjects in All Studies
        • 6.3.2 View Subject Details
        • 6.3.3 Edit Subject Details
        • 6.3.4 Remove and Restore Subject in System
      • 6.4 Administer CRFs
      • 6.5 Jobs
        • 6.5.1 Scheduled Import Jobs
          • 6.5.1.1 Create an Import Job
          • 6.5.1.2 View Scheduled Import Jobs
          • 6.5.1.3 Modify Scheduled Import Jobs
        • 6.5.2 Scheduled Export Jobs
          • 6.5.2.1 Create an Export Job
          • 6.5.2.2 View Scheduled Export Jobs
          • 6.5.2.3 Modify Scheduled Export Jobs
        • 6.5.3 View or Cancel Data Exports
    • 7 Printing CRFs
      • 7.1 Printing a Blank CRF or Blank Casebook
      • 7.2 Printing a Subject CRF or Subject Casebook
      • 7.3 Printing Tips
    • 8 OpenClinica Participate
      • 8.1 Activate and Build OpenClinica Participate for your Study
      • 8.2 Configure a Study for OpenClinica Participate
        • 8.2.1 OpenClinica Participate Forms
        • 8.2.2 Best Practices
      • 8.3 Connect Participants
      • 8.4 What if a Participant Can't Connect?
      • 8.5 Date Pickers
    • 9 OpenClinica Randomize
    • 10 OpenClinica Installation and Upgrade Guides
      • 10.1 System Requirements
      • 10.2 Install OpenClinica
      • 10.3 Install OpenClinica 3.4
      • 10.4 Install OpenClinica 3.3 on Linux
      • 10.5 Install OpenClinica 3.3 on Windows
      • 10.6 Upgrade to OpenClinica 3.3 on Linux
      • 10.7 Upgrade to OpenClinica 3.3 on Windows
      • 10.8 Install OpenClinica 3.2 on Linux
      • 10.9 Install OpenClinica 3.2 on Windows
      • 10.10 Upgrade to OpenClinica 3.2 on Linux
      • 10.11 Upgrade to OpenClinica 3.2 on Windows
      • 10.12 Install OpenClinica 3.1.x on Linux
        • 10.12.1 Overview of Installation on Linux Systems
        • 10.12.2 Operating System Requirements
        • 10.12.3 Download Installation Files
        • 10.12.4 Install Java
        • 10.12.5 Install Tomcat
        • 10.12.6 Install PostgreSQL Database
        • 10.12.7 Set Up the PostgreSQL Database
        • 10.12.8 Deploying OpenClinica within Tomcat
        • 10.12.9 Deploying OpenClinica Web Services within Tomcat
        • 10.12.10 Set Tomcat to Start
        • 10.12.11 Configure OpenClinica for Optimum Performance
        • 10.12.12 Configure the OpenClinica Application
        • 10.12.13 Configure the OpenClinica Web Services
        • 10.12.14 Description of datainfo.properties File
        • 10.12.15 Description of datainfo.properties File for Web Services
        • 10.12.16 Verify Access to OpenClinica
        • 10.12.17 Verify Access to OpenClinica Web Services
        • 10.12.18 Configure Tomcat to Use HTTPS
        • 10.12.19 Verify the Installation
      • 10.13 Install OpenClinica 3.1.x on Windows
        • 10.13.1 Overview of Installation on Windows Systems
        • 10.13.2 Software Dependencies and Operating System Requirements
        • 10.13.3 Install Java
        • 10.13.4 Install PostgreSQL Database
        • 10.13.5 Install Tomcat
        • 10.13.6 Install OpenClinica Package
        • 10.13.7 Install OpenClinica Web Services Package
        • 10.13.8 Set Up the PostgreSQL Database
        • 10.13.9 Configure Tomcat
        • 10.13.10 Configure OpenClinica for better Performance
        • 10.13.11 Configure the OpenClinica Application
        • 10.13.12 Configure the OpenClinica Web Services
        • 10.13.13 Start Tomcat
        • 10.13.14 Verify the Installation
        • 10.13.15 Verify the Installation of OpenClinica Web Services
      • 10.14 Upgrade to OpenClinica 3.1.x on Linux
        • 10.14.1 Overview of the Upgrade Process on Linux Systems
        • 10.14.2 Overview of the Upgrade Process for Web Services on Linux Systems
