A summary of the scheme of biomedical research.

1. Health Research
Overview of the General Scheme
of
Ahmed Negida
Fifthyearmedical Student,MBBCh candidate
FacultyofMedicine, ZagazigUniversity,Egypt

2. 1. Developing a research idea
Clinical
Practice
Reading
Literature

3. 2. Searching the literature
Textbooks
Electronic
databases
Conference
proceedings

4. 3. Formulating the hypothesis
• Alternative hypothesis (H1)
The hypothesis which the research is trying to prove.
• Null hypothesis (H0)
The hypothesis which the researcher is trying to disprove.

5. The drugs X is effectiveThe drugs X is not effective
In a clinical trial to test the efficacy of drug (X) for the treatment of obesity, what
are the null and alternative hypotheses?

6. 4. Planning phase (protocol writing)
Which data can answer
my research question?
Which research design is
suitable for my situation?
Source of data? How can
we collect these data?
How will we analyze
these data?

7. Research protocol
 Systematic description of your research study
 Must meet regulatory requirements to justify research and
protecting research participants
 Reviewed and approved by Ethics committee
Research proposal
 Statement of work (statement of purpose)
 Must meet the requirements of the funding agency
 Reviewed and approved by funding agency

8. Importance of research protocol
 Planning is the most important step in research
 Applying for ethical approval
 Applying for funding (using a proposal)
 International registration of research studies
 PROSPRO for systematic review
 Clinicaltrials.gov for clinical studies

9. 10.Discontinuation of the Study
11.Statistics
12.Quality Control and Assurance
13.Ethics
14.Data handling and Recordkeeping
15.Publication Policy
16.Project Timetable/Flowchart
17.References
18.Supplements/Appendices
1. Title Page (General Information)
2. Background Information
3. Objectives/Purpose
4. Study Design
5. Selection and Exclusion of Subjects
6. Treatment of Subjects
7. Assessment of Efficacy
8. Assessment of Safety
9. Adverse Events
Components of research protocol

10. 5. Pilot study
What?
How?
Why?

11. 6. Gaining Ethical approval
Any research involving human subjects must be approved by
appropriate ethics reviewers
IRB (institutional review board)
Ethics committee
Why?

12. 7. Study implementation
Screening
Subjects’ enrollment
Data Collection
Data Entry
Implementing the intervention

13. 8. Data analysis

14. 9. Writing the report (manuscript)

15. 10. Publishing your work