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Research Protocol

This document outlines the key steps and considerations for developing a research protocol, including establishing a descriptive title, providing relevant background information and literature review, clearly defining the research objectives and questions, describing the study design and methodology for participant selection, data collection and analysis, addressing ethical concerns, and planning for data management and publication/dissemination of results. Some of the important aspects that are highlighted include developing specific and measurable objectives, describing inclusion/exclusion criteria and the sampling methodology, explaining how randomization and blinding will be implemented if applicable, and obtaining informed consent from participants.

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3K views4 pages

Research Protocol

This document outlines the key steps and considerations for developing a research protocol, including establishing a descriptive title, providing relevant background information and literature review, clearly defining the research objectives and questions, describing the study design and methodology for participant selection, data collection and analysis, addressing ethical concerns, and planning for data management and publication/dissemination of results. Some of the important aspects that are highlighted include developing specific and measurable objectives, describing inclusion/exclusion criteria and the sampling methodology, explaining how randomization and blinding will be implemented if applicable, and obtaining informed consent from participants.

Uploaded by

api-228136529
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
  • Research Protocol Preparation

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

Research protocol preparation Steps Title Background Trial Objective and purpose Trial design Selection and withdrawal
Population Intervention Comparison Outcome Time 4. Objectives: Simple, specific, stated in advance SMART – specif
Inclusion and exclusion criteria o Selection of research setting o Define the study population o Sampling o Uses of Cases an
o Informed consent with purpose, procedure, risk, benefits, alternative treatment, confidentiality, finance, additional in

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