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.
Protocol Template for Observational Studies: A type of study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (for example, no treatment is given). Examples of observational studies include retrospective chart review studies, study involving prospective data collection, studies involving analysis of biospecimen that have already been collected, registry studies etc.
Protocol Template for Clinical Trials: Clinical trial is research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.) Decision Tool: Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial? You do not have to use these templates - just make sure that the protocol contains all the necessary information (see page 39 - Section 6. Clinical Trial Protocols - ICH E6(R2) Good Clinical Practice Guidelines)
If you have suggestions to improve these templates, please contact [email protected]. We welcome your questions, comments and feedback on these templates.
ADDITIONAL RESOURCES
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS | ANIMAL RESEARCH | ENVIRONMENTAL HEALTH & SAFETY | CLINICAL RESEARC UNIT | CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCE | BIOSTATISTICS, EPIDEMIOLOGY AND RESEARCH DESIGN | CORE LABORATORIES | SPONSORED PROJECTS | TECHNOLOGY MANAGEMENT
OFFICE OF RESEARCH
Clinical Trials Resource Center (CTRC)
7000 Fannin Street, Suite 795
Houston, Texas 77030
phone 713-500-3622
fax 713-500-0334
[email protected]
