What does SRC stand for?
Site Record Coordinator
What checklists must be completed prior to SIV?
Both
Who is the Ex. Director of Site Monitoring?
What does CTP stand for?
Clinical Trial Protocol
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
How many times does the Investigator need to document that they requested the medical records for the subject?
At least once (Kim will expand)
Within how many days of SIC sign off must SIV be completed?
In 10 days
Who is the VP of Clinical Operations
Marie Claude Raymond
What does TLMM stand for?
Trial Level Monitoring Manual
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
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
Within how many days from visit is SIV Trip Report due?
Must be submitted within 5 days
Name one member of the Site Monitoring Leadership Team besides Stephen Lazzari ( Senior AD or AD)
Kim Skemp
Janine Eagle
Mark Bennett
Kurt Wenstrup
What does SML stand for?
Site Monitoring Lead
What’s the timeline for CRA to send out the SIV Follow Up Letter?
Trick question: COPI sends out our visit letters
True/False: In Clinergize, the Follow Up Letters can ONLY be acknowledged by PI?
False,
When is Informed Consent obtained?
Prior to any study procedure (e.g., fasting, holding meds, being given IMP)
What level does the Site Monitoring Leader sit on?
What level does the Site Monitoring Manager sit on?
Trial Level=SML
Local Level=SMM
What does BICTMS stand for?
Boehringer-Ingelheim Clinical Trial Management System
Are CRAs responsible for monitoring TMF against Clinergize?
No! The CRAs are not responsible to do this
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)
How long must site archive trial records at closure?
15 years or according to local laws and based on contract at SCV
Yes! This is why you are given the laminated card with the 800 number for the call center that takes in the AEs.
What does PD stand for?
Protocol Deviation
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