Note To Users This Protocol Template Is Designed To

note to users this protocol template is designed to be generic. some subsections and suggestions will not be appropriate for your specific s

Note to Users
This Protocol Template is designed to be generic. Some subsections and
suggestions will not be appropriate for your specific study. You must
tailor the protocol contents to meet the needs of your study. Only
include sections pertinent to the study, omit irrelevant sections,
reorder and add sections as needed. Once you have finished your
template, don’t forget to highlight and right hand click on the
contents page and select “update all”, this will automatically update
the page and section numbers that have change. Please also ensure you
have deleted all of the annotations.
You are reminded that a protocol should be a standalone document. The
NEAF must be completed in addition to the protocol. The aim of the
NEAF is to ensure all ethical requirements in the National Statement
are satisfied, whereas a protocol should be a detailed description of
every aspect of your project. Therefore the two documents meet
different requirements.
protocol
[Insert Full study Title]
Protocol Number (if applicable):
Version: #
Date: DD/MM/YYYY
Author/s:
<>
Sponsor/s:
<>
CONFIDENTIAL
This document is confidential and the property of < Institution>>. No part of it may be transmitted, reproduced,
published, or used without prior written authorization from the
institution.
Statement of Compliance
This document is a protocol for a research project. This study will be
conducted in compliance with all stipulation of this protocol, the
conditions of the ethics committee approval, the NHMRC National
Statement on ethical Conduct in Human Research (2007) and the Note for
Guidance on Good Clinical Practice (CPMP/ICH-135/95).
Table of Contents
=================
Contents
========
Table of Contents 3
1. Glossary of Abbreviations & Terms 5
2. Study Sites 5
2.1 Study Location/s 5
3. Funding and Resources 5
3.1 Source/s of Funding 5
4. Introduction/Background Information 5
4.1 Lay Summary 5
4.2 Introduction 6
4.3 Background information 6
5. Study Objectives 6
5.1 Research Question 6
5.2 Primary Objectives 6
5.3 Secondary Objectives 6
5.4 Outcome Measures 6
6. Study Design 7
6.1 Study Design Diagram 7
6.2 Study Type & Design & Schedule 8
6.3 Standard Care and Additional to Standard Care Procedures 10
6.4 Randomisation 10
6.5 Study methodology 10
7. Study Population 10
7.1 Recruitment Procedure 10
7.2 Inclusion Criteria 11
7.3 Exclusion Criteria 11
7.4 Consent 11
8. Participant Safety and Withdrawal 11
8.1 Risk Management and Safety 11
8.2 Adverse Event Reporting 11
8.3 Handling of Withdrawals 11
8.4 Replacements 12
9. Statistical Methods 12
9.1 Sample Size Estimation & Justification 12
9.2 Power Calculations 12
9.3 Statistical Methods To Be Undertaken 12
10. Storage of Blood and Tissue Samples 12
10.1 Details of where samples will be stored, and the type of consent
for future use of samples 12
11. Data Security & Handling 12
11.1 Details of where records will be kept & How long will they be
stored 13
11.2 Confidentiality and Security 13
11.3 Ancillary data 13
12. Appendix 13
13. References 13
1.
Glossary of Abbreviations & Terms
---------------------------------
Abbreviation
Description (using lay language)
2.
Study Sites
-----------
1.
Study Location/s
[List all locations, their address & contact details this study or
parts of the study will be conducted]
Site
Address
Contact Person
Phone
Email
3.
Funding and Resources
---------------------
1.
Source/s of Funding
[This section should describe how the study will be financed, but
should not contain specific dollar amounts.]
4.
Introduction/Background Information
-----------------------------------
1.
Lay Summary
[All information provided in this section must be in language that can
be understood by an interested, intelligent person without a
scientific background. Do not use scientific jargon, abbreviations and
do not include journal citations in the lay summary. This summary
should include information on the aims and importance of the study as
well as briefly summarizing what will happen to the participants, the
time commitment required by the participants and how their safety will
be ensured.]
2.
Introduction
[The introduction is a very brief overview of the study (~250-500
words). The introduction should be concise but sufficient to orientate
the reader to the main purpose of the study and how it will be
conducted and its expected benefits. It should include details on (1)
What the research question is (2) How the proposed study will fill a
gap in the literature and (3) provide an understanding that this study
is novel]
3.
Background information
[This section should give clarity on the research question being
addressed. The information should convince the reader of why the study
needs to be done. The following points may be used as a guide:
*
Conduct a comprehensive literature search
*
Critically appraise the relevant literature and discuss the
current knowledge on the topic (include deficiencies). If
applicable, discuss the current treatment options and the
associated issues risks and benefits.
