PROTOCOL OVERVIEW

A protocol or research proposal is the "recipe" according to which a research
project will be executed. It describes in detail the motivation for performing the
study, and the procedure whereby it will be performed. A well-planned protocol
is the key to success for any research. Protocols which are well prepared are
also more likely to be successful when applying for financial support. It is
important to execute the project strictly according to the final protocol.
Here follows a short description of each component of the protocol.
The components as described here, cover the aspects which should be
addressed in any protocol. Different organisations set their own requirements
as to the structure of the protocol (sequence, headings). You thus do not
necessarily have to use the components indicated here in this specific order, but
you should give attention to all these aspects in the protocol.

1. TITLE

The protocol title is based on the aim or question as outlined below. It is
important to keep the title concise, on the one hand, but on the other hand it
must be sufficiently descriptive to give the reader a good indication of what the
study is about. Often a lot of time is spent to formulate the title correctly, and
this should be done after the contents of the protocol have been written.
Each version of the protocol should be dated.

2. RESEARCHERS

The researchers (sometimes with their curriculum vitae as addendum) and
where they work, must be listed. Since these persons can claim co-authorship
when the study is published, consideration must be given to the composition of
this group. For applications for financial support a lot of detail about these
researchers is usually requested, including publications, previous research and
posts, as well as the available facilities and co-operation with other units /
researchers.

3. INTRODUCTION

Here the literature study is summarised. Indicate and discuss what has already
been published on this topic, and emphasise the possible controversies,
difficulties or questions. Formulate the problem you want to address in your
research and motivate why it is important to do the planned study. (This section
can later be used as the introduction to the research publication.) One should
use relevant, recent references from reputable sources and indicate them using
a standard reference style consistently. .

4. RESEARCH QUESTION/AIM AND OBJECTIVES

For each project a clear aim should be formulated. An easy way to state an aim
simply is to phrase it as a single question. The aim should indicate what will be
investigated, where and in whom. The specific objectives of the study to achieve
the aim should also be listed.

5. METHODOLOGY

  

5.1 STUDY DESIGN

Here one must indicate which type of study design (for example descriptive
study, case-control study or clinical trial) will be performed. The chosen study
design must be the most appropriate to achieve the aim (or answer the research
question). One must consider the likelihood of achieving results, given the
available infrastructure, funds and time.

5.2 SAMPLE / STUDY PARTICIPANTS

The population (the group about which the research question must be answered)
must first be defined and an indication given of the population size. Then it must
be described whether and how a sample (subgroup) will be selected from the
population to reflect the population satisfactorily. This selection is extremely
important. An error here can lead to large biases (errors in results). If, however,
the sample is chosen correctly, a lot of work can be saved since it is much easier
to study 200 people (sample) than 2000 (population).

Where appropriate, criteria by which participants will be included or excluded,
must be stated.

If no specific sampling method will be used, it must be indicated how study
participants will be obtained (for example by approaching consecutive patients
at a clinic for a specific time period).

The size of the sample must be indicated. This must be determined before the
study starts. A statistician can give advice in this regard. However, practical
considerations often determine the eventual size of a sample, but if the sample
is too small, the results of a project may not be valid.

5.3 MEASUREMENT

After you have indicated who you will study to try to answer the research
question, you must indicate which procedures will be performed and what
information will be collected. The procedures to obtain the information are called
“measurement” and can consist of, amongst others, questionnaires, interviews,
measurements with the aid of apparatus or the analysis of specimens in a
laboratory.

It is important to describe the measurement process in detail and to indicate
which researcher(s) will be responsible for which measurement tasks and where
these measurements will be done. If someone wants to repeat the study at a
later stage, the description should be so clear that he / she will be able to do the
measurements in exactly the same way. A flow chart can be very useful.
If interviews or questionnaires are used, you have to indicate in which languages
they will be available.

5.4 METHODOLOGICAL AND MEASUREMENT ERRORS

The errors which can crop up in a specific study, as well as the methods the
researchers will use to try and prevent these errors, must be described. Errors
usually consist of variation, bias and/or confounding variables.

5.5 PILOT STUDY

A pilot study is a trial run (for example testing the questionnaire or other
measurement procedures) whereby the methodology is tested and refined.
Indicate in the protocol whether a pilot study is planned, on how many
participants and where. Also clearly indicate which aspects of the methodology
will be tested in the pilot study and whether pilot study results will be included in
the main study. The pilot study is only performed after the ethics committee has
approved the protocol.

6. ANALYSIS

The type of statistical analysis and who will be doing the analysis must be stated
here (if necessary you must ask the advice of a statistician). It is good practice
to briefly outline the way in which the results will be presented (for example in
tables). This will help to ensure that all the necessary and only the necessary
information will be collected.

7. IMPLEMENTATION OF FINDINGS

Here you indicate what you will conclude from the results and how you will
implement the findings. If this has already been stated as part of the motivation
in the Introduction, you need not state it here as a specific paragraph.

8. TIME SCHEDULE

An estimate of the time it will take to complete the entire project must be given.
This includes the planning and execution of the project, as well as writing up the
study as a report or publication. Here you can also indicate which researcher
will be responsible for which aspect.

9. BUDGET

The costs should be calculated and outlined precisely and an indication of the
funding sources given.

10. ETHICAL ASPECTS

All research projects must be approved by the ethics committee of the relevant
institution before the study commences. In the protocol you must indicate which
steps will be taken to ensure ethical conduct, for example informed consent by
participants, anonymity or confidentiality of information, ethics committee
approval, permission from appropriate authorities and declaration of conflicts of
interest .

11. REFERENCES

The references which are cited in the protocol must be listed using a recognised
and appropriate referencing system (for the specific field of study).

12. APPENDICES

Examples of the planned questionnaires, data forms, information sheet for
participants, consent forms (if appropriate for the study) and permission letters
are attached as appendices to the protocol.