RESEARCH PROTOCOL (Good Clinical Practices) by aks.pptx

THE RESEARCH PROTOCOL
Dr. Savitha A K
Junior Resident-1st
Year
Department of Pharmacology and Therapeutics
King George’s Medical University, Lucknow

Contents:
Introduction
Contents of the Research Protocol
What is a Protocol Amendment?
What is a Protocol Violation?
Summary of Key Points

Introduction
• What is Research Protocol?
Provides a plan for the essential aspects of the
proposed research.
It must be approved by IRB before the
research can begin.
Any changes to the protocol - must also be
approved by the IRB.

• Why is the research protocol so important?
It is one of the main documents that must be approved by the designated IRB.
The Good Clinical Practice (GCP) guidelines of the International Council for
Harmonization require a research protocol for any study that involves human
participants.
• Research that is not conducted in a standardized manner is unethical because it
may put research participants at risk while yielding invalid data.

 Standardization is critical
 Several documents are key to ensuring that a research study is conducted in a
standardized manner.
Investigator's Brochure
Operations Manual
Standard Operating Procedures
Other Study Documents

Contents of the Research Protocol
• Should provide a clear and complete description of the study (but not overly
detailed).
• The research protocol must clearly and precisely describe the following aspects
of the research study:
WHY?
WHAT?
WHERE?
WHO?
WHEN?

General Information
• Protocol: Title, Identifying number, Version number, and date.
• Investigators: Names and titles of the investigators responsible for conducting
the study
• Trial sites: Address and telephone number of the trial sites.
• Qualified physician :Name, title, address, and telephone number of the qualified
physician who is responsible for all study–related medical decisions.

• Sponsors :Name and address of the sponsor and monitor (if other than the
sponsor).
• Institutions :Names, addresses and telephone numbers of all institutions involved
in the study (including clinical laboratories and other medical or technical
departments).

Background information
• Description:
Issue the study is addressing
Its public health significance
• Findings: Significant Clinical or nonclinical studies related to the proposed study.
• Summary: Known potential risks and benefits to human participants
• A statement that the trial will be conducted in compliance with the protocol,
GCP, and the applicable regulatory requirement(s)

• Description of the study population.
• References to relevant literature and data
• If the study involves the use of an investigational product or therapy:
• Name and description
• Description of and justification for the route of administration, dosage,
dosage regimen, and treatment period(s).

Study Objectives
A detailed description of the
Major (primary) objectives
Minor (secondary and exploratory) objectives
The purpose of the trial.

Study Design
• The scientific integrity and the credibility of the data
- largely depend on the study design.
Primary and secondary endpoints to be measured
and how they will be measured.
Study type with a schematic diagram
Measures that will be taken to avoid or minimize
bias (e.g. randomization, blinding)

Expected duration: Participant participation, sequence and duration of all study
periods, including follow–up.
Stopping rules: “Discontinuation criteria" for individual participants, parts of the
study, and the entire study.
Accountability procedures: for the investigational product, including the placebo
and comparator.
Coding: Maintenance of study treatment randomization codes and procedures
for breaking codes.
Identification of any data to be recorded directly on the CRFs and considered to
be source data.

Selection and Withdrawal of Study Participants
• Criteria: Inclusion and exclusion of participants.
• Procedures: Withdrawal of participants (participant or investigator-initiated):
When and how to withdraw participants from the study/investigational
product treatment.
Type and timing of data to be collected
How participants are to be replaced?
Follow–up for participants withdrawn from trial treatment.

Treatment of Participants
1)Pharmacological treatment:
• Names of all products to be administered.
• Doses.
• Dosing schedules.
• Method(s) of administration (i.e., oral, intramuscular).
• Other medications or treatments permitted (including rescue medication)
and not permitted before and/or during the study.

2) Other interventions: (i.e., chiropractic, physical therapy, social therapy,
behavioral therapy, counseling)
• Name of intervention (i.e., Motivational Interviewing, Cognitive Behavioral
Therapy).
• Frequency of sessions.
• Duration of each session.
• Method of each intervention
• Treatment adherence.

• For All interventions:
Period(s) of intervention, including follow–up periods for participants in each
group.
Procedures for monitoring participant compliance.
Identification of who will administer an intervention.

