1. Standard operating procedures the blueprint of research Cluj-Napoca, Romania 2014 June 17th Oana M. Pop MA Cluj School of Public Health College of Political, Administrative and Communication Sciences Babes-Bolyai University

2. 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

3. WHEN do we use them? Every step of the research process Internal organization rules

4. 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

5. 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

6. Process mapping – Clinical research SOP (1) Enrollment of subjects in the study Approach the subject Apply eligibility criteria Obtain informed consent Assign identification code

7. 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

8. 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

9. 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

10. The elements of SOPs 1)Headline 2)Purpose 3)Responsibilities 4)Definitions 5)Instructions/ procedures 6)Materials and equipment 7)Attachements 8)Revision history

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

12. Header (example) Standard Operating Procedure AuthorPOM SOP on how to write a Standard Operating Procedure SOP #1 Revision #1.0 Issued date17.06.2014 Effective Date20.06.2014 Last Updated17.06.2014 Page 1 of # 2ApprovalPI

13. Write down to goal/ aim of the SOP Purpose

14. Purpose (example) The aim of this SOP is to describe the process of subjects’ enrollment in the study

15. State the person (avoid using names; use titles instead) responsible to comply with the SOP and the person responsible for training the personnel Responsibilities

16. 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.

17. Define terms and acronyms used in the SOP Definitions

18. Definitions (example) IC = Informed consent BQ-W = Baseline questionnaire for women BQ-M = Baseline questionnaire for men

19. Use process mapping to break down the task into steps and further detail the steps. Use clear and concise language. Instructions/ procedures

20. Subjects’ enrollment in the study Approach the subject Prepare study materials Describe the study Instructions (example)

21. 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.

22. List all of the materials and equipment needed to complete the procedure Materials and equipment

23. Materials (example) The MicroCO device is needed to assess the biological eligibility criterion

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

25. Attachments (example) 1.The consent form 2.The Eligibility Registry

26. History of the revisions made on the SOP Revision history

27. Revision history (example) Revision History RevisionDateAuthor Change referenceReason for change 1.017.06.2014POMAll pagesTemplate development … …

28. 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

29. 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.

30. 3.Definitions Define terms and acronyms that people reading the SOP would require clarification on.

31. 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.

32. 5.Materials and Equipment List all of the materials and equipment needed to complete the procedure.

33. 6.Attachments List applicable forms that are required to be completed in the SOP (such as informed consent forms of questionnaires).