Clinical Study Protocol Writing for Medical Writers

3-Day Training Workshop

• Daily Duration: 8 hours
• Total Training Hours: 24 hours
• Onsite: Amman, Jordan

Target Audience

• Clinical research coordinators (CRC)
• Clinical research associates (CRA)
• Medical writers
• Research pharmacists
• Investigators involved in clinical trials
• Regulatory affairs professionals
• Clinical research staff at hospitals, universities, government, or CROs

Day 1: Foundations of Clinical Study Protocol Writing

• Focus: Understanding protocol structure and scientific rationale.
• Outcome: Participants learn how to write a clear scientific rationale and background section.

Day 2: Study Design, Statistics, and Protocol Methodology

• Focus: Writing the scientific core of the protocol.
• Outcome: Participants draft key protocol methodology sections.

Day 3 – Quality, Ethics, and Protocol Review

• Focus: Quality assurance, feasibility, and stakeholder collaboration.
• Outcome: Participants complete and review a mini clinical study protocol.

Prerequisite
Participants should have basic knowledge of clinical trials, clinical research concepts, and basic knowledge of clinical trial protocol writing.

Expert-led Training
Dr. Qusai Al-Share Associate Professor of Pharmacology with 17+ years of global clinical research leadership, leading Phase 1–3 trials and contributing to approved therapies.