How to write a protocol?

Dr. Anirban Hom Choudhuri (MD, FICCM, PGDMLE, FIAMLE)

Professor (Critical Care)
GIPMER, New Delhi
 Clinical research follows an action plan

Clear pathways must be existent & should be demonstrable

Must be approved and monitored by the IRB/IEC upon its

satisfaction that-
 The project is worth undertaking for scientific gains
 Investigator(s) have the necessary competence and work experience
 No scope for ethical violations & infringements of participants’ rights
 Requirements & limitations are adequately explained

All of these are documented in Research protocol

After the study is launched, the protocol cannot not

be altered during its course
 What purpose does it serve?

Raises the research question and clarifies its importance

Serves as guide through the research

Forces time and budget estimates

More proper is the draft, more likelihood are chances of

scientifically sound conclusions being drawn
 Components of the protocol

Title Methodology: Study design,

Administrative details
Project summary
study population and methods of
recruitment, variables list, sample
size, methods of data collection,
data collection tools, plan of
analysis (analysis of data)

Introduction Project management: Work

plan (Timeline - proposed
schedule)
Preliminary studies
Strengths and limitations
Study objectives
Prior approvals, if any

Biodata/CV
 Title

Should carry maximum information in few words

Good to keep within 12-15 words

What is the study about, who are the targets, what is the
setting
Epidemiology and characteristics of VAP in Indian ICUs

Etiology, prevalence & course of VAP in Indian ICUs

Etiology, prevalence, clinical profile and outcome of VAP

in Indian ICUs
 Administrative Details

Contents page - list of relevant sections and sub-sections with

corresponding page number

Signature page - signed by members of the research team and dated

to confirm that the version concerned has been approved by them

Contact details- for the PI listing postal, e-mail addresses and

telephone numbers
 Project Summary

Distinctive and concise

Should sum up all the essentials of the protocol

Should stand on its own

 Introduction (Background)
Should answer the importance of the topic, the gaps in the
literature, the purpose of the study and possible benefits
for the society from the study

The research question should be addressed concisely

The problem should be clearly recognizable to the reader

Positives, negatives and limitations of the earlier studies

 Aims & Objectives

Aims- broad statements of desired outcomes, or the general

intentions of the research

Objectives are subsidiary to aims

Should be (SMART objective): Specific, Measurable,

Achievable, Relevant and Time based

Should not have too many aims and only include objectives
consistent with the aims

Should be stated in action verbs that illustrate their purpose:

i.e., “to determine, to compare, to verify, to calculate, to
reduce, to describe, etc.”
 Generation of hypothesis

Statement based on scientific theory that recognizes the

predicted correlation between two or more variables

Transforms research questions into a statement that predicts

an expected outcome

Null hypothesis: a statement that there is no actual

relationship between variables (H0 or HN)

Alternative hypothesis: a statement that suggests a potential

outcome that the researcher may expect (H1 or HA)
Is there a difference in BNP levels between
heart failure with low EF and normal EF?
Null Hypothesis: There is no difference in BNP levels between heart failure with
low EF and normal EF

Alternate Hypothesis: There is difference in BNP levels between heart failure

with low EF and normal EF

The final conclusion of research will either accpet a null

hypothesis or reject it in favour of an alternative
hypothesis
Practically all hypotheses are stated in the null form,
because they have their inferential statistics

Aims should be logically linked and arranged

according to the tested hypothesis
 Materials & methods

Should describe in detail - ‘Who’, ‘Where’ and ‘How’ will

conduct the research

Divided into various subheadings

Study design
Study population
Sample size (if calculated)
Proposed intervention, if any
Data collection methods & instruments
 Study design
Proper explanation as to why a particular design is chosen

Ethics, logistic concerns, and scientific thoroughness

Object Common design

Prevalence Cross sectional

Incidence Cohort

Cause (in order of reliability) Cohort, case control, cross sectional

Prognosis Cohort

Treatment effect Controlled trial

 Study population (Study subjects)

Definition for eligibility, inclusion, exclusion & discontinuation

In clinical trials, allocation of subjects to study arms

Concealment and randomization process, if applicable

 Sample & sampling techniques

Sample size calculation is recommended for both economical

and ethical reasons

Power of the study

Sampling technique

Steps involved in the recruitment of subjects should be

described according to the selection criteria

“Informed consent”
 Proposed intervention

When using drugs, both pharmacological and brand name

should be mentioned followed by the name of the
manufacturing company and country. Drug route, dosage,
frequency of administration, and total duration of treatment
with the drug should be mentioned

When using apparatus its name should be given followed by

the name of the manufacturer and country

Who will be responsible for the interventions?

What activities each personnel will perform and with what

frequency and intensity?
 Data collection methods & instruments

Retrospective data (medical records)

Questionnaires

Interviews (Structured, Semi-Structured)

Laboratory test (literature or personal knowledge should be
referenced, if established test, or description should be provided in details, if
not established)

Clinical examinations

Description of instruments, tools used for data collection, as well as

the methods used to test the validity and reliability of the instrument should be
provided
 Data Management and Analysis Plan

The analysis plan and statistical tests that will be used to

answer the research question, with appropriate references

Chosen variables and their appropriate tests

For computer programs, their software versions

Good to write after seeking advice from a statistician

 Project Management

Outline of activities of all the phases of the research to be carried

out according to an anticipated time schedule (‘Work plan’)

Proper time table for accomplishing each major step

 Operational Planning and Budgeting

Head wise expenditure for the study-manpower,

transportation, instruments, laboratory tests, drugs etc.

Budget estimate as attached annexure

Costs including personnel, consumables, equipment,

supplies, communication, and funds for patients and data
processing

Justification
 Annexure
Informed consent form (English, Hindi, vernacular)

Patient information sheet

Approval letters from departmental committees, other scientific

committees etc.

Photocopy of questionnaire , study instruments (if any)

Case Record Forms (CRFs)

Budget details & COI (if any)

CV of the investigators
 Common Pitfalls to Avoid

Insufficient information about recent studies and improper

explanation of the problem

Underpowered sample size

Invalid or unreliable instrument

Improper statistics
 Conclusion

Short yet comprehensive to clearly summarize the project

Language must be clear, free of typographical errors, accurate

and easy to read

Extra time spent to write a good protocol can save time at a

later stage

Not always easy!