Getting Started

Welcome to OpenClinica 4 (OC4).

This guide provides step-by-step instructions for building studies and forms, managing data, and supporting your study team and sites.

It also includes information about the following optional modules:

• Recruit – Participant recruitment and prescreening

• Participate – Participant engagement and electronic patient-reported outcomes (ePRO)

• Consent – 21 CFR Part 11–compliant electronic consent forms

• Insight – Reporting, visualization, and data warehousing

• Randomize – Clinical trial randomization and supply management

• Code – Standardized medical-terminology coding

OpenClinica is designed to be easy to learn and use, helping research teams quickly build studies, capture high-quality data, and collaborate effectively.
It is trusted in thousands of studies worldwide to capture, organize, and manage critical research data efficiently and securely.

We are committed to providing a reliable, intuitive, and high-quality experience that supports your success from study design through data analysis.

Next steps
See the following sections to learn how to log in and begin working in OpenClinica.