To understand how to identify, document, report, and resolve Protocol Deviations.
•    To appreciate research site responsibilities and requirements regarding deviations.
•    To be prepared to apply skills to develop plans to augment compliance for current and future studies.

Protocol Deviations: What You Need to Know

•    Title: Essential Documents, SAE Reporting, PI and Study Staff Considerations for QA/Monitoring Visits
•    Presenter: Jill Kessler MS, MSL, CCRP

•    Learning Objectives
1.    Essential document review and importance during life of study
2.    Preparing for a successful remote site visit
3.    Common findings during IMVs and how to prevent or resolve
4.    FDA 483 review/case study. 

BIO: Jill Kessler MS, MSL, CCRP
I was fortunate to start my research career at Johns Hopkins in oncology as a research coordinator. After working alongside surgeons, oncologists and nurses, I found their passion for patient care is truly admirable and contagious. To strengthen my interests in research and compliance, I attended the Maryland Carey School of Law and obtained a Master of Science in Health Law. As I was completing this degree, I gained more knowledge of the intersection of research and the legal system. This additional focus on health law has been instrumental in my career. 
I have worked in Quality Assurance for the past 10 years. There is always a new safety situation to be reported which must be put through rigorous reviews to ensure the data is reflective of this information for future publications. After 12 years in research, I still learn something new daily.
I am currently a Sr. Clinical Trial Monitor for the Transplant Oncology Infectious Disease Department at Johns Hopkins University. My focus is monitoring data for several HIV Organ Policy Equity (HOPE) Act studies - which allow for research to transplant organs from HIV-positive donors into HIV-positive recipients.