the Standard operating procedures presentation_Cluj

Report
Oana M. Pop MA
Cluj School of Public Health
College of Political, Administrative and Communication Sciences
Babes-Bolyai University
Standard operating procedures
the blueprint of research
Cluj-Napoca, Romania
2014 June 17th
Standard operating procedures SOPs
A set of written, detailed instructions or
steps needed to perform a specific task the
same way each time it is completed
WHEN do we use them?
Every step of the research process
Internal organization rules
WHY do we use them?
Identify the person(s) responsible for a
specific task
Describe the steps needed to complete
specific actions
Train (new)staff/ interns
Guideline for conducting research
Human protection
Data quality
How to write SOPs?
1) Use a template
2) Identify the purpose/ aim of the SOP
3) Use process mapping (determine each
step of the task and try to make it easier to
follow)
4) Convert the map into rules
5) Test the SOP
Process mapping – Clinical
research SOP (1)
• Enrollment of subjects in the study
Approach the
subject
Apply
eligibility
criteria
Obtain
informed
consent
Assign
identification
code
Process mapping – Clinical
research SOP (2)
• Enrollment of subjects in the study
Approach the
subject
Apply
eligibility
criteria
Obtain
informed
consent
Assign
identification
code
Prepare
study
materials
Assess
demographic
criteria
Type of
informed
consent form
Check list of
available
codes
Describe the
study
Assess
biologic
criteria
Respond to
questions
Process mapping – internal
organization SOP (1)
• Making a cup of coffee (Woodin, 2004)
Ensure coffee
maker is
ready
Add the
coffee
Add the
water
Turn on the
machine
Serve the
coffee
Process mapping – internal
organization SOP (2)
• Making a cup of coffee (Woodin, 2004)
Ensure coffee
maker is
ready
Add the
coffee
Add the
water
Ensure the
machine is
plugged in
Place filter in
the basket
Measure
water
quantity
Ensure carafe
is empty and
clean
Measure the
coffee
Place the
carafe in the
machine
Turn on the
machine
Serve the
coffee
Wait until the
coffee has
stopped
dripping
The elements of SOPs
1)
2)
3)
4)
5)
6)
7)
8)
Headline
Purpose
Responsibilities
Definitions
Instructions/ procedures
Materials and equipment
Attachements
Revision history
Headline
It needs to contain the
name of the author, the
number of the SOP, issued
date, effective date, last
updated date, approval
Standard Operating Procedure
SOP on how to write a
Standard Operating
Procedure
Author
POM
SOP #
1
Revision #
1.0
Issued date
17.06.2014
Effective Date 20.06.2014
Last Updated 17.06.2014
Page 1 of # 2
Approval
PI
Header (example)
Purpose
Write down to goal/ aim of
the SOP
Purpose (example)
The aim of this SOP is to describe the
process of subjects’ enrollment in the study
Responsibilities
State the person (avoid using
names; use titles instead)
responsible to comply with the
SOP and the person
responsible for training the
personnel
Responsibilities (example)
Data collectors are responsible for applying
this SOP when enrolling subjects in the
study. The research assistant will train data
collectors in the rules of the SOP.
Definitions
Define terms and acronyms
used in the SOP
Definitions (example)
IC = Informed consent
BQ-W = Baseline questionnaire for women
BQ-M = Baseline questionnaire for men
Instructions/
procedures
Use process mapping to break
down the task into steps and
further detail the steps. Use
clear and concise language.
Instructions (example)
Subjects’ enrollment in the study
Approach the
subject
Prepare
study
materials
Describe the
study
Instructions (example)
1. Approach the subject
1.1. The data collector should have a study
description, two informed consents, one BQW questionnaire and the Eligibility Registry
on him, before approaching the subject.
1.2. The data collector should approach the
subject and describe the study to him, if the
subject is interested to participate.
Materials and
equipment
List all of the materials and
equipment needed to
complete the procedure
Materials (example)
The MicroCO device is needed to assess the
biological eligibility criterion
Attachments
List applicable forms that are
required to be completed in
the SOP
Attachments (example)
1. The consent form
2. The Eligibility Registry
Revision history
History of the revisions made
on the SOP
Revision history (example)
Revision History
Revision
1.0
…
…
Date
17.06.2014
Author
POM
Change
reference
All pages
Reason for change
Template
development
1. Purpose
Write down the goal
of the SOP (why the
SOP is being written).
Mention the
objective(s) the SOP
is intended to achieve
2. Responsibilities
State the personnel,
departments or
groups responsible
for both performing
and complying with
the SOP. State the
person responsible
for assuring the
appropriate
personnel are trained
in the SOP.
3. Definitions
Define terms and
acronyms that people
reading the SOP
would require
clarification on.
4. Instructions/
Procedures
Instructions are developed
based on the process mapping
and should be specified in a
clear and concise language.
Avoid using passive voice and
names (use titles instead).
Specify order in which
activities are done. If an SOP
comprises a long list of steps,
break down the steps into
logical sections of about 7-10
steps per section. Flowcharts/
diagrams and references to
other associated SOPs can
also be inserted.
5. Materials and
Equipment
List all of the
materials and
equipment needed to
complete the
procedure.
6. Attachments
List applicable forms
that are required to
be completed in the
SOP (such as
informed consent
forms of
questionnaires).

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