1. Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases

2. Define Standard Operating Procedures as they pertain to clinical research Review the use and necessity of Standard Operating Procedures (SOPs) Identify some similarities in SOPs that cross a variety of research areas

3. Set of instructions that define or standardize a procedure or function Method to drive performance and improve results Sets the standard for quality and the level of practice that is accepted and expected Considered to be the foundation of a high quality research system

4. Define Standard Operating Procedures as they pertain to clinical research Review the use and necessity of Standard Operating Procedures (SOPs) Identify some similarities in SOPs that cross a variety of research areas

5. Not specifically mentioned in the FDA regulations Guidance and regulations infer responsibilities and SOPs can assist with this formalization 21 CFR 312.53 mandates that the investigator will “ensure that all associates, colleagues, and employers assisting in the conduct of the study are informed of their obligations….” Written SOPs put this information in writing so training and accountability can be performed and established

6. SOPs mentioned throughout the ICH GCP Guidelines ICH GCP 2.13 states that “systems with procedures that assure the quality of every aspect of the trial should be implemented”.

7. Ensures that all research conducted Follows federal regulations Adheres with ICH GCP Supports institutional policies Protects the rights and welfare of human subjects Improves quality of data Serves as an individual guide for the research site Provides basis for training Enables an objective evaluative method for all those involved in research

8. Define Standard Operating Procedures as they pertain to clinical research Review the use and necessity of Standard Operating Procedures (SOPs) Identify some similarities in SOPs that cross a variety of research areas

9. Description of the procedure(s) Background information and definitions Determination of specific components needed to perform the procedure(s) and/or task(s) Personnel, equipment, supplies, information, patient population Quality and performance review Administrative information such as effective date, review dates, expiration dates Must be in writing and readily accessible by all whose performance is related to the research

10. Unit LevelOperational LevelInstitutional Level

11. University’s approach for performance of research Regulatory overview External relationships Financial considerations and operations

12. Roles and responsibilities within a particular areas of the University Supporting infrastructure for Unit Level research activities Accountability to the Institutional Level and support for the Unit Level

13. Specific for the unit activities Granular enough to guide personnel activities Specific and without ambiguity Usable for training (must be actionable)

14. Start with gap analysis—what is present, what is needed No need to rewrite or write SOPs for activities outside your areas of responsibility Various formats Write like a policy including the who, what, when, how and why components Succinct Pilot testing before final release