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Standard operating proceduresthe blueprint of research
Cluj-Napoca, Romania2014 June 17th
Oana M. Pop MACluj School of Public Health
College of Political, Administrative and Communication SciencesBabes-Bolyai University
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
WHY do we use them?
Identify the person(s) responsible for a specific taskDescribe the steps needed to complete specific actions Train (new)staff/ internsGuideline for conducting research Human protectionData quality
How to write SOPs?
1) Use a template2) Identify the purpose/ aim of the SOP3) Use process mapping (determine each step of the task and try to make it easier to follow)4) Convert the map into rules5) 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
Describe the study
Type of informed consent form
Respond to questions
Check list of available codes
Assess biologic criteria
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
Turn on the machine
Serve the coffee
Ensure the machine is plugged in
Ensure carafe is empty and clean
Place filter in the basket
Measure the coffee
Measure water quantity
Place the carafe in the machine
Wait until the coffee has stopped dripping
The elements of SOPs
1) Headline2) Purpose3) Responsibilities4) Definitions5) Instructions/ procedures6) Materials and equipment7) Attachements8) Revision history
It needs to contain the name of the author, the number of the SOP, issued date, effective date, last updated date, approval
Headline
Header (example)
Standard Operating Procedure Author POM
SOP on how to write a Standard Operating Procedure
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
Purpose (example)
The aim of this SOP is to describe the process of subjects’ enrollment in the study
State the person (avoid using names; use titles instead) responsible to comply with the SOP and the person responsible for training the personnel
Responsibilities
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 (example)
IC = Informed consentBQ-W = Baseline questionnaire for womenBQ-M = Baseline questionnaire for men
Use process mapping to break down the task into steps and further detail the steps. Use clear and concise language.
Instructions/ procedures
Subjects’ enrollment in the study
Approach the subject
Prepare study materials
Describe the study
Instructions (example)
Instructions (example)
1. Approach the subject1.1. 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.
Revision history (example)
Revision History
Revision Date AuthorChange reference Reason for change
1.0 17.06.2014 POM All pages Template development
… …
1. PurposeWrite down the goal of the SOP (why the SOP is being written). Mention the objective(s) the SOP is intended to achieve
2. ResponsibilitiesState 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.
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.