Info on the document

Study protocol can be developed in free format (as you like), as long as all relevant information is
provided in structured and transparent manner. Present document outlines some general
requirements and recommendations, and can be used as guide in developing individual protocol for
submission.

This document can be used as a template. In this case you should remove the first page, and also all
the explanatory text in Green. Your final study protocol should include only the information relevant to
your study.

If you are certain that an item (section) does not apply, please state "NA" and provide a short (1-2
sentences) explanation. It is not recommended to remove an item, leave it blank or state “NA” without
an explanation.
University of Georgia
Summer Semester 2022

STUDY PROTOCOL FOR SMALL CLINICAL RESEARCH

Title
Descriptive title; identifying the study design, population, interventions.

Author(s)
Student name (First name, last name), (IM number)

Names of other contributors (if any).

Abstract
Trials guidance: The Abstract should be min 250 and max 300 words. Please minimize the use of
abbreviations and do not cite references in the abstract. The abstract must include the following
separate sections:

• Background: the context and purpose of the study

• Methods: how the study will be performed
• Discussion: a brief summary and potential implications

Keywords
Provide 3-5 keywords relevant to the study.
Body of the manuscript (including the Introduction, Methods and analysis, and Expected results)
should be max 2000 words (not including tables and figures).

INTRODUCTION
Background and rationale
Provide context around the study. Provide summary of relevant studies (5-10 references).
Demonstrate a problem or a gap in knowledge, a justification for study objectives.

Objectives
Clearly state specific objectives or hypotheses of the study.

METHODS AND ANALYSIS

Provide a full description of the study design, likely including the following.
 Description of study settings (eg, community clinic, academic hospital, organization) where
data will be collected.
 Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centers
and individuals who will perform the interventions (eg, surgeons, psychotherapists).
 Who will obtain informed consent from potential participants, and how;
 How the sample will be selected; the sample size calculation (drawing on previous literature)
with an estimate of how many participants will be needed for the primary outcome to be
statistically, clinically and/or politically significant;
 What outcomes will be measured, when and how; interventions to be measured; Provide
information on any instruments (e.g. measurement instruments, questionnaires) or tests used
in the study. Explanation of the clinical relevance of chosen data sources and instruments is
strongly recommended.
 How personal information about potential and enrolled participants will be collected, shared,
and maintained in order to protect confidentiality.
 A data analysis plan. Describe planed strategy for analyzing primary and secondary
outcomes. Reference to where other details of the statistical analysis plan can be found, if not
in the protocol.
Exposure:
Outcome:
Inclusion criteria:
Exclusion criteria:

EXPECTED RESULTS
Describe what benefit can be expected if the study is successfully implemented.

DECLARATIONS (Optional)
This section may contain the following subheadings:
Acknowledgements; Authors' contributions (distribution of responsibilities); Funding (if available);
Ethics approval and consent to participate (if available); Conflict of interests
REFERENCES

It is recommended to use APA citation and reference style. Different style can be used, as long as
citation and reference style is consistent throughout the document.

 Citations in the text should indicate (first author, year) or (organization, year).

 References should be organized alphabetically.

 Original research articles and reviews should represent majority of the references. Using
textbooks should be avoided where possible.

 Using Web links and URLs is generally not recommended. If used, all web links and
URLs should be provided in full, including both the title of the site and the URL, as well as the
date the site was accessed. Example: “BMJ Open Authors.
https://bmjopen.bmj.com/pages/authors. Accessed on 29 April 2022.”

 At least 50% of all references should be from recent 5 years.