Clinical Trials Resource Center

Protocol Development

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:

General Information:

  • Background Information
  • Objectives

 

Population:

  • Justification for number of subjects
  • Selection, inclusion & exclusion criteria
  • Withdrawal of subjects

 

Methodology:

  • Study Design
  • Treatment of subjects
  • Assessment of efficacy
  • Assessment of safety
  • Access to source documents
  • Confidentiality, record maintenance & retention

 

Statistical Analysis

References, Publications

 

TEMPLATES:  For an example of a protocol format that complies with ICH GCP requirements, please refer to this template:
Protocol Template (simple)
Protocol Template (complex)

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