OpenClinica Documentation and Training Site

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
- 10 Importing Data
  - 10.1 Importing XML Files
  - 10.2 Importing Tabular Data
- 11 Completing Your Study
- 12 OpenClinica eConsent
- 13 OpenClinica Insight
  - 13.1 SQL Guide
  - 13.2 Front-end API Guide
  - 13.3 Insight Reporting Guide
- 14 OpenClinica Participate
- 15 OpenClinica Randomize
- 16 How and When to Use APIs
- 17 Knowledge Articles
  - 17.1 Generating Annotated eCRFs
  - 17.2 Suggested SOPs
- 18 Help Index
  - 18.1 Study Runner
    - 18.1.1 Submit Data
      - 18.1.1.1 Queries
    - 18.1.2 Monitor and Manage Data
    - 18.1.3 Extract Data
    - 18.1.4 Reports
  - 18.2 Study Designer
    - 18.2.1 Form Card
OpenClinica 3 User Documentation
OpenClinica 3 Technical Documentation
LMS FAQ's
Release Notes (OC4)
Release Notes (OC3)
Data Mart Guide

2.1 Create a Study

Who can create a study

Only users with a user type of Administrator and a user role of Data Manager can create a study. For information on user types and user roles, see User Access.

How to create a study

As an administrator, log into the OpenClinica study build system and click Add a new study.

The Add a new study window displays.

For definitions of the field, click Show Field Definitions, then hover over each of the fields to display the definition.

Enter values for each of the fields and click Save.

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