Clinical Trial Protocol and IB

Question 1

According to ICH GCP, what general information should be included in the clinical trial protocol?

Answer 1

• Protocol title, identifying number and date
• Name and address of the sponsor and monitor
• Name and title of person authorized to sign the protocol
• Investigator’s name and title
• Name, title, address and phone for qualified physician/dentist and medical expert
• Name and address of clinical laboratories being used

Question 2

According to ICH GCP, what type of background information should be included int he clinical trial protocol?

Answer 2

• Name and description of investigational product
• Data from nonclnical studies
• Known risks and benefits
• Justification and description for route of administration, dosage, dosage regimen and treatment periods
• Statement that the trial will be conducted in compliance with the protocol, GCP, and regs
• Population to be studies
• Any relevant references to literature and data

Question 3

According to ICH GCP, what types of information should be included in the clinical trial protocol?

Answer 3

• General trial information and background information
• Trial objectives and purpose
• Trial design
• Selection and withdrawal of subjects
• Treatment of subjects
• Safety and Efficacy info
• Statistical methods
• Access to source data/documents and data handling
• QA/QC information
• Ethics
• Financing and Insurance information
• Publication policy

Question 4

According to ICH GCP, what info should be included in the trial design section of the trial protocol?

Answer 4

• Statement of primary and secondary endpoints
• A description of the type of design to be conducted (placebo-controlled, parallel, etc.) with a diagram
• Measures used to minimize bias (Randomization or blinding)
• Description of treatments, dosage, etc. and what the investigational product looks like
• Description of stopping rules or discontinuation criteria
• Accountability procedures
• Randomization codes and procedures
• Data to be included in CRFs

Question 5

What types of subject withdrawal information are typically included in the trial protocol?

Answer 5

• When and how to withdraw subjects
• Type and timing of the data collected from withdrawn subjects
• Whether and how subjects are to be replaced
• Subject followup following withdrawal

Question 6

What types of information regarding statistical methods are typically included in the trial protocol?

Answer 6

• Timing of any planned interim analyses
• Number of subjects to be enrolled (at each site if multicenter) and justification for that number
• Level of significance to be used
• Criteria for trial termination
• Procedure for accounting for missing, unused and spurious data
• Procedures for an deviations from original statistical plan

Question 7

What is the Investigator’s Brochure (IB) and what is its purpose?

Answer 7

The IB is a collection of clinical and nonclincal data on the investigational product relevant to the study. Its purpose is to provide investigators and other in the trial information necessary to comply with the protocol and understand the purpose for the trial.

Question 8

According to ICH GCP, how often should the IB be reviewed?

Answer 8

At least annually and revised as necessary with compliance to sponsor’s written procedures.

Question 9

Who is responsible for keeping an up-to-date IB?

Answer 9

The sponsor.

Question 10

What sections should make up the IB?

Answer 10

• Table of Contents
• Summary
• Introduction
• Physical, chemical and pharmaceutical properties / formulation
• Nonclinical studies
• Clinical data
• Summary of data and Investigator guidance