Writing Site Specific Standard Operating Procedures (SOPs)
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1 2009 Web Seminar Series Writing Site Specific Standard Operating Procedures (SOPs) Instructors: Caroline Baron-Myak, R.N., B.S.N. Mary Elyse Kaye, R.N., B.S.N. 1
2 Introduction This is a one-hour seminar providing a process, tools and guidelines for writing site-specific SOPs that facilitate process documentation and consistency An investment in your sanity 2 2
3 Training Outline Topic 1: SOP value and purpose Topic 2: Recommended sections and content guidelines Topic 3: Protocol and site specific process breakdown Topic 4: Process risk identification and mitigation 3 3
4 Site Specific Standard Operating Procedures A document for service of care Every protocol has a manual of operations Every site develops site specific SOPs Institutional Standards IRB Standards 4 4
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6 In Simple Terms Prepare a step-by-step guide Someone could step in for you Guide to keep study processes going KISS (Keep it simple sweetheart) Enable someone to walk right in the door and be able to do the work by following your SOP. 6 6
7 Standardizing procedures Training new staff members Process standardization Facilitates quality Manage work processes Minimizes miscommunication Identify vulnerable components Present opportunity to protect SOP Value and Purpose 7 7
8 Recommended Sections and Content Guidelines Cover Page Table of Contents Core Sections Introduction Purpose Scope Definitions/Abbreviations References Process Detail Description Write in a concise, step-by-step, easy-to-read- format SOPs should be written with sufficient detail so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised. 8 8
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11 Protocol and Site Specific Process Breakdown Gather tools and paperwork needed for operation Routine events Urine screens Risk events Suicidal thoughts Watch operation being performed Role-play and brainstorm for content Brings things to light Consider timing each task Record the operation sequentially Direct observation is best Flow Process Charts 11 11
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13 Process Risk Identification and Mitigation Risk Management Process Risk identification Identify project, product and risks level Risk Assessment/Analysis Assess likelihood and consequences Risk Planning Develop plans to avoid or minimise risk impact Risk Monitoring/Controlling Monitor and adjust plans Risk Identification Brainstorm to identify potential problems Risk Assessment Assess risk Severity Likelihood Controllability Risk Response Development Plan to reduce possible damage Make contingency plans Risk Monitor/Control Implement risk strategy Monitor and adjust Change management 13 13
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15 Revealing & Planning for Vulnerable Operations Generate list of possible risks Goal = Find potential problems before they happen Break into task areas Brainstorm Past experience Focus on events that could create unwanted outcome 15 15
16 Revealing & Planning for Vulnerable Operations Events Outcomes Mitigation Trigger Responsible Person Participant couldn t provide Urine Sample Missed labs Have drink available Prompt for sample collection Conversation greeter Participant missed study window Missed data Schedule earliest day possible Reminder calls No show RA/RC Snow storm Clinic closed transportation Reschedule Weather report RA/RC Suicidal thought Patient safety risk Doctor for safety assessment / referral Conversation RA/RC/MD 16 16
17 SOPs 17
18 Handouts & Resources Handouts SOP template Flowchart template Resources online Guidance for Preparing Standard Operating Procedures Process mapping A Guide for Health Service Staff
19 Upcoming Webinar This concludes our presentation today. Thank you for joining. Ethical Principles in Clinical Research 11/19/09 Send Registration Requests to 19 19
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22 National Drug Abuse Treatment Clinical Trials Network Dissemination Library A copy of this presentation will be available electronically after the meeting from: CTN Dissemination Library and NIDA Livelink 22
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