Research protocol preparation

Steps
 Title
 Background
 Trial Objective and purpose
 Trial design
 Selection and withdrawal of subjects
 Assessment of safety and efficacy
 Statistics
 Quality assurance
 Ethics
 Data handling and record keeping
 Publication policy
 References
 Appendices

1. Project title:
 Descriptive, concise
 Scientifically sound, clear, detailed

2. Background:
 Introduction to research paper
 Answers WHY and WHAT
 Description of most relevant studies published
on the subject and support the rationale of the
study
3. Research question and objectives:
 PICOT
 Population
Intervention
Comparison
Outcome
Time
4. Objectives:
 Simple, specific, stated in advance
 SMART –
specific,measurable,attainable,realistic, time
bound
 Primary objective – based on one research
question
 Secondary objective- two or three, dependant
or independent of the primary objective
5. Methodology:
 Study design
o Single most important decision to
make
o Descriptive, analytical, experimental,
operational or combination

Non comparative
Comparative design – 1. cross over
2. Parallel
Bias – selection bias
Observer bias

Randomisation
Blinding
  Inclusion and exclusion criteria
o Selection of research setting
o Define the study population
o Sampling
o Uses of Cases and controls
o Criteria should be well defined and
verifiable

 Process of collection of data

o Plans, procedures, methods
described in detail
o Observation and sample collection
done in standard manner
 Study duration
o Length of the study period and follow up
period
 Sample size calculation
Describe the study population and
justification of sample size

6. Data management and analysis

o Data collection
o Data management
o Data retention
7. Ethical consideration
o Principles to provide guidance to
physician and participants
 o Informed consent with purpose,
procedure, risk, benefits, alternative
treatment, confidentiality, finance,
additional information and signature

8. References
o References on the subject
o Books, journals, computer based
literature
9. Budget
o Patient care costs
o Travel
o Data processing
o Communication
o Secretarial expenses
o Publication
10. Appendices