This course is designated to assist the ophthalmic health professional in making the transition from routine patient caregiver into the role of a Clinical Research Coordinator (CRC) within the private ophthalmology practice. Topics addressed will include ICH-GCP requirements, IRB and regulatory documentation, informed consent, audits, and tips and pearls for maintaining site files and data submission.

Learning Objectives:

• Explain the fundamentals of ICH-GCP.
• Describe the regulatory documents necessary prior to beginning a clinical trial.
• Discuss informed consent in relation to clinical trial procedures.

JCAP3030

Provided by JCAHPO

Diana M. Hatsis, COT, RN, BSN

Level: Advanced