Open Clinica EDC FAQs
OpenClinica EDC
Frequently Asked Questions — the clinical data capture system behind Study Hub
Overview
What is OpenClinica EDC?
An EDC (Electronic Data Capture) system is the platform your study team uses to collect, manage, and store clinical trial data — purpose-built for research, with the structured data collection, audit trails, and regulatory compliance that general-purpose tools like spreadsheets or survey platforms simply can't provide. It's where your study data lives, where your team collects forms, tracks participants, and manages the study from start to finish. Beyond core data capture, it extends to eConsent, eCOA, and automated medical coding, so your study can run on one connected platform instead of stitching tools together.
The OpenClinica EDC is built for research teams — including academic medical centers, research sites, CROs, and mid-market research organizations — who need a compliant, structured platform for running regulated studies.
Compliance & Data Integrity
What regulatory standards does OpenClinica EDC meet?
OpenClinica EDC is built to meet the compliance standards that grant funders, IRBs, and sponsors require, including:
- 21 CFR Part 11 — the FDA regulation governing electronic records and electronic signatures
- ICH E6(R3) — the international Good Clinical Practice (GCP) guideline
- HIPAA — federal privacy protections for health information
- GDPR — European data protection regulation
These controls are built in — not something your team has to configure or validate from scratch.
What audit trail capabilities does OpenClinica EDC provide?
OpenClinica EDC maintains a comprehensive, regulation-aligned audit trail that tracks data entry, edits, key user actions, and system events. This audit trail is available on the platform around the clock, so your team always has the documentation auditors require, right when they need it.
Where can I access compliance and validation documentation?
Product validation documentation — including testing tied to specific regulatory requirements — is available on demand through the OpenClinica trust center (trust.OpenClinica.com). This package gives you the technical evidence that sponsors and CROs need to demonstrate their tools are validated and compliant — work that, with general-purpose tools, you'd otherwise have to generate or reconstruct yourself.
Does OpenClinica EDC support electronic signatures?
Yes. OpenClinica EDC supports electronic signatures in compliance with 21 CFR Part 11, which governs the use of electronic records and signatures in FDA-regulated research.
How does OpenClinica EDC handle data security and access control?
OpenClinica EDC allows you to assign each user a role that determines their permissions and form access level. Access is restricted by role, and user activity is logged to the audit trail — supporting GCP requirements for data integrity and accountability.
Features & Functionality
Study Setup & Configuration
Does my team need to build out the EDC study themselves?
No. You won't be starting from scratch. Submit your protocol and study specifications, and the OpenClinica team builds an initial version of your study in OpenClinica EDC — forms, events, edit checks, notifications, permissions, and participant structure — based on what you provide. From there, we work with you to refine and finalize the build together, so the heavy lifting is done, but you stay involved in getting it study-ready.
What is included with OpenClinica EDC as part of Study Hub?
OpenClinica EDC gives you everything needed to run a single study end-to-end:
- Standard form templates for clean, structured data collection
- Study, site, and form-level access configuration
- Role-based permissions for your team
- 24/7 self-service compliance documentation
- Email and text notifications
- Participant tracking and management
- Data cleaning and review tools
- Study data extracts available on-demand
- Multi-language support
- Ability to enhance forms with multimedia such as images and video
- À la carte add-on’s including eCOA, eConsent, and Code
What role-based access controls are available?
OpenClinica EDC includes configurable role-based permissions out of the box. Each user is assigned a role — such as Data Manager, Investigator, Coordinator, Monitor, or Viewer — that determines their permissions and form access levels.
How are participants tracked in the EDC?
Each participant has a dedicated record in OpenClinica EDC that provides a complete overview of that participant's data, form and event statuses in one place. Email and text notifications can be configured to alert your team when key actions occur, such as event completion, or important queries.
Data Collection
Can participants complete forms directly in the EDC?
Participants can be involved directly through two add-ons: eConsent and eCOA. eConsent is a digital process for obtaining informed consent remotely or in clinic, equipped with 21 CFR Part 11-compliant signatures. eCOA allows participants to directly enter patient-reported outcomes electronically, such as study questionnaires or diary entries. Both are accessible on tablets, smartphones, or computers.
What is Code, and how does it help with data management?
Code is OpenClinica's medical coding add-on with auto-coding included. It currently supports MedDRA coding — configurable to your study's specific coding needs, such as adverse events and medical history with WHODrug medication coding coming soon.
Add-Ons
What add-ons are available for OpenClinica EDC?
The following are available à la carte:
- eCOA — Electronic Clinical Outcome Assessment for participant-reported data
- eConsent — Electronic informed consent capture and management
- Medical Coding — Automated medical coding of adverse events and medical history using the MedDRA dictionary (WHODrug medication coding coming soon)
- & more just ask!
Integration with Recruit
How does data get from Recruit into OpenClinica EDC?
When a lead is ready to enroll, their information transfers from Recruit directly into OpenClinica EDC with a single click — no copy-paste, no manual re-entry, no transcription errors. OpenClinica EDC automatically creates the participant record and populates it with the lead's data.
What data transfers from Recruit to the EDC at enrollment?
Lead data collected during screening in Recruit — including contact information and screening form responses — transfers into the EDC participant record. This eliminates the need for coordinators to re-enter information and reduces the risk of transcription errors.
Is the transfer automatic, or does a coordinator initiate it?
The transfer is a deliberate, coordinator-initiated action at the point of enrollment — not an automatic background sync. This ensures that only leads your team has reviewed and approved are moved into the clinical data environment, maintaining proper data governance between the two systems.
Do Recruit and OpenClinica EDC share logins?
Not today — each platform has its own login. We're planning to integrate the login experience in 2027, so users will be able to move between both systems with a single sign-on.
Support & Onboarding
What support is available for OpenClinica EDC?
Study Hub clients have access to a dedicated Customer Success Associate (CSA) — not just a community forum or ticket queue. When your team has a question or hits a roadblock, you have a real contact to reach out to. You'll also have access to an AI chat assistant trained on OpenClinica's full documentation set, available anytime you need a quick answer. In addition to your designated CSA and AI assistant, your team will also be able to submit tickets directly to the OpenClinica Support team, with support provided 24/5.
How does onboarding work for OpenClinica EDC?
You submit your protocol and study specifications, and the OpenClinica team builds an initial version of your study — forms, events, edit checks, notifications, permissions, and participant structure — based on those requirements. From there, we work with you to refine and finalize the build together. As you get started, your study team also receives training directly inside the product, so your team learns the system in the context of your actual study.
Where can I find documentation and help resources?
Your support portal is the best place to start — search the knowledge base or ask the AI chat assistant, trained on OpenClinica's full documentation set, for a quick answer anytime. If you need more help, your dedicated CSA is your next point of contact, reachable directly through the Foundation platform, Monday–Friday, 9–5 ET. Compliance and validation documentation is also available 24/7 through the OpenClinica trust center.
Have additional questions? Contact your Customer Success Associate (CSA) or visit OpenClinica.com.