Easy Guide to Clinical Studies (Easy GCS) Beta

The Easy Guide to Clinical Studies (Easy GCS) is a Swiss web‑based resource that supports the full life cycle of clinical studies, from early concept and feasibility through approval, conduct and completion. It focuses on practical study management questions that arise when planning and running clinical research in line with ethics and regulatory requirements. The toolbox is developed, written and reviewed by clinical research experts from Swiss Clinical Trial Organisation platforms, the Clinical Trial Unit (CTU) network and the Swiss Biobanking Platform, with contributions from other Swiss groups. It can help sponsor‑investigators and academic study teams understand what is expected at each phase and within each subject area, reducing the risk of overlooking critical steps such as ethics submissions, safety reporting or quality management activities. It can be useful when planning collaborative projects involving Swiss and European partners.

The toolbox is structured as a grid:
Horizontally into six study phases: Basic, Concept, Development, Set‑Up, Conduct and Completion.
Vertically into eleven study subjects: protocol, management, ethics and laws, documents, safety, data management, statistical methodology, quality and risk, monitoring, drug or device and biobanking.
Each grid cell combines one phase and one subject and lists keywords that reflect common clinical research tasks or questions at that point in the study.
Selecting a keyword takes users to topic pages that provide high‑level explanations, outline key operational steps and signpost relevant support or expertise, making them suitable as quick reference material and teaching aids.

Scope and content
The toolbox offers a single entry point to background information, regulatory context and operational guidance needed to design and run compliant clinical studies in Switzerland and beyond. It provides focused content on ethics and regulatory requirements, study management and quality, safety reporting, data management and statistics, monitoring and risk management, and integration of biobanking into clinical studies. Because many topics are framed in terms of good clinical practice and internationally relevant processes, the resource is also useful when Swiss study teams collaborate with partners in other European countries or when European groups work with Swiss sites.

It supports step‑by‑step planning and conduct of academic and other non‑commercial studies, from early concept through study closure and can be used as a structured reference during protocol development, preparation of submissions, study set‑up, routine conduct, safety reporting and close‑out activities.