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).