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 (e.g. mortality, virology), 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:
General Information.
Background Information
Objectives
Study Design
Selection and withdrawal of subjects
Treatment of subjects
Assessment of efficacy
Assessment of safety
Statistics
Access to source documents
Quality control and assurance
Ethics
Data handling and record keeping
Financing and insurance
Publication policy
NIH provides many invaluable resources for protocol development, such as protocol templates to help investigators in writing and developing clinical research protocols that are in compliance with regulatory and other requirements. Some NIH institutes have a mandatory requirement for using their protocol template.
For an example of a protocol format that complies with ICH GCP requirements, please refer to this template: Protocol
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