*
Indicate how the research question has emerged and fits logically
with the evidence detailed above.
*
Explain how your study will contribute to existing research and
benefit your target population.
*
Discuss the importance of the topic (e.g., public health, clinical
importance, community, incidence, prevalence, mortality and
morbidity)
5.
Study Objectives
----------------
1.
Research Question
[Clearly state the question the study intends to answer]
2.
Primary Objectives
[The primary objective reflects the main clinically relevant goal of
the study. Define the primary objective in terms of the population,
intervention, comparator, and outcome that will be measured in a
single clear and concise statement]
3.
Secondary Objectives
[A study may or may not have secondary objectives. Secondary
objectives consider outcomes of interest that may or may not be
related to the primary objective. Secondary objectives may include
more general non-experimental objectives e.g., to develop a registry,
to collect medical history data]
4.
Outcome Measures
[This section of the protocol must clearly state what the variables to
be measured are. The primary outcome measure should reflect the
clinically relevant effects of the intervention and be based on the
primary objective of the trial. There should only be one primary
outcome.
The secondary outcome measures are other effects to be measured in the
study, these may or may not be related to the primary objective and
are based on the secondary objectives.
Since the outcome variables will be used to evaluate the success or
otherwise of the intervention, they need to be carefully selected and
clearly defined in the protocol. Ensure endpoints are obtainable.
Efficacy variables are usually a quantitative measure of a clinical
effect. Often the clinical effect to measure is obvious, but the
method of measurement may be controversial. A surrogate endpoint does
not measure the clinical effect, but is something that can be measured
that is thought to relate to the clinical effect (e.g. bone density is
related to a reduced fracture rate). Provide justification for any
surrogate endpoints.
If a composite endpoint will be used explain its composite parts.
Primary and secondary outcome measures may be:
*
Objective assessments (e.g. mortality rates);
*
Subjective clinical assessments (e.g. validated rating scales);
*
Measurements of various physiological functions (e.g. blood
*
pressure);
*
Anatomical or histological assessments (e.g. tumour measurements)
*
Biomarkers or biochemical markers (e.g. tumour markers, liver
*
function tests); or
*
Pharmacokinetic tests.]
6.
Study Design
============
1.
Study Design Diagram
[To increase readability, include a flow chart of the study design.
The following are examples:]




2.
Study Type & Design & Schedule
[The description of the study design should be capable of meeting the
study objectives. A thorough description of ALL study procedures and
assessments in a logical and sequential format]
1.
Specify the type of study e.g., Cohort-study (retrospective or
prospective), case-control study, cross-sectional study
2.
Specify the basic design elements including the population to be
studied (e.g., Adults aged 18-35), any risk factors present
3.
Specify if this study will be a single-centre or multi-centre
(national or international) study.
4.
Specify how the design will achieve the aims and objective
5.
Please state what data will be collected e.g., blood tests, MRI’s,
genetic testing, videos, photos, questionnaires etc... For each
item, specify if the data collected will be identifiable,
re-identifiable or non-identifiable.
6.
Describe how you will collect, handle and store all types of data
collected.
7.
Specify the time frame for each component of the study, this
should include study visits, how long recruitment is open for and
how long analysis will take etc..
8.
Specify if the study requires any home visits, and what the home
visit policy and procedures are.
9.
Ensure you have included all information on all required
contingency plans within your study outline.
10.
State if this protocol will be used towards a student project, and
if so, state what course and degree the student will undertake.
11.
Provide a flowchart or table specifying visits, interventions and
other relevant details
EXAMPLE STUDY TABLE
Example procedures
Assessment/Procedure
Screening
Visit 1
(3 months)
Visit 2
(12 months)
Follow-up
Informed Consent
x
Demographic Information
x
Weight Measurement
x
MRI
x
x
QOL50- questionnaire
x
x
x
Blood Collection
x
x
x
Biopsy
x
3.
Standard Care and Additional to Standard Care Procedures
[In table format LIST all procedures, assessments, and tests (e.g.,
CT-scans, MRI, blood tests etc…) that form part of standard care and
that are additional to standard care. Include testing times, dosages
and volumes where applicable]
Standard Care Procedures
Additional To Standard Care
Procedure
Time/Visit
Dosage/Volume
Procedure
Time/Visit
Dosage/Volume
4.
Randomisation
[Include a description on how your participants will be randomisation,
include any software that will be used. Where applicable, a
description of the type of ranomisation performed, ratio of assignment
to group and stratification should be included. An explanation on the
method used to conceal group allocations should be included and who
will assign participants to their groups. This section should also
discuss if the participants and/or investigators will be blinded to
group allocations or if the study will be unblinded to the
participants and/or investigators]
5.
