Study Task Delegation: It’s Essential
Presented by: Velma Marzinotto, BScN, RN, CCRP
Does the Principal Investigator know that their responsibility for study task delegation is crucial to the proper conduct of a clinical trial? Is the PI aware of the revisions in ICH GCP E6(R2) regarding study task delegation? The aim of this talk is to help researchers learn how to set up and complete a customized Task Delegation Log (TDL) prior to the start of a clinical trial. In addition, common errors in study task delegation and ways to correct and prevent errors will be discussed.
- The PI is responsible for ensuring all key study tasks are listed on the TDL and that there is adequate staff to conduct the study
- The PI must confirm that all training is complete and all study tasks are delegated prior to the start of task(s)
- Check, check, and double-check the TDL regularly throughout the study and keep it up-to-date
About the Presenter
Velma Marzinotto, BScN, RN, CCRP
Velma Marzinotto has been the Senior Research Compliance and Education Specialist at St. Michael’s Hospital, Toronto for the past 6 years. At St. Michael’s (now Unity Health Toronto), Velma conducts routine research quality audits of clinical trials and facilitates clinical research by providing education to researchers.
Prior to this, Velma was a Clinical Research Facilitator/ Monitor at The Hospital For Sick Children (SickKids), Toronto for 11 years. While at SickKids, Velma also worked as clinical research nurse coordinator managing clinical trials in the use of anticoagulants in children, a hematology/oncology nurse educator and a hematology/oncology staff nurse. Velma obtained her BScN from McMaster University, Hamilton. She has been a SOCRA Certified Clinical Research Professional (CCRP) since 2006. She is also the Co-Chair of Canada’s N2 (Network of Networks) Quality Committee.