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Standard operating procedures the blueprint of research

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.

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Standard operating procedures the blueprint of research

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

  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? • Use a template • 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 Assign identification code Apply eligibility criteria Obtain informed consent Approach the subject

  7. Process mapping – Clinical research SOP (2) • Enrollment of subjects in the study Assign identification code Apply eligibility criteria Obtain informed consent Approach the subject Check list of available codes Assess demographic criteria Type of informed consent form Prepare study materials Describe the study Assess biologic criteria Respond to questions

  8. Process mapping – internal organization SOP (1) • Making a cup of coffee (Woodin, 2004) Turn on the machine Add the coffee Add the water Ensure coffee maker is ready Serve the coffee

  9. Process mapping – internal organization SOP (2) • Making a cup of coffee (Woodin, 2004) Turn on the machine Add the coffee Add the water Ensure coffee maker is ready Serve the coffee Place filter in the basket Measure water quantity Ensure the machine is plugged in Wait until the coffee has stopped dripping Measure the coffee Place the carafe in the machine Ensure carafe is empty and clean

  10. The elements of SOPs • Headline • Purpose • Responsibilities • Definitions • Instructions/ procedures • Materials and equipment • Attachements • 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)

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

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

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

  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. Definitions Define terms and acronyms used in the SOP

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

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

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

  21. Instructions (example) • 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. Materials and equipment List all of the materials and equipment needed to complete the procedure

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

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

  25. Attachments (example) • The consent form • The Eligibility Registry

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

  27. Revision history (example)

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