Element of Protocol For Research Studies

8/1/2019
BASIC COURSE IN BIO-MEDICAL RESEARCH

nie.gov.in
7 steps of a successful protocol

7
6 Seek ethics
committee
5 Submit to approval
peer
Prepare review
4 instruments
and annexes
3 Write
draft
protocol
2 Prepare
dummy
tables
1 Outline a
one-page
concept
Identify paper
topic,
question
and nie.gov.in
objectives
1
8/1/2019
The first draft of the protocol

• Thought as it is written • Does not exceed
• Keeps concept paper as
summary 2000 words
• Uses the concept paper • Introduction < 20% of
outline length
• Background/justification
• Objectives • Contains 5 – 10 key
• Methods references
• Expected benefits
• Budget
nie.gov.in
Outline of the methods section

Study design
Description of interventions (experimental studies)
Study population
Operational definitions
Sampling procedure
Sample size
Data collection
Analysis plan
Project implementation plan (Quality assurance)
Human subjects protection
nie.gov.in
2
8/1/2019
Study design paragraph

• Explains how the objectives lead to indicators and to
the study design
• Describes the type of study
• Experimental
• Cohort
• Case control
• Cross sectional
• Describes logistical arrangements
• Prospective
• Retrospective nie.gov.in
Description of the interventions

• Applicable if an intervention is planned
• Clinical trial
• Community intervention
• Describes the “treatment” applied to the
intervention and control group
• Who?
• What?
• When?
• How? nie.gov.in
3
8/1/2019
Study population paragraph

• Use time, place and person:
• Inclusion criteria
• Exclusion criteria
• May be added as a separate section but do not differ
conceptually from the inclusion criteria
• Do not confuse the study population and the
study sample
• Ensure that the study population is suitable to
address the objectives nie.gov.in
Operational definitions paragraph

• Spells out and justifies

• Key outcomes
• Key exposures
• Clarity and specificity essential
• References, if applicable
nie.gov.in
4
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Sampling procedure paragraph

• Describes and justifies
• The type of sample used
• Convenience sample (Avoid if possible)
• Random sample
• Systematic sample
• Cluster sample
• The way the sample will be selected in practice
• Provides references, if needed
• Explains randomization, if applicable nie.gov.in
Sample size paragraph

• Details all parameters used to estimate the

sample size
• Explains how the estimate was generated
• Software used
• Formula used
• Provides references, if needed
nie.gov.in
5
8/1/2019
Data collection paragraph

• Lists the data that will be collected
• Specifies how the data will be collected
• Who?
• How?
• Type of instrument to be used
• Type of data collection method
nie.gov.in
The analysis plan paragraph

• Data entry
• Software used
• Recoding stage
• Descriptive stage
• Prevalence, incidence
• Analytical stage
• Univariate
• Stratified
• Multivariate analysis nie.gov.in
6
8/1/2019
Project implementation plan paragraph

• Details the steps that will be used to ensure data
quality at all stages
• Addresses
• Data collection
• Data entry and analysis
• Reporting
• Roles and responsibilities of investigators
• Project governance
• Coordination of project activities
• Project timeline nie.gov.in
Human subjects protection paragraph

• Explains the steps that will be used to protect
the study participants
• Addresses
• Minimization of risks (Confidentiality)
• Maximization of benefits
• Compensations (without undue incentive)
• Informed consent
• Approval procedures (Ethics committee) nie.gov.in
7
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Data collection instruments

Interview/FGD
Questionnaire
guide
Structured
observation
guide
Abstraction
form
nie.gov.in
Annexes
Standard Training Participant

operating framework for recruitment
procedures field workers material
Adverse event Study

management Consent forms management
form forms
nie.gov.in
8
8/1/2019
Finalizing the protocol

Peer review to obtain feedback from
colleagues and experts
Review by ethics committee
Archive all drafts
nie.gov.in
nie.gov.in
9
8/1/2019
The life cycle of research

Identify data needs Inform the stakeholders
Spell out the Formulate

research question recommendations
Formulate the
Draw conclusions
study objectives
Plan the analysis Analyse data
Prepare data
Collect data
collection instruments
nie.gov.in
nie.gov.in
10

Element of Protocol For Research Studies

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Element of Protocol For Research Studies

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8/1/2019

BASIC COURSE IN BIO-MEDICAL RESEARCH

7 steps of a successful protocol

The first draft of the protocol

BASIC COURSE IN BIO-MEDICAL RESEARCH

Outline of the methods section

Study design paragraph

BASIC COURSE IN BIO-MEDICAL RESEARCH

Description of the interventions

Study population paragraph

BASIC COURSE IN BIO-MEDICAL RESEARCH

Operational definitions paragraph

• Spells out and justifies

Sampling procedure paragraph

BASIC COURSE IN BIO-MEDICAL RESEARCH

Sample size paragraph

• Details all parameters used to estimate the

Data collection paragraph

BASIC COURSE IN BIO-MEDICAL RESEARCH

The analysis plan paragraph

Project implementation plan paragraph

BASIC COURSE IN BIO-MEDICAL RESEARCH

Human subjects protection paragraph

Data collection instruments

BASIC COURSE IN BIO-MEDICAL RESEARCH

Standard Training Participant

Adverse event Study

Finalizing the protocol

BASIC COURSE IN BIO-MEDICAL RESEARCH

Review by ethics committee

Archive all drafts

BASIC COURSE IN BIO-MEDICAL RESEARCH

The life cycle of research

BASIC COURSE IN BIO-MEDICAL RESEARCH

Spell out the Formulate

Plan the analysis Analyse data

BASIC COURSE IN BIO-MEDICAL RESEARCH

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