Assessment of Efficacy & Safety
• Efficacy: The methods that will be used to determine the success of the
treatment, including:
 Criteria for determining the treatment’s effectiveness.
 Methods and timing for assessing, recording, and analyzing the effectiveness
criteria.

• Safety : How the study will be monitored and how adverse events will be dealt
with.
 Specification of safety criteria
 Methods and timing
 Procedures for obtaining reports of adverse events
 Type and duration of follow–up

Statistics
The strategy for analyzing the data collected during the study, including:
• Statistical methods to be employed, including the timing of any planned interim
analyses.
• Total number of participants to be enrolled.
• Reason for the choice of sample size, including reflections on (or calculations of)
the power of the study and clinical justification.
• Level of significance to be used.
• Criteria for termination of the study.

• Procedure for accounting: for missing, unused, and false data.
• Procedures for reporting deviations from the statistical plan.
• Selection of participants to be included in analyses.

• Describing the set standards and controls to confirm that the execution of each
step follows the agreed–upon plan
• Usually submitted as a separate document.
• Measures taken to protect human participants and maintain confidentiality of
study data.
Quality Control & Assurance
Ethics

Data Management
A detailed data management plan describing the way study data will be :
Gathered
Documented
Submitted
Verified
Archived
• Usually submitted as a separate document.

• Procedures that will ensure data integrity
Data system design and development.
Data collection methods and activities.
Methods of data entry and editing.
Procedures for data monitoring (including query resolution), reporting, and
transfer.
Data recipients and procedures for data dissemination.
Data Management

Direct access to source data or Documents
• The sponsor should ensure that study investigators or institutions will permit
study–related monitoring, audits, IRB review, and regulatory inspections by
providing direct access to source data or documents.
Financing & Insurance
• How the study will be financed and insured.
• These issues are addressed in a separate agreement - need not be included in
the protocol.

Publication Policy
• Policies and procedures relating to publication of findings from the study.
• In some research networks - policies and guidelines are established for
researchers for the publications planning process.
• Researchers should be familiar with and adhere to institutional and sponsor
policies and requirements for publications.
• In accordance with the Food and Drug Administration Amendments Act  trial
results will also be published on a public website, ClinicalTrials.gov.

What is a Protocol Amendment?
• A Written description of a change to some aspect(s) of the study.
• Protocol amendments must be submitted in writing to the designated IRB.
• Must be approved by the IRB before they can be implemented.
• FDA as well as to the IRB – if study involves products approved by U.S FDA.
• Study participants must be informed of protocol amendments.
• Informed Consent Form may be revised - participants will need to complete and
sign a new Informed Consent Form.

• Exceptions:
 When necessary to eliminate immediate hazards to the participants
 When the change(s) involves only logistical or administrative aspects of the
trial (e.g., Change of monitor(s), telephone number(s)).

What is a Protocol Violation?
• A protocol violation occurs whenever a study staff person performs any action
that does not adhere to the research protocol
• A protocol violation may be:
An omission
(i.e., failure to do something required in the protocol)
An addition
(i.e., any action that is not required in the protocol).
A change in any procedure described in the protocol.

• Protocol violations may occur due to human error.
• Every attempt should be made to keep them at a minimum.
• Each violation and the action taken to correct the situation that led to the
violation must be documented and submitted to the IRB.
• Repeated protocol violations may indicate
 The need for additional training of research staff
 The need for a protocol amendment.

What to Do When a Protocol Violation Occurs?
Any concerns regarding participant safety must be addressed immediately by
staff at the study site.
The violation and a plan for corrective action must be documented.
The violation must be reported to
 The Principal Investigator at the site
 The Study Investigator
 Project Management (If Applicable)
 The Sponsor
 The FDA

Summary:
Standardization of procedures is critical
Not conducted in a standardized manner is unethical
Research protocol – A main documents - must be approved by a IRB before a research study
can begin.
Protocol amendment - change to some aspect of the study.
Amendments must be approved by the IRB.
Protocol violation - does not adhere to the study description in the research protocol.
 Each violation must be documented and action must be taken to correct the situation that
led to the violation.

REFERENCES:
• The Research Protocol – Good Clinical Practice of ICH
• Indian Council of Medical Research. Ethical Guidelines for Biomedical
Research on Human Participants. New Delhi: Indian Council of
Medical Research; 2017
• Good Clinical Practice for Clinical Research in India

RESEARCH PROTOCOL (Good Clinical Practices) by aks.pptx

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