Visits
What visit report(s) requires detailed comments?
Site Qualification Visit Report (SRVR)
What system will a site get the SIV FUL?
Clinergize
How do you code your time in TimeRecorder when you meet with CTM/MRA/SMM to discuss an issue at a site?
Do you select: 1. Site Management, 2. Visit Prep, or 3.LOS Training
Site Management
What does ALCOA stand for?
Attributable, Legible, Contemporaneous, Original and Accurate
What does TLMM stand for?
Trial Level Monitoring Manual
Which type of visit does not include issues in its FUL?
SQV - these issues will be captured on the site selection letter.
Who is responsible for submitting the SQV FUL to BIRDS?
CRAs
What is the name of BI’s global repository of all pertinent clinical trial documentation (Essential Documents) as determined by ICH/GCP and BI requirements?
Trial Master File – TMF or BIRDS
What does OPU stand for?
Operating Unit
The PI must complete TransCelerate approved ICH/GCP training within how many years from the SIV date?
3 years
Name 2 of the questions CRAs should ask at the start of the SMV?
1.Subject status changes
2. SAEs
3. Screening/Enrollment
4. Deviations, IMP Issues
5. Facility changes
6. Staff changes
What is Clinergize?
A sponsor web portal used for document exchange
What is the deadline for submission of SMVs and SCVs?
Bonus: What is the cut-off time?
5 week days from last day of visit and cut-off time is 5:59pm EST/ 2:59pm PST
What does RBSM stand for?
Risk Based Site Monitoring
TRUE or FALSE? The SMVR should be completed and finalized in 10 weekdays?
False: The SMVR should be completed and finalized in 5 weekdays.
TRUE or FALSE? The SMVR should be completed and finalized in 10 weekdays?
False: The SMVR should be completed and finalized in 5 weekdays.
Who should you notify when a new site staff member needs access to BRAVE?
CTM/MRA
Who is responsible for ensuring site staff complete the protocol-required training before releasing IMP to the site?
The CRA
What does SMM stand for?
Site Monitoring Manager
What is the name of the system or area where CRAs upload documents to the TMF?
Bonus: Is there a QRC to assist CRAs in uploading documents correctly?
TMF Central Staging Area
TMF Central Staging Area QRC is available in KMED to assist CRAs in uploading documents
What does SCV stand for?
Site Close-out Visit
When will sites start to receive FULs in Clinergize?
After site selection
Where do you order IMP return boxes?
Imperial Marketplace
What does ISF stand for?
Investigator Site File
Who is responsible for finalizing the Enrollment Hold Letter at the end of the SIV?
The CRAs