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OpenClinica 4 User Documentation
1 Administration
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 Getting Started
3.1 How to Get Help
3.2 For OC3 Users
3.3 Logging In
3.4 OpenClinica Basics
3.4.1 OpenClinica Navigation
3.4.2 The Participant Matrix
3.4.3 Adding a Participant
3.4.4 The Participant Details Screen
3.4.5 Events
3.4.6 Viewing and Entering Data on Forms
3.4.7 Your Home Screen
3.4.8 Managing Your Account
3.4.9 Frequently Used Screens
3.4.10 Frequently Used Terms
3.4.11 How to Log Out
4 Getting Data for Your Study: Reports and Extracts
4.1 Data Review Tables
4.2 Back-End Access Via Insight
4.3 Extract Data
5 Launching and Managing Studies
5.1 Publishing Your Study
5.2 User Access & Sharing
5.2.1 Using the Share Screen
5.2.2 Adding Sites
5.2.3 Inviting Users
5.2.4 Publish History
5.2.5 Editing Study Settings
5.2.6 Using Multifactor Authentication
6 Using OpenClinica as a CRC
6.1 Queries (CRC)
6.2 Add Participants
6.3 Entering Data
7 Using OpenClinica as an Investigator
7.1 Signing Participant Records
8 Using OpenClinica as a Monitor
8.1 Source Data Verification
8.2 Queries (Monitor)
9 Using OpenClinica as a Data Manager
9.1 Queries (Data Manager)
9.2 Source Data Verification
9.3 Reviewing and Managing Data
10 Importing Data
10.1 Importing XML Files
10.2 Importing Tabular Data
11 Completing Your Study
12 OpenClinica eConsent
12.1 eConsent for Participants
12.2 Configure eConsent Forms
12.3 eConsent in Study Runner
12.4 Activate eConsent
13 OpenClinica Insight
13.1 SQL Guide
13.2 Front-end API Guide
13.3 Insight Reporting Guide
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 Randomize
16 How and When to Use APIs
16.1 CDISC ODM XML
16.2 Clinicaldata (Import and Retrieve Clinical Data)
16.3 Participants (Add or Update a Participant)
16.4 Participants/Bulk (Add or Update Bulk List of Participants)
16.5 Retrieve Participant Contact Information
16.6 Events (Create and Update Single Study Event)
16.7 Bulk Create and Update Study Events
16.8 Bulk Actions Log
16.9 Participants (Get Participants at Study Level or Site Level)
17 Help Index
17.1 Study Runner
17.1.1 Submit Data
17.1.1.1 Queries
17.1.2 Monitor and Manage Data
17.1.3 Extract Data
17.1.4 Reports
17.2 Study Designer
17.2.1 Form Card
18 Knowledge Articles
18.1 Generating Participant Casebooks
18.2 Generating Blank CRFs
18.3 Generating Annotated eCRFs
18.4 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 2024
2 OpenClinica 4 – Release Notes 2023
3 OpenClinica 4 - Release Notes 2022
4 OpenClinica 4 - Release Notes 2021
5 OpenClinica 4 - Release Notes 2020
6 OpenClinica 4 - Release Notes 2019
7 Release Notes - OpenClinica Insight - 2019
8 OpenClinica 4 - Release Notes 2018
9 Release Notes - OpenClinica Insight - 2018
10 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
2 Building Forms and Studies
This section includes the following subsections:
2.1 Create a Study
2.2 Design a Study
2.3 Module Management
2.4 Form Library (CDASH)
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