Clinical Trials Phase I

Clinical Trials Phase I Training: From First-in-Human Design to Safe Dose Escalation

Phase I is where a clinical program is de-risked or derailed. A single dose-setting error can halt a compound indefinitely and cost a sponsor years of development. This certified online learning path for Phase 1 clinical trials, developed under the expert guidance of Dr. Patricia Kay, equips clinical research professionals with the scientific, regulatory, and operational knowledge to design and execute safe, compliant first-in-human studies that meet ICH-GCP E6(R3) and FDA expectations.

Course Breakdown:

• First in Human Safety Assessment (FIHSA) Dossier: Learn how preclinical safety data is synthesized into the FIHSA dossier to justify the starting dose and support the regulatory decision to proceed to humans.
• ICH-GCP: Introduction to Good Clinical Practice: Build the GCP foundation required for every clinical research role, covering trial conduct standards, investigator responsibilities, and data integrity.
• GCP Refresher 2026: ICH-GCP E6(R3) Revision: Stay current with the most important GCP update in a decade and understand how E6(R3) reshapes Phase I trial operations.
• Pharmacokinetics and Pharmacodynamics: Master the PK/PD concepts that drive dose selection, exposure-response modeling, and safety monitoring in first-in-human studies.
• Selection of Trial Sites: Apply the criteria and processes for identifying, evaluating, and qualifying Phase I units that meet sponsor and regulatory requirements.
• 21 CFR Part 50: Informed Consent of Human Subjects: Understand the ethical and regulatory requirements governing informed consent in early-phase clinical trials.
• GMP for Clinical Trials Manufacture and Supply: Ensure investigational medicinal products are manufactured, labeled, and supplied in full compliance with GMP for Phase I studies.

Why Choose This Learning Path?

• Expert-Led Curriculum: Developed by Dr. Patricia Kay, a senior research management professional with 20+ years across clinical development, health program management, and regulatory strategy in early-phase research.
• End-to-End Coverage: From FIHSA preparation and PK/PD fundamentals through GCP, site selection, and IMP supply, every operational pillar of Phase I in one path.
• Flexible Learning: Fully self-paced and online. Study around your trial commitments and revisit content as ICH and FDA guidance evolves.
• Recognized Certification: Earn a CPD/CEU-accredited, 21 CFR Part 11-compliant certificate validating your Phase I competency to sponsors, CROs, and regulators.

What You’ll Be Able to Do

• Apply ICH-GCP E6(R3) requirements to first-in-human study design and conduct.
• Interpret PK/PD data to inform dose escalation decisions.
• Qualify Phase I sites and manage IMP supply under GMP.
• Lead informed consent and ethics processes in early-phase settings.

Who Should Enroll?

Whether you are a clinical research associate, study manager, clinical pharmacologist, or regulatory professional preparing to work on first-in-human studies, this path was designed for you. It is equally valuable for pharmaceutical, biotech, and CRO teams building Phase I capabilities or onboarding clinical staff into early-phase programs.

Lead the Most Critical Phase of Clinical Development

GxP Training delivers certified, employer-recognized training to life sciences professionals worldwide. In an era where a single Phase I failure can delay an entire program by years, first-in-human competency isn’t optional. It is your career foundation. Enroll today and build the skills first-in-human trials demand.