IMP & AMP
Investigational Medicinal Product
What system do you find KM assets, SOPs, HTGs in?
KMED
What level does the Clinical Project Lead (CPL)/ Team Member Medicine (TMM) sit on?
Project level
How do you make an email encrypted?
Place <Confidential> at the subject line
What is the Implied Serious List at BI?
It is a BI list of adverse events that are always Serious
What are the STORM documents used for?
These documents give BI additional parameters when the product is out of temperature recommendations
What is the name of our portal system?
Clinergize
What level does the MRA sit on?
Country/local
If you find that LOS and KMED sites are not functioning correctly?
Go to the tools cog at the top right hand of screen and adjust your zoom to 100%
Can we accept GCP training certificates from TransCelerate members
Yes
What does AxMP?
Auxiliary Medicinal Product
What do we call our BI intranet portal?
My BI
What level does the CTL sit on?
They sit on the trial level
How long is the retention period on our Outlook Inbox?
90 days
What is the timeline for Drug Exposure During Pregnancy (DEDP) cases?
24 hours
What are the IRT systems?
BI uses two IRT systems:
Almac's IXRS
PAREXEL's Perceptive
What system do the PIs complete the Case Report Form in?
BRAVE
What level does the Site Monitoring Lead (SML) sit on?
The trial level
Who is responsible to manager your LOS plan?
You:)
You should go out and be looking at what is coming do
What does AESI stand for? What is the timeline these events go to GPV?
Adverse Event of Special Interest. Timeline to GPV is 24 hrs
Who determines which IRT system will be used for a clinical trial
CTSU (Clinical Trial Supply Unit)
What system has "Progress", "My Sites", "Investigator Database Management", "CCT", & "Reports"
BICTMS
What level does the Site Monitoring Manager and CRA sit on?
Country Local
How do you remain compliant in LOS?
Complete all items on your LOS Plan on time
How can you get email updates on HTG from KMED?
By setting up a Notification in KMED