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Research Protocol Writing Guide

This document outlines the format and guidelines for writing a research protocol at Al-Azhar University Faculty of Dental Medicine in Cairo, Egypt. It specifies that the protocol should include an English and Arabic cover page with the title, candidate name, and supervisors. The main body should contain an introduction, aim, methodology, consent form if needed, references, and supervisors in Arabic. The methodology section describes the required components, including study design, setting, population, sample size calculations, interventions, observations, ethical considerations, data management, and references in a specific format. Protocols must be submitted to the Vice Dean by the third Thursday of each month.
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0% found this document useful (0 votes)
79 views9 pages

Research Protocol Writing Guide

This document outlines the format and guidelines for writing a research protocol at Al-Azhar University Faculty of Dental Medicine in Cairo, Egypt. It specifies that the protocol should include an English and Arabic cover page with the title, candidate name, and supervisors. The main body should contain an introduction, aim, methodology, consent form if needed, references, and supervisors in Arabic. The methodology section describes the required components, including study design, setting, population, sample size calculations, interventions, observations, ethical considerations, data management, and references in a specific format. Protocols must be submitted to the Vice Dean by the third Thursday of each month.
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Al-Azhar University

Faculty of Dental Medicine, Cairo, Boys


Committee of Graduate Studies and Research (CGSR)
2017 / 2018

Format for the Research Protocol Writing

The research protocol is generally written according to the following format:


• English cover page includes the research title, candidate name, department
and supervisors.
• Introduction.
• Aim of the study.
• Methodology.
• Consent form if needed.
• References.
• Arabic cover page and supervisors in Arabic.

General guidelines:
1. Please read well "How to submit a research protocol" and "Format for
the research protocol" available in your department before start writing
your protocol.
2. The thesis supervisory committee and head of department are the only
sides that carry the commitment of directing this format perfectly.
3. Protocol writing should be of font size 14, Times New Roman font
face and 1.5 line space on A4 page size.
4. The numerical dates in Arabic cover page should be in Arabic
numerals.
5. The introduction, aim and methodology should not exceed 6 pages.
6. Submit your protocol signed by supervisory committee to the Vice
Dean for Graduate studies on the 3rd Thursday of the month for 10 days.
Protocols submitted beyond that date will be postponed to the next
month. This format will be valid in Dec 1st 2017.

1
Title: The title should explain the project. It should be descriptive and concise

Protocol submitted in partial fulfilment of the requirements for Master or Doctor


Degree in ...speciality...
By
.....Candidate name....
BDS, ..year.. G, Faculty of .........., .............. University
MDSc, ..year.. G in ...speciality..,
Faculty of .................., ................... University
...position.., ....working place......

Supervisors

Dr. ..........primary supervisor name............ Dr.........secondary supervisor name.....................

Professor, Department of ...speciality.... Lecturer, Department of ...speciality....

Faculty of Dental Medicine, Boys, Cairo Faculty of Dental Medicine, Boys, Cairo

Al-Azhar University Al-Azhar University

Department of ......speciality....
Faculty of Dental Medicine, Boys, Cairo
Al-Azhar University
143 H- 201 G

2
Introduction

1. Why the research needs to be done?

2. What will be its relevance?

▪ It should include a well documented statement of the problem that is


the basis of the project, the cause of this problem and its possible
solutions.
▪ A brief description of the most relevant studies published on the
subject should be provided to support the rationale for the study.

3
Aim of the study

1. State the purpose of the study in a single sentence.


2. Objectives should be simple (not complex), specific (not vague), and stated
in advance (not after the research is done).
3. After statement of the primary objective, secondary objectives may be
mentioned.

4
Materials and methods

Study design:

The methodology section of the protocol starts with the description of the
study design; it may 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.

Study setting and population:

This includes information regarding site of the study, e.g. dental school,
hospital or community based, single or multiple site study. The target population of
the study should be well defined.

Eligibility criteria of population:

This describes the inclusion criteria, exclusion criteria, and criteria for
discontinuation.

Sample size:

This explains how the sample size will be calculated, the power of the
sample and how subjects will be recruited. The basis on which sample size is
calculated should be explained here.

