Role Level
Systems
Issues
Mixed Bag
Miscellaneous
100
What level does the CTL sit on?
Trial level
100
By default, is your Outlook Inbox a two year folder?
No, it is a 90 day folder
100
What is an IPD?
Important Protocol Deviation
100
The alias for Learning One Source is?
LOS
100
Who is responsible for resourcing the west of the Mississippi?
Kim Skemp
200
What level does the Site Monitoring Manager sit on?
Local country
200
Yes or No? When you login to the computer with your user ID and password, do you have access to the BI Intranet?
No! You have to access the BI Intranet through Global Protect ( Pin number & key fob numbers)
200
What should the CRA do immediately if they find a potential severe issue?
200
The alias for Knowledge Management Medicine is?
KMED
200
Who is responsible for resourcing East of the Mississippi?
Janine Eagle
300
What level does the Site Monitoring Lead sit on?
The trial level
300
What system do you enter your time in each day?
TimeRecorder
300
True or False Is this an example of a Severe Issue?
During IMP administration a subject was dosed with the incorrect IMP from a different Clinical Trial ( with different indications) administered via an incorrect route (IV instead of IM)
True,
There was likelihood to significantly impact the subject’s
safety.
300
The alias for Password Reset is?
PaRes
300
In what year was BI founded?
1885
400
What level does the Clinical Trial Mansger sit on?
Local/Country level
400
Are you expected to complete all learning items in LOS on time?
Yes! Otherwise, you will end up on the Non Compliance list
400
Is this a potential Severe Issue?
IMP administration: A subject took IMP that had expired two days ago. The IMP stability report from CTSU showed that the IMP was still within the effective range
No, there was no impact safety/rights of the subject or on the reliability and robustness of the data generated of the trial. In addition, the assessment of the issue identified this as a single episode and a detailed corrective and preventative action plan was implemented.
400
What is the name of the BI portal system
Clinergize
400
Who owns Boehringer Ingelheim?
The Boehringer family
500
What level does the MRA sit on?
Local/Country
500
What KMED asset can assist you in determining BI acronyms?
e-Glossary
500
True or False Should all protocol deviations be entered into BICTMS?
True
500
Can CRAs fill out a MyShop form?
No! The managers have to complete the MyShop form for CRAs to receive software, etc.
500
What are the three levels that trial colleagues sit on?
Local/Country, Trial, & Project level