Protocol is an established
code of procedures.
A protocol defines a set of operational procedures to ensure
that there is a well- defined way of doing a particular task or range of tasks
(often informed by past experience). Protocol is a “road map” for
the research project/work.
It is a predefined written procedural method in
the design and implementation of experiments.
It is an exploratory document with a defined plan and shall clearly spells out
why you are doing the research, what the research question and data needed to
answer the question are, and how to gather and analyze the data.
In most cases it is a formal agreement and
commitment between two or more parties on a common response to specified
issues, events or circumstances e.g. information sharing.
Protocol should stand on its own,
and refrain from referring to multiple documents for execution of the
activity. Protocols are written whenever it is
desirable to standardize a laboratory method to ensure successful replication (reproducibility) of results
by others in the same laboratory or by other laboratories. Detailed protocols
also facilitate the assessment of results through peer
review. Protocols are employed in a wide range of experimental
fields.
The central elements of
protocol include:
·
Study rationale
with background
·
Study objective(s)
·
Study Design
(organization of experiment) and methodology
·
Required equipment
and instruments
·
Safety precautions
·
Detailed
procedures/methods
·
Study
population/samples
·
Study time frame
(Duration)
·
Calculation of
results and reporting standards
·
Statistical
considerations
·
Rules for
predefining and documenting excluded data to avoid bias.
·
Accepted
outcome/acceptance criteria
Protocol differ
from SOP in being more elaborate; provide background & rationale
for exploratory study with objectives and at times acts as an agreement between
two or more parties/stakeholders (multi center studies). Protocol is often
employed for a one time study. On the other hand the SOP provides a
set of systematically written instructions to ensure that a task is performed
same way each time.
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