Pathways to PI

Competency-Based Training for Subinvestigators and New PI

By: Essam Abdelhakim

Narrated by: Virtual Voice

Pathways to PI is a comprehensive, competency-based training guide designed to support subinvestigators And newly appointed principal investigators (PIs) as they develop the skills and confidence to lead clinical research sites.

The book is built around 38 structured assessments, each carefully designed to evaluate knowledge and practical skills essential for safe, ethical, and high-quality trial conduct. These assessments cover the full spectrum of investigator responsibilities, from informed consent and safety reporting to eligibility review, oversight, delegation, and leadership.

Each chapter combines practical training modules with hands-on exercises—including quizzes, role-play scenarios, and case-based drills—ensuring that trainees are not only taught but also formally assessed and signed off as competent.

🔹 Key Features:

• 38 Competency Assessments aligned with ICH-GCP and regulatory requirements.

• Quizzes that test both knowledge and application across ethics, safety, data integrity, and protocol compliance.

• Templates and Forms (training logs, delegation logs, SAE trackers, unblinding request forms, consent checklists, eligibility worksheets, etc.) ready to use at the site level.

• Role-play and simulation exercises to prepare investigators and nurses for real-world scenarios under audit-ready conditions.

• Documentation standards to create a complete, auditable training file for each staff member.

By the end of this book, readers will have a clear, structured pathway from subinvestigator to principal investigator—with the tools, frameworks, and documented competencies needed to step confidently into site leadership.