Overview of the General Scheme
Fifthyearmedical Student,MBBCh candidate
1. Developing a research idea
2. Searching the literature
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.
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?
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
Systematic description of your research study
Must meet regulatory requirements to justify research and
protecting research participants
Reviewed and approved by Ethics committee
Statement of work (statement of purpose)
Must meet the requirements of the funding agency
Reviewed and approved by funding agency
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
10.Discontinuation of the Study
12.Quality Control and Assurance
14.Data handling and Recordkeeping
1. Title Page (General Information)
2. Background Information
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