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 Recruit
- 13 OpenClinica eConsent
- 14 OpenClinica Participate
- 15 OpenClinica Insight
  - 15.1 SQL Guide
  - 15.2 Front-end API Guide
  - 15.3 Insight Reporting Guide
- 16 OpenClinica Randomize
- 17 How and When to Use APIs
- 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
- 19 Knowledge Articles
OpenClinica 3 User Documentation
OpenClinica 3 Technical Documentation
LMS FAQ's
Release Notes (OC4)
Release Notes (OC3)
Data Mart Guide

1.1.4 Reset Source Data Verification Status

Source Data Verification status can be reset from verified to unverified either manually by user with appropriate permissions, or automatically by the OpenClinica software under certain conditions. Once marked as unverified, the CRF can be verified again at any time. The Study Audit Log tracks any change in Source Data Verification status for a CRF.

Manually: To manually change the Source Data Verification status for any CRF, in the Source Data Verification page, click the SDV Complete icon in the SDV Status column:
- In the Source Data Verification By Event View, you click the icon for a CRF. After you click the icon, it becomes a checkbox, and the CRF is no longer reported as verfied.
- In the By Subject View, you click the icon for a Subject to reset the SDV Status for all CRFs for that Subject. After you click the icon, it becomes a checkbox, and all CRFs for that Subject are no longer reported as verfied.

Automatically: The OpenClinica software automatically resets the Source Data Verification status for a CRF from verified to unverified in these cases:
- When the CRF data changes
- When an Annotation Discrepancy Note is added to the CRF

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