WHO Recommended format for a Research Protocol (edited)
Part 1
Project summary
Like the abstract of a research paper, the project summary,
should be no more than 300 words and at the most a page long (font size
12, single spacing).
Preferably on a separate page, it should
summarize all the central elements of the protocol, for example the
rationale, objectives, methods, populations, time frame, and expected
outcomes.
It should stand on its own, and not refer the reader to points
in the project description.
General information
- Protocol title, protocol identifying number (if any), and date.
- Name and address of the sponsor/funder.
- Name and title of the investigator(s) who is (are) responsible
for conducting the research, and the address and telephone number(s) of
the research site(s), including responsibilities of each.
- Name(s) and address(es) of the clinical laboratory(ies) and other
medical and/or technical department(s) and/or institutions involved in
the research
Rationale and background information
The rationale specifies the reasons for conducting the
research in light of current knowledge.
It should include a well
documented statement of the need or problem that is the basis of the
project, the cause of this problem and its possible solutions.
It is the
equivalent to the introduction in a research paper and it puts the
proposal in context.
It should answer the question of why and what: why
the research needs to be done and what will be its relevance. The
magnitude, frequency, affected geographical areas, ethnic and gender
considerations, etc of the problem should be followed by a brief
description of the most relevant studies published on the subject.
References (of literature cited in preceding sections)
References can also be listed at the end of Part 1.
Study goals and objectives
Goals are broad statements of what the proposal hopes to
accomplish. They create a setting for the proposal.
Specific objectives are statements of the research question(s).
Objectives should be simple (not complex), specific (not vague), and
stated in advance (not after the research is done). After statement of
the primary objective, secondary objectives may be mentioned.
Study Design
The scientific integrity of the study and the credibility of
the study data depend substantially on the study design and
methodology. The design of the study should include information on the
type of study, the research population or the sampling frame, and who
can take part (e.g. inclusion and exclusion criteria, withdrawal
criteria etc.), and the expected duration of the study
(The same study can be described in several ways, and as
complete a description of the study as possible should be provided. For
example, a study may be described as being a basic science research,
epidemiologic or social science research, it may also be described as
observational or interventional; if observational, it may be either
descriptive or analytic, if analytic it could either be cross-sectional
or longitudinal etc. If experimental, it may be described as a
controlled or a non controlled study.
Methodology
The methodology section is the most important part of the
protocol. It should include detailed information on the interventions
to be made, procedures to be used, measurements to be taken,
observations to be made, laboratory investigations to be done etc. If
multiple sites are engaged in a specified protocol, methodology should
be standardized and clearly defined.
Interventions should be described in detail, including a description of
the drug/device/vaccine that is being tested. Interventions could also
be in the realm of social sciences for example providing training or
information to groups of individuals.
Procedures could be biomedical (collection of blood or sputum samples to
develop a diagnostic test), or in the realm of social sciences (doing a
questionnaire survey, carrying out a focus group discussion as part of
formative research, observation of the participant's environment, etc.).
Standardized or documented procedures and techniques should be described
and bibliographic references, if not documented earlier should be
provided. Instruments which are to be used to collect information
(questionnaires, FGD guides, observation recording form, case report
forms etc.) must also be documented.
In the case of a randomized controlled trial additional information on
the process of randomization and blinding, description of stopping rules
for individuals, for part of the study or entire study, the
procedures and conditions for breaking the codes etc. should also be
described.
A graphic outline of the study design and procedures using a
flow diagram must be provided. This should include the timing of
assessments.