Protocol - Definition

A document that states the background, objective, rationale. Design, methodology (including the methods for dealing with AEs, withdrawan etc) and statistical considerations of the study. It also states the conditions under which the study shall be performed and managed.

Contd..
The contents and format of the Protocol should take into consideration the adopted SOPs, the regulatory requirements and the guiding principles of GCP. The term Protocol specified relates to the latest amended version of the document, read in conjunction with all its appendices & enclosures.

PROTOCOL WRITING
IT IS A TIME CONSUMING EXERCISE, BUT IF CORRECTLY DONE, A PROTOCOL IS AN EXTREMELY USEFUL DOCUMENT. WHY IS IT NEEDED? WHAT IS THE FEASIBILITY OF THE STUDY? IS REGULATORY REQUIREMENT NECESSARY FOR THE STUDY? WHAT QUESTIONS MUST THE STUDY ANSWER?

SKETCH I/E CRITERION EFFICACY/SAFETY PARAMETERS DEVELOPING TIME & EVENTS SCHEDULE MEDICINE PREPN & COLLECTING DATA FOR ADR INFORMED CONSENT& IEC REVIEW

REMOTE DATA ENTRY & INTRODUCTION PREPN PROTOCOL STANDARDIZATION PATIENT DROP OUTS ,IN REGULATORY & ETHICAL CONSIDERATIONS

Protocol Terminologies
1.

Protocol Amendment(s) Any change or formal clarifications appended to the Protocol . All Protocol Amendments should be agreed upon and signed by the persons who were the signatories to the Protocol.

2. Protocol Deviations(major/minor)
A major deviation from the study Protocol is regarded as a Protocol violation , whereas a minor departure is regarded as a Protocol deviation. Protocol deviators are defined as those patients who met the initial admission criteria & subsequently during the course of the study developed changes that meant that they no longer continued to meet the I/E criteria as laid down in the Protocol.

Contd.
This is termed as Protocol deviation. The major impact of deviation/violation decision is that patients who are regarded as protocol violators would not be included in any efficacy analysis whereas patients designated as protocol deviators would be included in such an analysis.

3. Protocol Review Committee

A Protocol review committee is an internal body within a pharmaceutical company which reviews all clinical trial protocols to ensure that they are in compliance with company standard operating procedures.

Contd.
The members of the committee are drawn from different specialities within the company (eg CR, Regulatory Requirements, medical, marketing , statistics, data handling & the Clinical supplies department)

Protocol Violation
An event occuring in a study which is not in compliance with the Protocol demands of the protocol & for which an amendment has not been granted. A common protocol voilation involves the recruitment of patients into the study with agesouside the range specified in the Protocol.

Contents of Protocol
Title

Page Background Information Trial Objective & Purpose Trial Design Selection & withdrawals of Subjects Treatment of Subjects

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Assessment

of Safety Assessment of Efficacy Statistics Direct Access to Source Data Documents Quality Control & Quality Assurance Procedures Ethics

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Data

handling & Record Keeping Financing & Insurance Publication Policy Supplements- Clinical Study Report

Thanks