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Research Protocol

The research protocol must clearly describe: 1) Why the study is being done 2) What will be done in the study 3) Who is involved in the research study It then provides detailed sections on study objectives, design, selection and withdrawal of participants, treatment, assessment of efficacy and safety, statistics, quality control, ethics, data management, and other administrative elements. The protocol establishes the plan to ensure the scientific integrity and credibility of the research.

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28 views

Research Protocol

The research protocol must clearly describe: 1) Why the study is being done 2) What will be done in the study 3) Who is involved in the research study It then provides detailed sections on study objectives, design, selection and withdrawal of participants, treatment, assessment of efficacy and safety, statistics, quality control, ethics, data management, and other administrative elements. The protocol establishes the plan to ensure the scientific integrity and credibility of the research.

Uploaded by

gracelin femi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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RESEARCH PROTOCOL

The research protocol must clearly and


succinctly describe the following aspects of
the research study:

Why the study is being done.


What will be done in the study.
Where the study will be done (for multi-site
trials, site-specific information may be
incorporated).
Who is involved in the research study? When
study interventions will take place.

CONTENTS RESEARCH PROTOCOL


1. General Information
2. Background Information
3. Study Objectives and Purposes
4. Study Design
5. Selection and Withdrawal of Participants
6. Treatment of Participants
7. Assessment of Efficacy
8. Assessment of Safety
9. Statistics
10. Direct Access to Source Data or
Documents
11. Quality Control and Quality Assurance
12) Ethics
13) Data Management
14) Financing and Insurance
15) Publication Policy
16) Supplements

GENERAL INFORMATION
1. Protocol title, identifying number, version
number, and date. Name and address of
the sponsor and monitor (if other than the
sponsor).
2. Name and title of the person authorized
to sign the protocol and the protocol
amendments for the sponsor.
3. Names and titles of the investigators
responsible for conducting the study, and
the address and telephone number of the
trial sites.
4. Name, title, address, and telephone
number of the sponsor’s medical expert.
5. Name, title, address, and telephone
number of the qualified physician who is
responsible for all study– related medical
decisions.
6. Names and addresses of all institutions
involved in the study (including clinical
laboratories and other medical or technical
departments).
7. Addresses and telephone numbers of all
clinical laboratories and/or institutions
involved in the trial.
BACKGROUND INFORMATION
1)A description of the issue the study is
addressing as well as its public health
significance.
2) Findings from clinical or nonclinical studies
that may be significant to the proposed
study.
3) Summary of the known potential risks and
benefits to human participants.
4) A statement that the trial will be conducted
in compliance with the protocol, GCP, and the
applicable regulatory requirement(s).
5) Description of the study population.
6) References to relevant literature and data
(this will often be compiled in a separate
section in the protocol).
7) If the study involves the use of an
investigational product or therapy:
A) Name and description of the
investigational product or therapy.
B) Description of and justification for the
route of administration, dosage, dosage
regimen, and treatment period(s).

STUDY OBJECTIVES AND PURPOSES

A detailed description of the major (primary)


and minor (secondary and exploratory)
objectives and the purpose of the trial.

STUDY DESIGN
The scientific integrity of the study and the
credibility of the data obtained from the
study largely depend on the study design. This
section of the protocol should describe:
1. Primary and secondary endpoints to be
measured and how they will be measured.
2. Study type (e.g., double-blind) and
measures that will be taken to avoid or
minimize bias (e.g., randomization,
blinding).
3. Dosage and dosage regimen, dosage form,
packaging, and labelling of investigational
products.
4. Accountability procedures for the
investigational product, including the
placebo and comparator.
5. Maintenance of study treatment
randomization codes and procedures for
breaking codes.

END POINT IN CLINICAL TRIALS

An endpoint is the primary outcome that is


being measured by a clinical trial.
A cancer drug, for example, might use
survival as an endpoint, comparing the
five-year survival rate of patients using an
experimental therapy against the five-year
survival rate of patients using another
treatment or a placebo.
SELECTION AND WITHDRAWL OF THE
PATIENTS

1. Criteria for inclusion and exclusion of


participants.
2. Procedures for withdrawal of participants
(participant or investigator-initiated):
When and how to withdraw participants
from the study/investigational product
treatment.
3. Type and timing of data to be collected for
participants who withdraw from the study.
Whether and how participants are to be
replaced.
4. Follow–up for participants withdrawn
from trial treatment.

TREATMENT OF PARTICIPANTS

1. Pharmacological treatment
2. All interventions

ASSESSMENT OF EFFICACY
This section describes the methods that will
be used to determine the success of the
treatment, including:
1) Criteria for determining the treatment’s
effectiveness.
2) Methods and timing for assessing,
recording, and analysing the effectiveness
criteria.

ASSESSMENT OF SAFETY
This section describes how the study will be
monitored and how adverse events will be
dealt with.

1) Specification of safety criteria.


2) Methods and timing for assessing,
recording, and analysing the safety criteria.
3) Procedures for obtaining reports of adverse
events and illnesses experienced by
participants during the study period and for
recording and reporting these events,
including expedited reporting procedures.
4) Type and duration of follow–up of
participants who experience adverse events.

STATISTICS

This section describes the strategy for


analysing the data collected during the
study, including:
1. Statistical methods to be employed,
including the timing of any planned
interim analyses.
2. Total number of participants to be
enrolled.
3. Reason for the choice of sample size.
4. Level of significance to be used.
5. Criteria for termination of the study.
6. Procedure for accounting for missing,
unused, and false data.
7. Procedures for reporting deviations
from the statistical plan
8. Selection of participants to be included
in analyses

DIRECT ACCESS TO SOURCE DATA


The sponsor should ensure that the protocol
or other written agreement specifies 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.
QUALITY CONTROL AND QUALITY
ASSURANCE
A detailed quality assurance plan describing
the set standards and controls that are in
place to confirm that the execution of each
step follows the agreed upon plan is usually
submitted as a separate document.

ETHICS
This section should describe ethical
considerations relating to the study and
measures taken to protect human
participants and maintain confidentiality of
study data.

DATA MANAGEMENT
A detailed data management plan describing
the way study data will be gathered,
documented, submitted, verified, and
archived is usually submitted as a separate
document.

FINANCING AND INSURANCE


This section describes how the study will be
financed and insured. In some research
networks, these issues are addressed in a
separate agreement and need not be
included in the protocol.

PUBLICATION POLICY

This section describes the 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.

SUPPLEMENTS
This section supplies any additional
information that may be required, depending
on the nature of the research. For example,
the informed consent template, the therapy
manual, a patient information handbook, etc.,
may be included as attachments.

PROTOCOL AMENDMENT
A protocol amendment is a written
description of a change to some aspect(s) of
the study as described in the research
protocol.
Protocol amendments must be submitted in
writing to the designated Institutional Review
Board (IRB) and must be approved by the IRB
before they can be implemented, except
when necessary to eliminate immediate
hazards to the participants or when the
change involves only logistical or
administrative aspects of the trial (e.g.,
change of monitor, telephone number.
A protocol amendment is not to be confused
with a “protocol clarification.” A protocol
clarification aids in the implementation or
conduct of the study and provides internal
guidance. It does not change the protocol or
alter the risk-benefit ratio of the study. A
protocol clarification generally does not need
to be submitted to the IRB. A clarification
should be provided in writing to all
investigators.

PROTOCOL VIOLATION
A protocol violation occurs whenever a study
staff person performs any action that does
not adhere to the research protocol. Protocol
violations are sometimes referred to as
protocol "deviations." Although "deviations"
may sound less serious than “violation,” the
two terms are identical.

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