Clinical trial protocols

Research protocols

The protocol is the document that describes the background, rationale, objectives, design, methods, statistical analysis, ethical considerations, and organization of a research study.

Research protocols can be very different. For instance, there will be many differences between an oncology phase II trial with a novel drug and an observational study in nutrition. However, all protocols share a common structure and common elements, such as the background, inclusion and exclusion criteria, study endpoints, and data analysis.

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Translation of a protocol

On average, clinical trial protocols have approximately 25,000 words (some 80 to 100 pages). The translation of a clinical trial protocol takes approximately 10 to 15 business days.

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Legal framework

In Spain, clinical trial protocols are translated into Spanish for submission to the Regulatory Authorities and the Research Ethics Committees.

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