Presented by Florinna Dekovic, MT (ASCP) BB, CQA(ASQ), Operations Lab Manager at UCSF.

1. 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

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

5. SOP Expected or defined outcome(s )

6. SOPs ISO

7. With a good procedure

8. Having a good SOP …..

9. Furthermore, SOPs…

14. Where to begin?

16. Figure out the length

20. 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

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

29. 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.

45. 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. √

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

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