        • 10.14.3 Back Up OpenClinica
        • 10.14.4 Upgrade OpenClinica
        • 10.14.5 Upgrade OpenClinica Web Services
        • 10.14.6 Manual Database Updates
        • 10.14.7 Verify the Upgrade
        • 10.14.8 Verify the Upgrade for OpenClinica Web Services
      • 10.15 Upgrade to OpenClinica 3.1.x on Windows
        • 10.15.1 Overview of the Upgrade Process on Windows Systems
        • 10.15.2 Software Dependencies and System Requirements
        • 10.15.3 Back Up OpenClinica
        • 10.15.4 Manual Database Updates
        • 10.15.5 Verify the Upgrade
        • 10.15.6 Upgrade OpenClinica
        • 10.15.7 Back Up OpenClinica Web Services
        • 10.15.8 Verify the Upgrade for OpenClinica Web Services
        • 10.15.9 Upgrade OpenClinica Web Services
      • 10.16 OpenClinica VM Image
        • 10.16.1 Installing and Using VirtualBox
      • 10.17 Configuring an Oracle Database for OpenClinica (Deprecated)
        • 10.17.1 Set Up Oracle for OpenClinica Versions Pre-3.1.2
        • 10.17.2 Set Up Oracle for OpenClinica 3.1.2 or Above
      • 10.18 Operating System Installation
    • 11 Glossary
    • 12 Knowledge Articles
      • 12.1 Calculate Button
        • 12.1.1 Creating a CRF
        • 12.1.2 The Calculation Script
        • 12.1.3 Adding A Fancy Button
        • 12.1.4 Example Files
      • 12.2 Bulleted List
        • 12.2.1 Creating a Bulleted List
          • 12.2.1.1 Additional Tips
          • 12.2.1.2 Example Files
      • 12.3 Using the Decode() Function
      • 12.4 Partial Dates in OpenClinica
        • 12.4.1 Introduction to Partial Dates in OpenClinica
        • 12.4.2 Extracting Partial Dates in Data Mart
      • 12.5 HTML Tips to Enhance Your eCRF
    • 13 OpenClinica Community Tools and Tips
    • 14 OpenClinica Conference Presentations
    • 15 Submit Data
      • 15.1 Add Subject
        • 15.1.1 Add New Subject from Subject Matrix
        • 15.1.2 Add Subject from Tasks Menu
        • 15.1.3 Assign or Reassign Subject to Site
        • 15.1.4 Adding a Subject to More than One Study
      • 15.2 Schedule an Event
      • 15.3 View and Update Events
        • 15.3.1 View Events
          • 15.3.1.1 About the Events Table
        • 15.3.2 Update Events
        • 15.3.3 About the Event Status
        • 15.3.4 Electronic Signatures in OpenClinica
          • 15.3.4.1 Sign an Event
          • 15.3.4.2 Sign a Casebook (Entire Subject Record)
      • 15.4 Entering Data for an Event Into CRFs
        • 15.4.1 Enter Data Into a CRF
        • 15.4.2 CRF Unavailable
        • 15.4.3 Double Data Entry
        • 15.4.4 CRF Status
        • 15.4.5 Editing and Adding Data to Previously Saved CRF Sections
      • 15.5 Import Data
        • 15.5.1 Import the Data File
        • 15.5.2 Data File for Import
        • 15.5.3 Determine OIDs
          • 15.5.3.1 View Study Details to Determine OIDs
          • 15.5.3.2 View the Study Metadata File to Determine OIDs
        • 15.5.4 Create the Data Import File
        • 15.5.5 Validate and Check the Data Import File
        • 15.5.6 Example Data Import File
      • 15.6 Notes and Discrepancies
        • 15.6.1 About Discrepancy Notes
        • 15.6.2 Types of Discrepancy Notes
        • 15.6.3 Status of a Discrepancy Note
        • 15.6.4 Working with Individual Discrepancy Notes
          • 15.6.4.1 Create a Discrepancy Note
          • 15.6.4.2 View a Discrepancy Note
          • 15.6.4.3 Update a Discrepancy Note
        • 15.6.5 Manage Discrepancy Notes
          • 15.6.5.1 Notes and Discrepancies Table
          • 15.6.5.2 Actions to Take for Discrepancy Notes
          • 15.6.5.3 Organize and Find Discrepancy Notes
          • 15.6.5.4 Download Discrepancy Notes
