A GUIDE TO WRITING A RESEARCH PLAN
The purpose of this template is to assist researchers in planning and conducting their
research projects. It is important to note that:
 A well-written and complete Research Plan is essential for achieving a high quality
research study.
 Time spent on writing a detailed Research Plan will avoid problems during the
study conduct, and will make publishing the results easier.
 A complete Research Plan is also essential for the study to be approved by the
ethics committee.
 Where ACT data collections are used, a copy of the research plan should be
included with any request to access data.
The following is a tool to facilitate the development of a Research Plan. It will provide
guidance on the subject headings and details required in a Research Plan. Not all of
these sections will be relevant for every research project and the exact form of your
Research Plan will depend on the specific study design.
General comment
 Include page numbering in the footer (eg, 1 of 10, 2 of 10 etc as shown in this
document
 Include the version number and date in the footer (eg, version 1 dated 8 August
2014) as shown in this document
 Ensure the title of the research project is consistently referred to throughout the
Research Plan and related documents, (eg Participant Information and Consent
Form, ethics application etc)
Using this template
 Content presented in Italics is for reference only and must be deleted from the
final Research Plan
 When the document is completed, update the “Table of Contents” by clicking on
the table and selecting ‘Update Field’, then select ‘Update Entire Table’
Page 1 of 5
Research Plan # Version & date
“Title of Research Project”
Short title (if applicable)
Investigators & personnel (and their affiliations)
principal investigator
Other investigators
Study Personnel
Institution(s) responsible for the running of the study
Contents
1.
Synopsis ............................................................................................................................. 3
2.
Abbreviations and Acronyms............................................................................................... 3
3.
Introduction / Background ................................................................................................... 3
4.
Objectives ........................................................................................................................... 3
5.
Hypothesis .......................................................................................................................... 3
6.
Study Methodology ............................................................................................................. 3
7.
Study population ................................................................................................................. 4
8.
Study procedure.................................................................................................................. 4
9.
Statistical Analysis .............................................................................................................. 4
10.
Quality assurance, monitoring & safety ........................................................................... 5
11.
Ethical Issues .................................................................................................................. 5
12.
Finance and resource use ............................................................................................... 5
13.
Dissemination of Results and Publication policy .............................................................. 5
14.
References ...................................................................................................................... 5
15.
Appendices ..................................................................................................................... 5
Page 2 of 5
Research Plan # Version & date
1. Synopsis
This is similar to an abstract and should be about the same length (250-300 words). It
acts as a standalone summary of the study. It generally consists of 1-2 sentences
background then the concise objective or aim followed by a brief outline of description of
participants, intervention, methods, outcome measures and proposed analysis.
2. Abbreviations and Acronyms
List Abbreviations and Acronyms
3. Introduction / Background
This should include the following:
 Introduction to the topic of interest.
 What is known already - literature review of relevant findings (Brief and focused)
 Highlight area where there is missing information in the literature
 State the aims of this study– what the study is going to find out, and in one
sentence how this is going to be achieved.
 Impact - this is where you indicate how the study will substantially add to science,
change practice, save money and best of all save lives or improve quality of life in
substantial numbers of people. Include an economic impact if possible. (note
impact is sometimes placed at the end of the protocol)
 A handful of relevant references
The background should not be an exhaustive literature review. At the end the reader
should have a clear idea of the research question, an understanding that it is original
and relevant, and how this research will help fill the gap in the literature.
4. Objectives
 Clear statement of primary and secondary objectives of the study
5. Hypothesis
 Include a clearly defined hypothesis here
6. Study Methodology
 Describe study
o Type of study
o Where is it going to be carried out (also known as setting)
Page 3 of 5
Research Plan # Version & date
o Sample size calculation or justification of numbers (Should be based on
previous data )
7. Study population
 Subjects
o Source of participants - where and when are you going to recruit them?
o Is the number of participants a realistic expectation from your site?
o How many participants?
o Inclusion/Exclusion criteria
8. Study procedure
 Patient informed consent process (including waiver of consent if required)
 Outcome (Note there should be only one primary outcome)
o What are the primary and secondary outcomes
o Details of the outcome measures used
 Data Collection
o What data are you going to collect, how is it collected, who collects it and
when?
o Details of all demographic data and other potentially confounding data
o Source of data
o Variables
o Privacy and confidentiality
o Secure data storage
o Will there be any attempts to de-identify data?
 Further subject follow-up, if applicable
o When and for what? Especially for adverse events
o How often?
o What data is collected at each time point?
 Study timelines: Expected duration of the study& start times
 Risk / benefit
9. Data Analysis
 Analysis plan
o Details on how the primary and secondary outcomes will be analysed.
o Statistical methods to be used (qualitative; quantitative; mixed methods)
o Who is going to carry out the analysis?
Page 4 of 5
Research Plan # Version & date
10.
Quality assurance, monitoring & safety
 Any external committees overseeing the study such as Study Steering Committees
or Data and Safety Monitoring Board?
o Will there be an interim analysis?
11.
Ethical Issues
 Consent
o Identify and justify any dual relationships, coercion or inducement
 Ethics Review
 Regulatory Compliance
 Peer Review
 What goes beyond standard practice?
o Identify and justify any non-negligible risk or burden
12.
Finance and resource use
 Details of funding bodies
 Duality of Interests
 Budget including direct and indirect costs
13.
Dissemination of Results and Publication policy
 The research plan should specify not only dissemination of results in the scientific
media, but also to the community and or the participants, and consider
dissemination to the policy makers where relevant. Where ACT Health data
collections are being used researchers many be required to provide a copy of any
proposed publication to the data custodian for comment. Publication policy should
be clearly discussed - for example who will take the lead in publication and who
will be acknowledged in publications, etc.
14.
References
15.
Appendices
Page 5 of 5
Research Plan # Version & date