Download - Clinical Study Protocol
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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