      • 15.7 Remove, Restore, and Delete Study Events and CRFs for a Subject
        • 15.7.1 Remove and Restore Study Event CRFs for a Subject
        • 15.7.2 Delete Study Event CRFs for a Subject
        • 15.7.3 Remove and Restore Study Events for a Subject
        • 15.7.4 Delete Study Events
      • 15.8 Subject Matrix
        • 15.8.1 Overview of Subject Matrix
        • 15.8.2 View and Enter Event Data in Subject Matrix
        • 15.8.3 Show More Information About Subjects in Subject Matrix
        • 15.8.4 Find and Organize Data in Subject Matrix
        • 15.8.5 Actions for a Subject in Subject Matrix
        • 15.8.6 View Event Details in Subject Matrix
        • 15.8.7 View and Edit Details for a Subject in Subject Matrix
    • 16 Overview of OpenClinica
      • 16.1 Getting Started with OpenClinica
        • 16.1.1 Log In to OpenClinica
        • 16.1.2 Get a New Password
        • 16.1.3 Change Current Study or Site
        • 16.1.4 Update User Profile
        • 16.1.5 Log Out of OpenClinica
        • 16.1.6 Get Support
      • 16.2 OpenClinica Home Page
        • 16.2.1 Top of Page
        • 16.2.2 Navigation Bar
        • 16.2.3 Sidebar
          • 16.2.3.1 Status Icons
          • 16.2.3.2 Action Icons
          • 16.2.3.3 Complete Icon List
        • 16.2.4 Body of Home Page
        • 16.2.5 Bottom of Page
      • 16.3 Body of OpenClinica Home Page
        • 16.3.1 Data Manager and Study Director Home Page
        • 16.3.2 Investigator Home Page
        • 16.3.3 Monitor Home Page
        • 16.3.4 Data Entry User Home Page
        • 16.3.5 Data Specialist Home Page
        • 16.3.6 Clinical Research Coordinator Home Page
      • 16.4 Citing OpenClinica
  • OpenClinica 3 Technical Documentation
    • 1 REST Web Services
      • 1.1 OAuth and OpenClinica
      • 1.2 RESTful URLs
      • 1.3 RestFul URL access to OpenClinica metadata and print Resources.
      • 1.4 Read OpenClinica ODM Metadata REST Service
        • 1.4.1 Calling Methods and Arguments
        • 1.4.2 Responses
      • 1.5 Validate Rule REST Service
        • 1.5.1 Calling Methods and Arguments
        • 1.5.2 Responses
      • 1.6 Test Rule REST Service
        • 1.6.1 Calling Methods and Arguments
        • 1.6.2 Responses
      • 1.7 Save Rule REST Service
        • 1.7.1 Calling Methods and Arguments
        • 1.7.2 Responses
    • 2 SOAP Web Services
      • 2.1 Using OpenClinica Web Services
      • 2.2 StudySubject Web Service
        • 2.2.1 create (Creates a new studySubject)
        • 2.2.2 listAllByStudy (List studySubjects in a study)
        • 2.2.3 isStudySubject (Queries OpenClinica if studySubject exists in a Study)
      • 2.3 Event Web Service
        • 2.3.1 schedule (Schedules an event)
      • 2.4 Data Web Service
        • 2.4.1 Import
      • 2.5 Study Web Service
        • 2.5.1 getMetadata (Returns study metadata)
        • 2.5.2 listAll (Lists studies)
      • 2.6 StudyEventDefinition Web Service
        • 2.6.1 listAll (Lists study event definitions in study)
      • 2.7 Screencasts: Intro, Installation, and Usage Examples
    • 3 CRF Template Elements
    • 4 Database Schema
    • 5 Date Format Specifications
      • 5.1 Overview with Definitions and Acronyms
      • 5.2 DATE and PDATE Datatypes
        • 5.2.1 DATE Datatype
        • 5.2.2 PDATE Datatype (Complete Dates)
        • 5.2.3 PDATE Datatype (Month and Year Provided)
        • 5.2.4 PDATE Datatype (Year Provided)
    • 6 Item Data Specifications
      • 6.1 Item Properties
      • 6.2 Canonical Datatypes
    • 7 Internationalization and Localization
      • 7.1 Configure OpenClinica for Internationalization
      • 7.2 Install Desired Translations
