PMI Feasibility Meeting
The main goal of this meeting is to walk through the first dosing visit and identify potential challenges before the actual trial visit occurs.
What is the Mock Visit?
This is defined as a temperature reading outside acceptable ranges for more than 30 minutes.
What is a temperature excursion?
This individual must be physically present at the CHCO Anschutz campus and able to respond immediately during high-risk infusions.
Who is the Principal Investigator or designated sub-investigator?
These safety reports, including MedWatch, CIOMS, and SUSAR, are received by investigators from sponsors or CROs.
What are IND/IDE safety reports?
This meeting focuses on reviewing trial processes after the initial dosing visit to improve safety and efficiency for future visits.
What is the Visit Debrief?
This action must occur with investigational product after a confirmed temperature excursion until sponsor guidance is received.
What is quarantine (or moving and quarantining the product)?
This is how the CTRC RN must initially contact the provider in the event of an infusion reaction.
What is a direct phone call?
This group is responsible for identifying and providing reportable unanticipated safety reports directly to the study team.
Who is the sponsor (or CRO)?
This meeting provides a forum for the PI, regulatory, finance, and study leadership to evaluate whether a research study can be successfully implemented.
What is the Feasibility Meeting?
IDS staff must respond to temperature alerts within this amount of time when managing excursions.
What is 30 minutes?
This must occur if the study provider is not physically present on the Anschutz campus before a high-risk infusion begins.
What is pausing (or potentially canceling) the visit?
The PI only reviews safety reports that meet this designation, defined by OHRP criteria including unexpectedness and increased risk.
What is an unanticipated problem?
This meeting serves as a comprehensive review of what is involved in implementing and running the clinical trial.
What is the Logistics Meeting?
This system provides continuous electronic temperature monitoring and records data every 15 minutes for IDS storage areas.
What is SensoScientific?
This review process determines whether an investigational product is considered high-risk before being administered in the CTRC.
What is the Operational Needs Assessment (ONA)?
One required criterion for report review is that the event must also lead to these types of impacts on the study.
What are changes to the conduct of the study?