Study Start-Up: Ready. Set. Go!
Presented by: Velma Marzinotto, BScN, RN, CCRP
Initiating a new trial takes a tremendous amount of effort and teamwork. This talk will outline all the steps required to launch a trial from the study site’s perspective. This talk will also discuss a practical and systematic approach to obtaining essential study documentation as per GCP prior to study start.
Specific areas covered include:
- Know your study protocol and everyone’s study role throughout the study
- Use checklists, tools and templates to help you stay on track
- Ensure good documentation practices from beginning to end
About the Presenter
Velma Marzinotto. BScN, RN, CCRP
Velma obtained her BScN from McMaster University, Hamilton, Ontario. She started her nursing career as a staff RN in general pediatrics and then specialized in hematology/oncology at The Hospital for Sick Children (SickKids) in Toronto, Ontario.
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 large international multi-center clinical 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 SickKids Clinical Research Facilitation/Auditing Program. 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 15 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 Canada’s N2 (Network of Networks) Quality Committee.