Site Management / Florence
Data Management
Monitoring
Unblinded
Team
100

This is the month LeAAPS ROME Randomization system was released.

What is October 2022?

100

January 25th 2023

What is the date of the first patient randomized?

100

This is the date the Monitoring database was first published.

What is 29 August 2023?

100

Emilie Belley-Cote and Mike Sharma

Who are the Adjudication co-chairs?

100

Rachel Eikelboom

Who is the Project Officer?

200

This number of emails that LeAAPS@phri.ca gets on average per week.

What is 450?

200

This feature in TrialMaster was the first to be implemented in LeAAPS at PHRI.

What is dynamic monitoring?

200

This is the number of CRAs currently supporting the LeAAPS study internationally.

What is 27?

11 in the US/Canada and 16 in Europe

200

Andre Lamy, Hatim Alraddadi, and Saurabh Gupta

Who are the Medical Monitors? (Dr Lamy is the new dedicated MM)

200

This person has been at PHRI for over 20 years, is fluent in American Sign Language and will be backcountry camping this summer.

Who is Tracy Boland?

300

This is the month of LeAAPS Florence implementation.

What is May 2023?

300

These are the number of blinded active reports programmed by stats.

What is 7?

  • Recruitment Report
  • SOER Report
  • AESAE Report
  • Demographics and Baseline Report
  • Outcome Event Report
  • Data Quality Reports
  • SOER Overall (Monitoring) Report
300

These two sites in US and Canada have had the greatest number of Interim Monitoring Visits.

What is UPMC in Pittsburgh and Hamilton General?

300

These are the number of unblinded forms entered in the Main Study data quality report as of 5am today.

What is 9640?

300

This person is a trained Indian classical singer and loves reading books.

Who is Aishwarya Sudakaran?

400

This is the average number of documents uploaded to Florence eISF each week.

What is between 120 - 250?

400

This is the approximate number of blinded queries that have been resolved in the Main Study database to date.

What is approximately 6000?

14 queries on average per day since the first patient has been recruited!

400

This site is the only recruiting site set at a Moderate Risk level.

What is UPMC?

400
These are the number of outcome events processed by the unblinded team.

What is 230?

400

This country is the most popular vacation destination in the LeAAPS Study Team.

What is Italy?

500

This is the total number of site and CRO invoices processed to date.

What is 803?

500

This is the number of forms entered as of 5am this morning.

What is 65,078?!

500

This is the number of monitoring visits we estimate to have over the 8 year study period.

What is between 1000 and 1200 SIVs, IMVs and COVs?

500

1172

What are the number of AE/SAEs the unblinded team have processed?

500

This is the number of PHRI study team staff supporting LeAAPS currently.

What is 14?

Jessica Vincent, Jane Belanger, Rosemary Howe, Sara Di Diodato, Sarah Molnar, Aishwarya Sudakaran, Kaitlyn Charnetski, Jovan Poposki, Maria Ivanova, Yael Reznick-DeMarco, Caroline Marszal, Ben Magier, Tracy Boland, Michelle Popovic