Interventions:

The methods section should be organized under meaningful subheadings and


describe techniques used in sufficient detail. Established methods should be
referenced but no description is necessary. For published but not well known

5
methods, a reference as well as a brief description should be given. New or
substantially modified methods should be clearly described, with reasons given for
using them and with their limitations outlined.

Observations:

Information should be provided on the observations to be made, how they


will be made, and how frequently will they be made. If the observation is made by
a questionnaire, this should be appended to the protocol. Laboratory or other
diagnostic and investigative procedures should be described. For established
procedures, reference to appropriate published work is enough. For new or
modified procedures, an adequate description is needed, with a justification for
their use.

Ethical consideration:

If human subjects are involved in the study, it should be stated that the
research protocol is approved by the ethical committee, Faculty of Dental
Medicine, Al-Azhar University and that the enrolled patients should sign a written
consent form.

For animal studies approval is required from the animal welfare committee
of the institute or its equivalent. If no such committee exists, a statement signed by
the principal investigator(s) should indicate that the research will be carried out in
accordance with the International Guiding Principles for Biomedical Research
involving Animals.

6
Data management and analysis:

This should provide information on how the data will be managed, including

data coding for computer analysis, monitoring and verification. Information should
also be provided on the available computer facility. The statistical methods used
for the analysis of data should be clearly outlined. It is good to document the
software program with version to be used.

References: The protocol should end with a list of relevant references on the
subject.
• The references should be cited in the Vancouver style.
• The journal titles should be abbreviated, as is the practice in most but
not all journals.
• List of journals abbreviation can be accessed through (http:
//[Link]).
• List the names and initials of the authors, as it appear in the original
article, up to six authors.
• If more than six authors, list the first six authors followed by et al.
• Book as a reference: authors' names. title of the book . ed .. , place
of publication : publisher ; year of publication.
• Chapter in a book as a reference: authors of the chapter. Chapter title.
In: authors of the book. Title of the book. . ed .. , place of
publication : publisher ; year of publication. p 11-44.

Examples:

Up to six authors:
Zakhary I, El-Mekkawi H, Elsalanty M. Alveolar ridge augmentation for implant
fixation: status review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2012;
114: S179-S89.

7
More than six authors:
Wang S, Zhang Z, Zhao J, Zhang X, Sun X, Xia L et [Link] alveolar ridge
augmentation with β-tricalcium phosphate and autologous osteoblasts in canine
mandible. Biomaterials 2009; 30:2489-98.

Book as a reference:
Ringsven MK, Bond D. Gerontology and leadership skills for nurses. 2nd ed.
Albany (NY): Delmar Publishers; 1996.
Chapter in a book as a reference:
Phillips SJ, Whisnant JP. An introduction to gerontology. In: Ringsven MK, Bond
D, editors. Gerontology and leadership skills for nurses. 2nd ed. Albany (NY):
Delmar Publishers; 1996. p. 465–78.

8
‫العنوان ‪ :‬يجب أن يكون معبرا عن مشروع البحث وأن يكون وصفيا موجزا‬

‫خطة بحث مقدمة كجزء من مقومات الحصول على درجة الماجستير‪ /‬او‪ /‬الدكتوراه في مادة التخصص‬

‫مقدم من الطبيب‬
‫‪.....‬اسم الطالب‪......‬‬
‫بكالوريوس‪... , ...................‬سنة التخرج‪ , ...‬كلية‪ , ..............‬جامعة ‪..........‬‬
‫ماجستير ‪......‬التخصص‪... ,.........‬سنة التخرج‪ , .....‬كلية‪ , ..............‬جامعة ‪..........‬‬
‫‪...‬العمل‪.... , ...‬محل العمل‪....‬‬

‫المشرفون‬

‫د‪........................... /‬‬ ‫د‪......................../‬‬

‫مدرس‪,‬قسم‪............‬‬ ‫استاذ‪,‬قسم ‪.........‬‬

‫كلية طب االسنان ‪ ,‬بنين‪ ,‬القاهرة‬ ‫كلية طب االسنان ‪ ,‬بنين ‪ ,‬القاهرة‬

‫جامعة االزهر‬ ‫جامعة االزهر‬

‫قسم ‪.....‬التخصص‪......‬‬
‫كلية طب األسنان ‪ ,‬بنين ‪ ,‬القاهرة‬
‫جامعة األزهر‬

