OpenClinica Documentation and Training Site

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 Viewing and Entering Data on Forms
    - 1.4.2 Your Home Screen
    - 1.4.3 Managing Your Account
    - 1.4.4 Frequently Used Screens
    - 1.4.5 Frequently Used Terms
    - 1.4.6 How to Log Out
    - 1.4.7 OpenClinica Navigation
    - 1.4.8 The Participant Matrix
    - 1.4.9 Adding a Participant
    - 1.4.10 The Participant Details Screen
    - 1.4.11 Events
- 2 Building Forms and Studies
  - 2.1 Create a Study
  - 2.2 Design a Study
    - 2.2.1 Content Library
    - 2.2.2 Create and Configure Data Review Tables
    - 2.2.3 Using the Form Template
    - 2.2.4 Events & Forms
    - 2.2.5 Using Form Designer
    - 2.2.6 Form Logic
    - 2.2.7 Functions
      - 2.2.7.1 OpenClinica Validated Functions Index
    - 2.2.8 Rules
    - 2.2.9 Locating Object Identifiers in a Study
  - 2.3 Language Support
  - 2.4 Form Library (CDASH)
  - 2.5 Module Management
  - 2.6 Automating Participant Access
- 3 Launching and Managing Studies
  - 3.1 User Access & Sharing
    - 3.1.1 Using Multifactor Authentication
    - 3.1.2 Publish History
    - 3.1.3 Editing Study Settings
    - 3.1.4 Using the Share Screen
    - 3.1.5 Adding Sites
    - 3.1.6 Inviting Users
  - 3.2 Publishing Your Study
  - 3.3 Generating Annotated eCRFs
  - 3.4 Generating Blank CRFs
- 4 Using OpenClinica as a CRC
  - 4.1 Entering Data
  - 4.2 Queries (CRC)
  - 4.3 Add Participants
- 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
  - 7.4 Suggested SOPs
- 8 Using OpenClinica as an Administrator
- 9 OpenClinica Recruit
- 10 OpenClinica Randomize
- 11 OpenClinica Consent
- 12 OpenClinica Participate
- 13 OpenClinica Insight
  - 13.1 Setting Up SAE Insight Report Alerts
  - 13.2 SQL Guide
  - 13.3 Front-end API Guide
  - 13.4 Insight Reporting Guide
- 14 Importing Data
  - 14.1 Importing XML Files
  - 14.2 Importing Tabular Data
- 15 How and When to Use APIs
- 16 Completing Your Study
- 17 Getting Data for Your Study: Reports and Extracts
- 18 Help Index
  - 18.1 Study Manager
    - 18.1.1 My Studies Page & Share Page
    - 18.1.2 Study Settings, User Roles, Modules
  - 18.2 Study Runner
    - 18.2.1 Monitor and Manage Data
    - 18.2.2 Reports
    - 18.2.3 Submit Data
      - 18.2.3.1 Queries
  - 18.3 Study Designer
    - 18.3.1 Events
    - 18.3.2 Form Card
OpenClinica 3 User Documentation
OpenClinica 3 Technical Documentation
LMS FAQ's
Release Notes (OC4)
Release Notes (OC3)
Data Mart Guide

1 OpenClinica 4 – Release Notes 2025

Draft OpenClinica 4 Stack 19.2.3 (Scheduled Release Date – 07 January 2025)

OpenClinica 4 Stack 19.2.3 contains targeted updates to OpenClinica. View the entire Stack 19.2.3 changelog here (login required). For an overview of this update, view the Stack 19.2.3 Release Announcement here.

Changes and Fixes:

Form Engine

Fixed an issue where individual printed form PDFs did not show values entered into date fields. This issue did not affect PDF Casebooks. (OC-23945)
Fixed an issue where the buttons to Add or Remove occurrences of repeating item groups in forms using the Grid layout were displaying with text labels instead of the intended “+” and “-” labels. (OC-23960)

For additional information on purpose, issues addressed, traceability matrix, and deviations please visit the OpenClinica 4 Stack 19.2.3 Note to File page here. (Coming Soon)

Click here to view previous updates.

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