Clinical Trial Protocol and Amendments - ICH

Question 1

General Information

Answer 1

Protocol title, name and address of sponsor and monitor, name and title of investigator’s responsible for conductnig the trial

Question 2

Background Information

Answer 2

Name and description of background projects
Summary of findings from non-clinical studies
statement trial will be conducted according to GCP

Question 3

Trial Objectives and Purpose

Answer 3

A detailed description of objectives and the prupose of a trial

Question 4

Trial Design

Answer 4

primary and seconary endpoints
description of any randomization and blinding

Question 5

Selection and withdrawal of Subjects

Answer 5

subject inclusion and exclusion criteria
subject withdrawal criteria

Question 6

Treatment of Subjects

Answer 6

The treatments to be administered, the dose, dosing schedule, route and mode of administration

Question 7

Assessment of Efficacy

Answer 7

Specification of the efficacy parameters
methods of timing for assessing, recording, and analyzing efficacy parameters

Question 8

Assessment of Safety

Answer 8

Specifying safety parameters, tis methods, procedures, etc

Question 9

Statistics

Answer 9

Desription of statistical methods to be employed
Number of subjects planned to be enrolled

Question 10

Direct Access to Source Data

Question 11

Quality Control and Quality Assurance

Question 12

Ethics

Question 13

Data Handling

Question 14

Financing and Insurance

Question 15

Pubication policy

Question 16

Supplements