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:

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

ADDITIONAL RESOURCES

Clinical Trials Resource Center (CTRC)
7000 Fannin Street, Suite 795
Houston, Texas 77030
phone 713-500-3622
fax 713-500-0334
clinicaltrials@uth.tmc.edu