Clinical Trial Protocols

A clinical trial protocol is an essential element in GCP guidelines and compliance. At its most basic, a clinical trial protocol is a study plan on which all clinical trials are based.

A protocol or plan has to be properly designed in order to protect the welfare and health of trial subjects as well as properly answer clinical research questions.

A protocol describes the following aspects of clinical trials:

  • Types of people who may participate in the trial;
  • The schedule of tests, procedures, medications, and dosages; and
  • The length of the study
Contents of Clinical Trial Protocols

The clinical trial protocol should include the following content with respect to clinical trials:

  • Identifying information
  • Background information regarding
    • Investigational product
    • Previous studies
  • Trial Objectives, Purpose and Design
  • Selection of Subjects
  • Assessment of Efficacy
  • Assessment of Safety
  • Statistics
  • Access to Trial Data/Documents
  • Ethical Considerations
  • Insurance and Financing
  • Publication Policy
Clinical Trial Protocol Amendments

The purpose of amendments to clinical trial protocols is to update the protocol for changes that significantly affect subject safety, scope of research or a clarification.

Complying with Clinical Trial Protocol

GCP guidelines state that the investigator should conduct the trial in compliance with the protocol agreed to by the sponsor. The investigator and the sponsor should sign the protocol, or an alternative contract, to confirm agreement.

ComplianceOnline training on Good Clinical Practices (GCP)

Clinical Trials and Good Clinical Practice
This Clinical Trials and GCP session describes the principles of Good Clinical Practice including drug development process and Specifics of GCP and quality as related to central laboratory work.

The Importance of ICH Guidelines and its Role in Achieving Good Clinical Practice
This presentation reviews the key concepts of GCP and correlates them to the ICH guidelines.

How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits
This Clinical Trial training provides a detailed review of the FDA regulations for Clinical Trials Process.