LabCorp
These samples are collected with LabCorp Kits
What are tumor tissue for MTAP eligibility, PK, and Biomarkers?
Foundation Medicine and Discovery Life Sciences perform this type of testing
What is Central MTAP testing?
This is the number of Navlimetostat tablets that come in each bottle
What is 24?
This study will use this platform for eCRF data collection
What is Medidata Rave?
Once a site identifies a potential patient and sends an email to notify the BMS clinical team, the site must do this
What is wait for confirmation on cohort/slot allocation before the patient signs the Main consent form?
This is the number of slides needed for retrospective testing (only if MTAP assessed locally)
What is 15?
This vendor is responsible for IRT and will assign the initial Participant ID
What is EndPoint?
Pumitamig and Daraxonrasib should be stored at this temperature range
What is 2 to 8 C?
SAEs must be entered into RAVE within this period of discovery
What is 24 hours?
This should never be included in the notification email
What are the patient's full name, initials, and date of birth?
The shelf-life of LabCorp Kits is this amount of time
What is 6 months?
After submitting a request, sites should expect to receive resupplies from Clario within this amount of time
What is 10 business days?
An individual weighing < 50 kg should receive this dose of pumitamig
What is 1200 mg?
Pre-screening detail, ongoing eCRFs, and open queries should all move within this timeframe
What is 5 days?
Sites should expect to receive notification of an available slot from the BMS clinical team within this timeframe
What is 1 working day?
This is the type of requisition form preferred by LabCorp
What is eReq?
This vendor issues payments directly to participants and caregivers
What is Mural Health?
Participants will receive a paper dose diary at this visit
What is C1D1?
Users must receive a passing grade of this on mandatory Rave courses to gain access to their assigned study
What is 80%?
The patient should sign the Main consent within this number of days once a slot is confirmed
What is 3 calendar days?
This type of requisition form is required for Central MTAP testing
What is paper?
This vendor issues payments to sites
What is IQVIA?
If a missed dose exceeds this timeframe, participants should skip the dose, record it as missed in their dose diary, and resume at the next scheduled time
What is 4 hours?
To continue to screening, this MTAP result must be entered
What is homozygous MTAP deletion or MTAP loss?
If a site requests a slot but one is not currently available, investigators may take this action
What is place the patient on the Study Waiting List?