      • 7.3 Translate OpenClinica into New Languages or Maintain Existing Translations
      • 7.4 Recommended steps to translate strings
      • 7.5 OpenClinica Data Extract File Format
    • 8 System Administration
      • 8.1 Configure Postgres to Allow Additional Connections
      • 8.2 Email Configuration and Troubleshooting Tips
      • 8.3 Backup and Restore OpenClinica
        • 8.3.1 Community Contributed Backup Scripts
      • 8.4 Loading the Demo Database
    • 9 Build a Data Extract or Reporting plug-in
    • 10 CDISC ODM Representation in OpenClinica
      • 10.1 CDISC ODM - General Issues
        • 10.1.1 Syntatic Constraints
        • 10.1.2 System Conformity
        • 10.1.3 Vendor Extensions
      • 10.2 Limitations on Support for Generated and Received ODM Files
      • 10.3 Entities and Elements
      • 10.4 OIDs and Clinical Data Keys
        • 10.4.1 Generation of OIDs
        • 10.4.2 OID Scope, Context and Uniqueness Constraints
        • 10.4.3 Clinical Data Keys
      • 10.5 File Properties, Transactions and Element Ordering
      • 10.6 Study Metadata Versions and Sites
      • 10.7 Data Representations in ODM XML (Extract)
      • 10.8 Data Representations in ODM XML (Import)
      • 10.9 Item Data Types
      • 10.10 Mapping of OpenClinica Elements to ODM
      • 10.11 CDISC ODM XML Schema
      • 10.12 Global Case Report Form in ODM repesentation
    • 11 Developing for OpenClinica
      • 11.1 Using the OpenRosa API in OpenClinica (experimental)
  • LMS FAQ's
  • Release Notes (OC4)
    • 1 OpenClinica 4 – Release Notes 2025
    • 2 OpenClinica 4 – Release Notes 2024
    • 3 OpenClinica 4 – Release Notes 2023
    • 4 OpenClinica 4 - Release Notes 2022
    • 5 OpenClinica 4 - Release Notes 2021
    • 6 OpenClinica 4 - Release Notes 2020
    • 7 OpenClinica 4 - Release Notes 2019
    • 8 Release Notes - OpenClinica Insight - 2019
    • 9 OpenClinica 4 - Release Notes 2018
    • 10 Release Notes - OpenClinica Insight - 2018
    • 11 OpenClinica 4 - Release Notes 2017
  • Release Notes (OC3)
    • 1 Release Notes – OpenClinica 3.17
    • 2 Release Notes - OpenClinica 3.16
    • 3 Release Notes - OpenClinica 3.15
    • 4 Release Notes - OpenClinica 3.14
    • 5 Release Notes - OpenClinica 3.13
    • 6 Release Notes - OpenClinica 3.12
    • 7 Release Notes - OpenClinica 3.11
    • 8 Release Notes - OpenClinica 3.10
    • 9 Release Notes - OpenClinica 3.9
    • 10 Release Notes - OpenClinica 3.8
    • 11 Release Notes - OpenClinica 3.7
    • 12 Release Notes - OpenClinica 3.6
    • 13 Release Notes - OpenClinica 3.5
    • 14 Release Notes - OpenClinica 3.4.1
    • 15 Release Notes - OpenClinica 3.4
    • 16 Release Notes - OpenClinica 3.3
    • 17 Release Notes - OpenClinica 3.2
    • 18 Release Notes - OpenClinica 3.1.4.1
    • 19 Release Notes - OpenClinica 3.1.4
    • 20 Release Notes - OpenClinica 3.1.3.1
    • 21 Release Notes - OpenClinica 3.1.3
    • 22 Release Notes - Older Releases
  • Data Mart Guide
    • 1 Accessing Data Mart on OpenClinica Optimized Hosting
    • 2 Accessing the Data Mart Local Deployment
    • 3 How We Set Up Your Data Mart
    • 4 Setting Up a PostgreSQL Server for Data Mart
    • 5 Working with the Data Mart
      • 5.1 System Architecture for Data Mart
      • 5.2 Loading Data into the Data Mart
      • 5.3 Data Mart Schema for Study
      • 5.4 Data Types
      • 5.5 SQL Joins for Related Tables
      • 5.6 Reporting Status of CRFs and Events

5 Working with the Data Mart

5.1 System Architecture for Data Mart
5.2 Loading Data into the Data Mart
5.3 Data Mart Schema for Study
5.4 Data Types
5.5 SQL Joins for Related Tables
5.6 Reporting Status of CRFs and Events

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