Quality research starts with people who are trained and ready for the work in front of them.
Univo Consulting provides training for research teams and the offices that support them. Our TransCelerate-recognized Good Clinical Practice (GCP) course is aligned with ICH E6(R3). It prepares sponsors, contract research organizations, sites, and institutions to protect participants, meet study objectives, and comply with applicable regulations.
We also design customized training for IRB offices, Institutional Animal Care and Use Committees (IACUCs), Institutional Biosafety Committees (IBCs), research administration offices, and research teams. Topics range from onboarding new IRB staff and accreditation preparation to informed consent, data safety monitoring, FDA inspection readiness, and more. Each program is tailored to your needs and the work your team does every day.
GCP Training
TransCelerate-recognized. Built for today’s clinical trials.
High-quality clinical research starts with a research team that is trained and qualified to carry out study requirements. Our GCP training goes beyond the minimum, focusing on how to protect participants, meet study objectives, and follow ICH E6(R3) and applicable regulations. The training is designed around how research actually happens at the site. It covers ICH E6(R3) and Annex 2, including considerations for trials with decentralized elements and digital health tools.
What sets it apart
- Real-world scenarios. Relatable examples that make complex requirements practical.
- Hands-on activities. Exercises such as spotting errors in source documents and managing delegation of authority logs.
- Focused on common site challenges. Good documentation practices, essential records, and other areas where quality issues often arise.
- Designed for retention and application. Built so teams can apply what they learn in daily trial conduct.
What the training covers
Thirteen modules cover a clinical trial from its ethical foundations through close-out. What your team will learn:
- Foundations of GCP. Research ethics, guidelines and regulations, and the structure, key updates, and principles of ICH E6(R3).
- Roles and study conduct. Sponsor, CRO, IRB/IEC, and investigator responsibilities, protocol compliance, and the informed consent process.
- Data and documentation. Data governance, essential records, source documentation, case report forms, and good documentation practices.
- Investigational product and safety. Investigational product from receipt to disposal, adverse event and safety reporting, and ongoing risk assessment.
- Oversight and close-out. Monitoring, audits, and regulatory inspections, through trial closure and post-trial responsibilities.
- Modern trial designs. Annex 2 topics including technology and digital health tools, participant protection and communication, roles and responsibilities, and risk-based quality management.
Flexible Training Options
- Organization-wide. 1- or 3-year agreements, delivered as a SCORM package for your LMS or hosted on Univo’s platform.
- Individual access. Single-user training through Univo’s platform, $99 per person.
Contact Justin Osborne, Vice President, Consulting Services, at [email protected] or 513-885-5006 for organizational pricing.
Customized Training
We tailor training to your staff’s roles, experience, and priorities, building in your institution’s own policies and procedures where it helps. We deliver it in the format your team prefers.
Training topics include:
- IRB training. For IRB members, chairs, investigators, and study teams, from review criteria to preparing submissions.
- New IRB staff training. Onboarding on regulatory foundations, submission review, your office’s SOPs, and its workflows.
- Accreditation preparation. Preparing leadership, staff, and committee members for AAHRPP or AAALAC accreditation.
- IACUC training. Protocol review, program reviews, and facility inspections.
- Biosafety training. Protocol review for research involving known or potential biohazards, and NIH biosafety requirements
- Data Safety Monitoring training. Monitoring plans, safety reporting, and DSMB roles, responsibilities, and charters.
- Research administration training. Pre-award and post-award processes, grants and contracts, and research billing compliance.
- FDA inspection readiness training. What IRB programs and study teams can expect when FDA inspectors arrive.
- Informed consent and participant protections. Consent processes and proportionate safeguards for participants.
- AI in research. Reviewing and overseeing AI-enabled tools used in research.
Don’t see the topic you need? Tell us what your team is working through, and we’ll build training around it.
