EDCTP Protocol development tool

A Protocol Development Toolkit helps investigators by providing a structured framework, practical resources, and standardised templates to guide the design and writing of a high-quality clinical trial protocol. The Protocol Development Toolkit is a central part of the EDCTP Knowledge Hub, developed to support investigator‑initiated teams in low‑resource settings to design high‑quality clinical research protocols. The Toolkit provides investigators with a practical, end-to-end framework for designing, writing, reviewing, and implementing high-quality clinical research protocols by combining step-by-step guidance, collaborative review, SPIRIT-based protocol development tools, implementation planning, and curated methodological resources.