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Mix Bag
Site Monitoring
BI Organization
Abbreviations
Site Monitoring
100

What does SRC stand for?

Site Record Coordinator

100

  • What checklists must be completed prior to SIV?  

  • The Site Release Checklist
  • The Site Initiation Checklist

Both

100

Who is the Ex. Director of Site Monitoring?

Stephen Lazzari
100

  • What does CTP stand for? 

Clinical Trial Protocol

100

 If you want to ensure a Issue shows up in the Follow Up Letter, what do you need to do? 




Assign the issue to the Investigator in the site staff field


200

How many times does the Investigator need to document that they requested the medical records for the subject?

At least once (Kim will expand)

200

  • Within how many days of SIC sign off must SIV be completed? 

In 10 days

200

Who is the VP of Clinical Operations

Marie Claude Raymond

200

What does TLMM stand for?

Trial Level Monitoring Manual

200

True or False:  Is a finalized SIV Report provided to the site? 


True a finalized SIV report is provided to the site


The SRC/RDR provide it to the site

300

  • Relating to Essential Documents, what kind of document is provided to every subject enrolled in a BI trial (hint, it’s a card)? 

The Trial Identification Card

300

  • Within how many days from visit is SIV Trip Report due? 

Must be submitted within 5 days

300

Name one member of the Site Monitoring Leadership Team besides Stephen Lazzari ( Senior AD or AD)

Kim Skemp

Janine Eagle

Mark Bennett

Kurt Wenstrup

300

What does SML stand for?

Site Monitoring Lead

300

  • What’s the timeline for CRA to send out the SIV Follow Up Letter? 

Trick question:  COPI sends out our visit letters

400

True/False: In Clinergize, the  Follow Up Letters can ONLY be acknowledged by PI? 

False,

400

  • When is Informed Consent obtained? 

Prior to any study procedure (e.g., fasting, holding meds, being given IMP)

400

What level does the Site Monitoring Leader sit on?

What level does the Site Monitoring Manager sit on?

Trial Level=SML

Local Level=SMM

400

What does BICTMS stand for?

Boehringer-Ingelheim Clinical Trial Management System

400

Are CRAs responsible for monitoring TMF against Clinergize?

No! The CRAs are not responsible to do this

500

Aside from SOPs and HTGs, what BIPI document MUST be followed for all trials starting from trial initiation and on? 

The Trial Level Monitoring Manual (TLMM)

500

  • How long must site archive trial records at closure? 

15 years or according to local laws and based on contract at SCV

500
Are you responsible to call the call center if you are made aware of an Adverse Event on a Market BI Product?

Yes! This is why you are given the laminated card with the 800 number for the call center that takes in the AEs.

500

What does PD stand for?

Protocol Deviation

500

  • True/False: CRA is responsible for reconciling sections of TMF and ISF? 

True! The CRA is responsible for reconciling sections of the TMF and ISF