CLINICAL STUDY

PROTOCOL

What is a Clinical Study Protocol?Clinical Study Protocol:

Is defined in the ICH E6 Good Clinical Practice as the document that describes “the objective(s), design, methodology, statistical considerations, and organization of a trial…[and] usually also gives the background and rationale for the trial”

Explains the purpose of the study as well as how to carry it out

Includes some specific things viz., the reason for the study, number of participants, inclusion and exclusion criteria, details of the intervention or therapy the participants will receive (such as frequency and dosage), what data will be gathered, study endpoints, and statistical methods

Sections of a Protocol

General information

Background information

Trial objectives

and purpose

Trial design

Selection and

withdrawal of subjects

Treatment of subjects

Assessment of efficacy

Assessment of safety

Statistics

Direct Access to

Source Data/

Documents

Quality control and

quality assurance

Ethics

Data handling

and record keeping

Financing and

insurancePublication

policySupplement

s

According to the ICH Good Clinical Practice Guidelines, a protocol should include the following sections:

Protocol Synopsis It is a brief outline of the study which enables the investigators, study

coordinators, IRB reviewers and regulatory personnel to acquaint themselves with the study

It is often used by the investigators while applying for grants or seeking resources/other support to undertake the study

Key Elements of a Good Synopsis

Design of the study

Clear research question

Study population

and interventio

n

Objectives and end-points of the study

Methodology of the

study

Statistical methods to

be employed

Clinical Trial in Compliance With the Protocol As per ICH-E6 guidelines, the investigator/institution should conduct the trial

in compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies), and which was given approval/favorable opinion by the IRB/IEC

The investigator should generally not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment

The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard(s) to trial subjects without prior IRB/IEC approval/favourable opinion

Resources for Designing a Protocol for a Study:Resources for Designing a Protocol are:

ICH General Considerations, together with the Section 6 of ICH-E6 guidelines on ‘Good Clinical Practice’, form an internationally accepted basis for preparing a study protocol

Protocols for a product studied as an Investigational New Drug (IND) must follow the format outlined in the IND Content and Format, item 6 "Protocols" section, of the FDA Code of Federal Regulation

NIH Protocol Guidelines outline what is required for a protocol funded by the NIH

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