Study methodology
-----------------
[Describe each clinical or laboratory assessment/s that will be
carried out as part of this study. This should include a procedures
list that details what information will be collected. If you are using
standardised surveys, questionnaires or other test please attach a
copy of each of these tests to the appendix of the protocol]
7.
Study Population
----------------
1.
Recruitment Procedure
[Define the group in which the study will be carried out on. Explain
how participants will be identified and recruited. You should make a
distinction between how you will recruit control subjects compared to
other groups.]
Cohort Studies: Describe sources and methods that will be employed in
the identification and recruitment of potential participants e.g.,
clinics, referring doctors, advertisements etc…
Cross-sectional Studies: Describe the sources and methods that will be
employed in the identification and recruitment of prospective
participants (e.g., clinics, referring doctors, advertisements etc…)
and retrospective data (e.g., medical records, registries, databases
etc...)
Case-Controlled studies: Describe how controls will be identified and
recruited (e.g., advertisements, letters from GP’s, family members
etc...), and describe how they will be matched. Describe how the study
population will be identified and recruited, and then provide a
justification for how bias has been avoided.
2.
Inclusion Criteria
[Clearly describe the study population that is required for a subject
to be included in the study. The criteria may be based on factors such
as age, gender, type and stage of disease, previous treatment history
etc...]
3.
Exclusion Criteria
[Provide details of participants that will be considered ineligible to
participate and justify why they have been excluded. Exclusion
criteria may include an inability to give informed consent, understand
English, contraindications of the study treatment and/or procedures,
conditions that will hinder the participant’s ability to comply with
the study protocol].
4.
Consent
[Describe if individual consent will be obtained or if a waiver of
consent is required, or if no consent is required]
8.
Participant Safety and Withdrawal
=================================
1.
Risk Management and Safety
[Identify all areas where participant safety may be compromised,
safety such examples may include, but are not limited to exposure to
radiation and invoking psychological or physical distress. Safety
considerations are not just physical, they can also be psychological,
therefore, you must ensure for psychological distress you have
arranged an appropriate contingency plan.]
2.
Adverse Event Reporting
[If applicable, provide a description of how adverse events will be
defined for your study. Include how adverse events occurring in the
study subjects are to be identified and reported. Details should
include the definition of a serious adverse event (SAE) and reporting
timeframes.
3.
Handling of Withdrawals
[Participants may withdraw from the study for the following reasons:
participant has chosen to withdraw from the study, protocol violation,
or participant has experienced an adverse event. Describe the
procedures to be followed when a participant is withdrawn from the
study. This should include what happens to all collected data (e.g.,
blood samples, scans, photos, etc…) that have already been collected,
if the participant needs to have any follow-up, all administrative
requirements to withdraw a subject to ensure their information isn’t
inappropriately used after their withdrawal from the study]
4.
Replacements
[Describe if withdrawn participants will be replaced in the study and
if not, describe what impact this will have on the statistical
significance of the sample size for the study]
9.
Statistical Methods
===================
1.
Sample Size Estimation & Justification
[Specify the estimated sample size and justify how this sample size
will ensure that your study numbers will reach statistical
significance]
2.
Power Calculations
[Describe and detail how the power calculations were obtained.]
3.
Statistical Methods To Be Undertaken
[Describe the statistical methods that will be undertaken for this
study. It is recommended this section is written in collaboration with
a statistician.]
10.
Storage of Blood and Tissue Samples
===================================
1.
Details of where samples will be stored, and the type of
consent for future use of samples
--------------------------------------------------------
[Describe what samples are taken, how long you will store each sample,
where you will store the sample and state if any samples will be used
for genetic testing. Finally describe if samples will be entered into
a biobank, and if consent from participants will be for this research
project only, for future projects related to this, or if participants
have given unspecified consent.]
11.
Data Security & Handling
========================
1.
Details of where records will be kept & How long will they be
stored
[List the location/s where records will be held. If there are multiple
locations, list the exact data to be held at each location. All
records for non drug trials should be kept for a minimum of 7 years
post study closure, if your study contains a CTN device, then records
must be kept for a minimum of 15 years.]
2.
Confidentiality and Security
[Describe how confidentiality of all study data will be ensured via
security mechanisms in place.]
3.
Ancillary data
[Describe how where and for how long you will store data such as
videos, photographs and images, also describe how confidentiality will
be ensured].
12.
Appendix
========
[Attach any questionnaires, functional and/or cognitive tests,
surveys, telephone scripts, advertisements, photographs of devices
etc….].
List of Attachments included:
Document Name
Version Number
Date (e.g., 18 January 2012)
13.
References
==========
Study Name: <>
Protocol Number: <>
Version & date: version X, dated Day Month Year Page 13 of 13