Protocol development and complexity depends greatly upon the type of clinical study being conducted. For instance, interventional, multi-site, greater than minimal risk studies require more protocol content than minimal risk and single site.
When developing a successful study design and writing a protocol, the researcher must address various essential components- including the types of data being collected, (e.g. safety, laboratory), data handling and record keeping, outcome measures, how monitoring and reporting will occur, and data analysis.
A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. According to the ICH Good Clinical Practice guidelines, a protocol should include the following topics:
TEMPLATES: For an example of a protocol format that complies with ICH GCP requirements, please refer to this template:
Other examples of protocol templates: