In the world of clinical research, it would be difficult to find someone who hasn’t heard of Standard Operating Procedures (SOPs). Yet there remains great mystery in how to create an SOP.
SOPs require a lot of explanation: What are the basics? How many are enough? How many are too many? Who creates them? Who monitors them? How do we train them? How often do we train them? How do we document that training? Where should SOPs live? Should they be controlled documents, or is a Note to File sufficient? All of these questions leave many of us overwhelmed and wondering what to do.
So we procrastinate, we ignore, and we find other projects that are much more rewarding. But the SOP can be a very powerful tool. To begin, all it takes is understanding the purpose of the SOP. From there we can write it, train it, follow it, and update it regularly. When done well, we will have robust SOPs that will serve us for a very long time. However, many fall short of fulfilling the directives they should provide. As a result, we hear chatter within the industry that we really don’t need SOPs or that too many SOPs kill productivity. But both the FDA and Office of Human Research Protections (OHRP) have published expectations of what they should find during an inspection.
This hands-on workshop will de-mystify writing Standard Operating Procedures, and will focus on how to create a well written SOP that will provide continuous support and value to its users. Participants will be provided with guidelines and templates that ensure that new and updated SOPs are uniform and user friendly.
- Define a Standard Operating Procedure
- Examine FDA Warning Letters to recognize the expectations of SOPs
- Review and discuss recent case histories for documentation and implementation issues
- Distinguish how to conduct an assessment of your SOP needs
- Review the elements of a well written SOP
- Design an SOP from the templates provided
- Describe SOP maintenance practices
- SOP Authors/Reviewers
- Quality Assurance Auditors
- Clinical Monitors
- Site Managers
- Line Functions Heads
- Project Managers
- Research Practice Administrators
- Study Coordinators
Jackie Stader, C.O.T., C.C.R.C.
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Day One: 9:00 a.m. – 4:00 p.m. Eastern (Lunch Break will run from approximately 12:00 - 1:00 p.m.)
- SOP Definitions and Standards
- SOP Needs Assessment
- Elements of an SOP
- SOP Development
- SOP Index
- Definitions of industry SOP standards
- Review case scenarios: FDA Warning Letters with interactions of SOP options that could have prevented the Warning Letter
- Using tools to help conduct an assessment of needed SOPs
- Review each element of a well-written SOP including the modification log, purpose, scope, responsibilities, and general procedures
- Applied practice skills with hands-on creation of an SOP
- Creating the SOP index
- How to document SOP training: Best practices,who and how often
- How to maintain the SOP
$800 by Early Bird Deadline noted in Upcoming Courses section above
$1,000 after Early Bird Deadline
This course is for individual registrants only and does not allow for group training. All participants are eligible for "Certificates of Attendance," and accreditation, provided that accreditation requirements are met.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 6 hours (0.6 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-14-048-L01-P. Released: 2/14.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.