Research Protocol Writing Guide
Research Protocol Writing Guide
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 .