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 OpenClinica Navigation
    - 1.4.2 Your Home Screen
    - 1.4.3 Frequently Used Screens
    - 1.4.4 Frequently Used Terms
    - 1.4.5 The Participant Matrix
    - 1.4.6 Adding a Participant
    - 1.4.7 The Participant Details Screen
    - 1.4.8 Scheduling and Editing Events
    - 1.4.9 Events
    - 1.4.10 Viewing and Entering Data on Forms
    - 1.4.11 Status Icons
    - 1.4.12 Action Icons
    - 1.4.13 Understanding Contact Data
    - 1.4.14 Change Study
    - 1.4.15 Managing Your Account
    - 1.4.16 How to Log Out
- 2 Building Forms and Studies
  - 2.1 Create a Study
  - 2.2 Language Support
  - 2.3 Form Library (CDASH)
  - 2.4 Design a Study
  - 2.5 Module Management
  - 2.6 Automating Participant Access
- 3 Launching and Managing Studies
- 4 Using OpenClinica as a CRC
  - 4.1 Add Participants
  - 4.2 Entering Data
  - 4.3 Queries (CRC)
- 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 an Administrator
- 8 Using OpenClinica as a Data Manager
  - 8.1 Managing Sites
  - 8.2 Queries (Data Manager)
  - 8.3 Source Data Verification
  - 8.4 Reviewing and Managing Data
  - 8.5 Participant Audit Log
  - 8.6 Suggested SOPs
- 9 OpenClinica Recruit
- 10 OpenClinica Randomize
- 11 OpenClinica Consent
- 12 OpenClinica Participate
- 13 OpenClinica Code
- 14 OpenClinica Insight
- 15 Importing Data
  - 15.1 Importing XML Files
  - 15.2 Importing Tabular Data
- 16 How and When to Use APIs
- 17 Completing Your Study
- 18 Getting Data for Your Study: Reports and Extracts
- 19 Help Index
  - 19.1 Study Manager
    - 19.1.1 My Studies Page & Share Page
    - 19.1.2 Study Settings, User Roles, Modules
  - 19.2 Study Runner
    - 19.2.1 Monitor and Manage Data
    - 19.2.2 Reports
    - 19.2.3 Submit Data
      - 19.2.3.1 Queries
  - 19.3 Study Designer
    - 19.3.1 Events
    - 19.3.2 Form Card
OpenClinica 3 User Documentation
OpenClinica 3 Technical Documentation
LMS FAQ's
Release Notes (OC4)
Release Notes (OC3)
Data Mart Guide

5 Using OpenClinica as an Investigator

Before reviewing this section, make sure that you have read Getting Started. In addition, please review the Using OpenClinica as a CRC section, as the document applies to Investigators as well as CRCs.

For Information on Using OpenClinica as an Investigator, See the Following Section:

5.1 Signing Participant Records

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Revision History

Revision	Published	Approved By
Fixed typo	2025-07-15 12:59PM	Kate Lambert
Updated typos	2025-07-15 12:46PM	Kate Lambert
	2020-11-24 15:26PM	Kerry Tamm
	2020-11-19 13:14PM	Kerry Tamm
	2020-11-17 11:03AM	Kerry Tamm