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:
- Background Information
- Justification for number of subjects
- Selection, inclusion & exclusion criteria
- Withdrawal of subjects
- Study Design
- Treatment of subjects
- Assessment of efficacy
- Assessment of safety
- Access to source documents
- Confidentiality, record maintenance & retention
TEMPLATES: For an example of a protocol format that complies with ICH GCP requirements, please refer to this template:
Other examples of protocol templates:
- DMID- Minimal Risk Template
- DMID- Greater Than Minimal Risk Template
- DMID- Interventional Template
- NIAID Clinical Research Toolkit- Clinical Trials Protocol Templates
- NCI- Protocol Development Guidelines
last modified October, 2013
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