Oana M. Pop MA
Cluj School of Public Health
College of Political, Administrative and Communication Sciences
Babes-Bolyai University
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

Every step of the research process
Internal organization rules

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

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
Prepare study materials
Describe the study
Apply eligibility criteria
Assess demographic criteria
Assess biologic criteria
Obtain informed consent
Type of informed consent form
Respond to questions
Assign identification code
Check list of available codes

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
Ensure the machine is plugged in
Ensure carafe is empty and clean
Add the coffee
Add the water
Place filter in the basket
Measure the coffee
Measure water quantity
Place the carafe in the machine
Turn on the machine
Serve the coffee
Wait until the coffee has stopped dripping

1) Headline
2) Purpose
3) Responsibilities
4) Definitions
5) Instructions/ procedures
6) Materials and equipment
7) Attachements
8) Revision history

It needs to contain the name of the author, the number of the SOP, issued date, effective date, last updated date, approval

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Standard Operating Procedure
SOP on how to write a
Standard Operating
Procedure
Author POM
SOP #
Revision #
1
1.0
Issued date 17.06.2014
Effective Date 20.06.2014
Last Updated 17.06.2014
Approval PI
Header (example)

Write down to goal/ aim of the SOP

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

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

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.

Subjects’ enrollment in the study
Approach the subject
Prepare study materials
Describe the study

1. Approach the subject
1.1. The data collector should have a study description, two informed consents, one BQ-
W 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

The MicroCO device is needed to assess the biological eligibility criterion

Attachments
List applicable forms that are required to be completed in the SOP

1. The consent form
2. The Eligibility Registry

Revision history
History of the revisions made on the SOP

Revision History
Revision Date
1.0
17.06.2014
Author
POM
…
…
Change reference Reason for change
All pages 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).