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.

TEMPLATES:  For an example of a protocol format that complies with ICH GCP requirements, please refer to this template:

According to ICH E6 Good Clinical Practice Guidelines, a clinical trial protocol should include the following information:

General Information

Background Information

Trial Objectives and Purpose: A detailed description of the objectives and the purpose of the trial.

Trial Design: The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design should include:

Selection and Withdrawal of Subjects

(a) When and how to withdraw subjects from the trial/investigational product treatment

(b) The type and timing of the data to be collected for withdrawn subjects

(c) Whether and how subjects are to be replaced

(d) The follow-up for subjects withdrawn from investigational product treatment/trial treatment.

Treatment of Subjects:

Assessment of Efficacy

Assessment of Safety

Statistics

Direct Access to Source Data/Documents The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspection(s), providing direct access to source data/documents.

Quality Control and Quality Assurance

Ethics: Description of ethical considerations relating to the trial.

Data Handling and Recordkeeping

Financing and Insurance: Financing and insurance if not addressed in a separate agreement.

Publication Policy Publication policy, if not addressed in a separate agreement.

Supplements (NOTE: Since the protocol and the clinical trial/study report are closely related, further relevant information can be found in the ICH Guidance for Structure and Content of Clinical Study Reports.)

ADDITIONAL RESOURCES

CLINICAL RESEARCH UNITS (CRU) | BERD | REDCap
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS | ANIMAL RESEARCH | ENVIRONMENTAL HEALTH & SAFETY | CORE LABORATORIES | SPONSORED PROJECTS TECHNOLOGY MANAGEMENT
OFFICE OF RESEARCH 

Center for Clinical and Translational Sciences

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