Calling All Investigators! Putting ICH-GCP E6 (R2) into Practice
Presented by: Velma Marzinotto, BScN, RN, CCRP
In the demanding world of clinical research, it is imperative that Investigators know and follow the rules in order to conduct a research study successfully. It’s the PI who can make or break a trial. The aim of this talk is to help Investigators learn how to fulfill their responsibilities by putting GCP(R2) into practice. Research Coordinators will discover secrets to keeping Investigators on track throughout the study.
Webinar take-aways include:
- The PI is responsible for ensuring that the study is conducted according to the approved protocol, SOPs, GCP(R2) and all applicable regulations.
- The PI must ensure that the documentation of medical oversight is done in a timely manner i.e., sign and date!
- The PI is responsible for ensuring that all study data is accurate, complete and verifiable.
About the Presenters
Velma Marzinotto, BScN, RN, CCRP
Velma obtained her BScN from McMaster University, Hamilton, Ontario. She started her nursing career in general pediatrics and then specialized in hematology/oncology at The Hospital for Sick Children (SickKids) in Toronto.
Velma also spent two years as a Nurse Educator in hematology/oncology. Following this, Velma helped to establish the first inpatient/outpatient program in pediatric thrombophilia at SickKids. She then became a Clinical Research Nurse Manager, coordinating international multi-site trials in the use of anticoagulants for the pediatric population.
Velma has co-authored numerous publications in the field of pediatric thrombophilia and she has presented at many national and international conferences. In 2002, she helped to establish the first Clinical Research Facilitation/Auditing Program at SickKids. Velma moved to St. Michael’s Hospital, Toronto, in 2013 to develop a risk-based clinical research auditing program.
As the Senior Research Compliance and Education Specialist at St. Michael’s, she conducts routine research quality audits of clinical studies and facilitates clinical research by providing education to researchers. Velma now has over 16 years of experience as a clinical research auditor.
She has been a SOCRA Certified Clinical Research Professional (CCRP) since 2006. She is also a member of ACRP and Co-Chair of Canada’s N2 (Network of Networks) Quality Committee.