Source Documentation for Clinical Research Professionals
-
Register
- Member - Free!
- Non-member - $75
Ms. Croghan will discuss the importance of good documentation at clinical investigator sites including facts regarding regulatory inspection findings, what’s the purpose of source documentation, definitions of source data and source documents, good documentation principles.
At the completion of the webinar, participants should be able to:
What are source documents?
Common Source documents and what to address while creating source documents
How Case Report Forms (CRFs) and source documents can reduce deviations and other protocol identified gaps
Katrina A. Croghan, M.S., CCRP
Quality Management Coordinator- Research | Assistant Professor of Health Care Administration
Mayo Clinic Comprehensive Cancer Center: Cancer Clinical Trials Office
Katrina Croghan is a Quality Management Coordinator (QMC) for the Mayo Clinic Comprehensive Cancer Center (MCCCC) focusing on the enterprise Quality Management System for MCCCC; which includes the establishment, maintenance, and education of all MCCCC documentation, policies, procedure and etc. She has also been a significant contributor to multiple training and orientation opportunities within MCCCC, including a Principal Investigator (PI) Boot Camp for new investigators, the MCCCC Orientation course for new study team staff and recently implementing a continued education program for current study team staff. Katrina holds a B.S. and M.S. from State Cloud State University in St. Cloud, Minnesota and became a Certified Clinical Research Professional (CCRP) in 2014. Katrina has been with Mayo Clinic since 2012 and started her career as an Assistant Clinical Research Coordinator (ACRC) under the Department of Medicine- Clinical Research Office. She has been with the MCCCC since 2015 and has held Certified Clinical Research Coordinator (CRC), Lead CRC and Senior CRC prior to moving into the QMC role. Outside of Mayo Clinic, Katrina is the co-chair for the SOCRA Southeast MN Chapter since 2022; and has recently (2023) become an Adjunct Professor at St. Cloud State University, under the Applied Clinical Research Program.