‫‪ 201‬م ‪143 -‬ﻫ‬

‫‪9‬‬

Common questions

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The key components of the methodology section in a research protocol include a description of the study design, which may be observational or interventional. This design can be further categorized if observational (descriptive or analytic) or experimental (controlled or non-controlled). The section should detail the study setting, target population, eligibility criteria (inclusion, exclusion, and discontinuation criteria), sample size calculation and recruitment process, interventions with techniques used, observations to be made and their frequency, and any laboratory or diagnostic procedures to be performed .

The general guidelines for submitting a research protocol at Al-Azhar University Faculty of Dental Medicine include reading well the documents 'How to submit a research protocol' and 'Format for the research protocol' available in the department before writing. The thesis supervisory committee and head of department are responsible for directing this format perfectly. The protocol writing should use 14 font size, Times New Roman font face, and 1.5 line spacing on A4 page size. Numerical dates in the Arabic cover page must be in Arabic numerals, and the introduction, aim, and methodology should not exceed 6 pages. Protocols must be submitted signed by the supervisory committee to the Vice Dean for Graduate Studies on the 3rd Thursday of the month for a 10-day review period .

The introduction of a research protocol should start with a well-documented statement of the problem that is the basis of the project, including the cause of this problem and its possible solutions. It should detail the relevance of the study and provide a brief description of the most relevant studies published on the subject to support the rationale for the study. This ensures the reader understands the context and significance of the research being proposed .

Proper data management and analysis in a research protocol require outlining how data will be managed, including coding for computer analysis, monitoring, and verification. The available computer facilities and the statistical methods to be used should be clearly described, including the software and its version. This structured approach ensures data integrity and reliability of the study findings .

Ethical considerations are crucial in a research protocol submission to protect the rights and welfare of human and animal subjects. The protocol must state that human research is approved by the ethical committee of the Faculty of Dental Medicine at Al-Azhar University and enrolled patients should sign a written consent form. For animal studies, approval is required from the institute's animal welfare committee. If such a committee doesn't exist, a statement by the principal investigator(s) must indicate compliance with the International Guiding Principles for Biomedical Research involving Animals. This ensures ethical integrity and adherence to international standards .

A research protocol's study aim should be articulated in a single sentence that is simple, specific, and stated in advance. The purpose statement should directly address the primary research question. Secondary objectives may be included to broaden the scope of the investigation but should also be clear and concise. This clarity ensures that the study remains focused and relevant, guiding the methodology and analysis effectively .

The rationale for citing references in a research protocol is to acknowledge the sources of scientific evidence and to support the study's methodology and findings. At Al-Azhar University, references should be cited in the Vancouver style, with journal titles abbreviated as per practice. For articles with more than six authors, only the first six authors should be listed followed by et al. Books and chapters should also adhere to a precise structure, listing author names, title, edition, place of publication, publisher, and year. This systematic approach facilitates academic integrity and traceability of sources .

Using an organized format for interventions and observations in a research protocol is significant because it ensures clarity and reproducibility of the methods used. The section should include detailed descriptions under meaningful subheadings, mention established methods with appropriate references, and provide detailed descriptions for new or substantially modified methods along with their limitations. Observations should include how frequently they will be conducted and, if applicable, append questionnaires used. This organization enhances understanding and application of the research methods planned .

Specifying line spacing and font choices, such as 1.5 line spacing and Times New Roman font size 14, helps ensure uniformity and readability in the documents submitted, which is crucial for peer reviewers and supervisors who scrutinize multiple protocols. This facilitates easier reading and assessment, potentially reducing visual strain and improving comprehension. Al-Azhar University likely has these specifications to maintain consistency in presentation and professionalism across departments .

The English cover page of a research protocol at Al-Azhar University needs to include the research title, candidate name, department, and supervisors. This specific information ensures that the document is properly identified and attributed, facilitating administrative processes and academic record-keeping .

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