3. Introduction
• Research-Research is a systematic process of
collection, analysis and interpretation of data for
generating new knowledge or to answer certain
questions.
1)Interventional studies (experiments)
2)Non-interventional surveys of naturally occuring
phenomena (descriptive & analytic studies)
3
4. Definition
A protocol for a clinical trial is a study plan
designed to describe objectives, background,
methodology, organisation, participants,
interventional procedures & assessment tools of
the trial
4
6. Format of a Protocol
1. Project title
2. Project summary
3. Trial objective & purpose
4. Trial design
5. Selection & withdrawal of subjects
6. Medicine & dosage
7. Assessment of safety & efficacy
8. Statistics
9. Quality control & quality assurance
10.Ethics
11.Data handling & record keeping
12. Publication policy
13.References
14.Appendices
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7. Format Description
Title page
-Title
-Purpose
-Name, role & contact details
-Protocol details
Signature page
-Descriptive & concise
-May need to be revised-Completion of protocol
writing
Project summary - Concise, should summarize all the elements of the
protocol.
Trial objective & purpose -Simple, specific, stated in advance
-Primary objective, secondary objective
Trial design -Study & design: Description & justification
-Bias
-Randomisation, blinding
-Primary end points & secondary endpoints
-Phases of clinical trials
-Study population
-Sample size & sampling
-Study duration 7
9. Format Description
Project title
-Title page
-Descriptive & concise
-May need to be revised-Completion of protocol writing
Project summary - Concise, should summarize all the elements of the protocol.
Trial objective &
purpose
-Simple, specific, stated in advance
-Primary objective, secondary objective
Trial design -Study & design: Description & justification
-Bias
-Randomisation, blinding
-Primary end points & secondary endpoints
-Phases of clinical trials
-Study population
-Sample size & sampling
-Study duration 9
10. Format Description
Selection &
withdrawal of
subjects
-Inclusion criteria, exclusion criteria
-Withdrawal criteria
Medicine & dosage -Describe study treatment & related details
-Medication permitted/not permitted
Assessment of
efficacy
-Specific efficacy parameters
Assessment of
safety
-Specific safety parameters
-Procedures for eliciting reports
-Procedures for reporting adverse events
& inter-current illnesses
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11. Format Description
Statistics -Description of statistical methods
-Number of subjects planned to be enrolled
-Criteria for termination of the trial
-Selection of subjects to be included
Direct access to
source/document
-Permit trial related monitoring, audits, IRB/IEC review
& regulatory inspections
Quality control & quality
assurance
Description of the methods
11
12. Format Description
ETHICS
Ethical consideration -2 components
-Research involving experiments on animals
Approval by ethics
review committee
-Studies in humans
-Studies in animals
Informed decision
making
-Appropriate
-Subject’s mother tongue
-Consent form-2 parts
Ethical checklist -The protocol must describe the measures that will be
undertaken to ensure that the proposed research is
carried out in accordance with the World Medical
Association Declaration of Helsinki on Ethical Principles
for Medical Research Involving Human Subjects
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13. Format Description
Gender issues "Ensure, where indicated, that clinical trials of
pharmaceuticals, medical devices and other medical
products include women with their full knowledge and
consent and ensure that the resulting data is analysed
for sex and gender differences."
Data handling and
record keeping
-Describe procedures for data collection and recording
-Detail methods implemented to ensure validity and
quality of data
-Confidentiality
-How long and where will the data from the study be
kept and who will be responsible for its safe keeping
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14. Format Description
Budget - Should be itemized and each item should be justified.
-Budget justification
Publication
policy
-If not addressed in a separate agreement
References -A numbered list of recent references matching those cited in
the text is needed
-The Vancouver style is preferred in biomedical research.
Appendices -Including (where relevant)
-Patient information sheet
-Patient consent form
-Data collection forms (case report form- CRF).
-Summary of product (test, procedure characteristics)
14
15. References
• Maiti R: Post Graduate topics in pharmacology
• Mahmoud F. Fathalla. WHO Regional
Publications Eastern Mediterranean Series 30,
A Practical Guide for Health Researchers, 2004
• Ahmed M.A. A Guide for writing a protocol for
a clinical trial. Sudanese Journal of Public
Health.April 2010. Vol 5. No.2
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