Developing Effective Standard Operating Procedures

Developing Effective Standard Operating Procedures (SOPs) Florinna Dekovic, MT (ASCP) BB, CQA(ASQ) QA and Operations Lab Manager, Human Islet & Cellular Transplant Facility (HICTF) GMP Core University of California, San Francisco email: DekovicF@LabMed2.ucsf.edu

Presentation Objectives ,[object Object],[object Object],[object Object],[object Object],[object Object]

What is an SOP? ,[object Object],[object Object],[object Object]

In clinical research, the International Conference on Harmonisation (ICH) defines SOPs: "detailed, written instructions to achieve uniformity of the performance of a specific function".

SOP Expected or defined outcome(s )

Organizing your SOP Writing Effort ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Take your cue from within your department: ,[object Object],[object Object],[object Object],[object Object],[object Object]

Before starting your 1 st SOP …envision the BIGGER picture ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Also…. ,[object Object],[object Object],[object Object],[object Object],[object Object]

SOP authorship ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Basic Parts of an SOP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Parts of an SOP, continued: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

the HEADER ____________________________________ ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Example: √ SOP TITLE: Obtaining Informed Consent Version # 1.0 SOP NUMBER: 1.1 Page 1 of 2 Author: Anna Applegate, MS Date Reviewed: June 10, 2011 Date Implemented: June 20, 2011 Reviewed By: Pablo Rubenstein, MD University of California, San Francisco Department of Surgery 513 Parnassus Avenue San Francisco, California 94143

the TITLE _____________________________________ ,[object Object],[object Object]

Example of an SOP TITLE: ,[object Object],[object Object]

Less effective SOP TITLES: ,[object Object],[object Object]

the PURPOSE _____________________________________ ,[object Object],[object Object]

Example: ,[object Object],[object Object]

Additional example: ,[object Object],[object Object],[object Object]

the SCOPE _____________________________________ ,[object Object],[object Object]

Example: SCOPE: This SOP applies to the informed consent process for all research performed in the Department of Surgery. √

Example: SCOPE: The informed consent process that is managed in the UCSF Department of Surgery is in accordance with the CHR and 21CFR Part 312 which is the Federal Code of Regulations that governs all IND research.

the PERSONNEL RESPONSIBILITIES ____________________________________ ,[object Object],[object Object],[object Object],[object Object],[object Object]

Example: ,[object Object],[object Object],[object Object]

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SAFETY _____________________________________ ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

DEFINITIONS, ABBREVIATIONS _____________________________________ ,[object Object],[object Object],[object Object],[object Object],[object Object]

Example: ,[object Object],[object Object],[object Object],[object Object]

QUALITY CONTROLS _____________________________________ ,[object Object],[object Object],[object Object]

Example: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

MATERIAL, SUPPLIES, REAGENTS, EQUIPMENT _____________________________________ ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

FORMS and DOCUMENTATION _____________________________________ ,[object Object],[object Object]

SPECIAL NOTES _____________________________________ ,[object Object],[object Object],[object Object]

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6) After explaining the general principles of research, ask the potential subject (or legally authorized representative) if they want to hear the details about the particular research. 7) Provide ample time to the potential subject, or legally authorized representative to completely read and/or listen to the consent form being read to them and time to ask questions. 8) Fully answer all questions. 9) Acknowledge the potential subject/legal representative verbalized understanding of the research and research related procedures. √

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Now that your SOP is done, may you readily IMPLEMENT it?

Your SOP Is considered a DRAFT until it is VALIDATED and APPROVED!

Validate your SOP ,[object Object],[object Object],[object Object]

Developing Effective Standard Operating Procedures

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Developing Effective Standard Operating Procedures

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