Miscellaneous
What is the name of BI's eISF?
Clinergize
What document will you receive prior to conducting a SQV?
Site Feasibility Questionnaire (SQF)
How many SOPs do we currently operate under in Site Monitoring?
9
What is the name of the document that captures training requirements for the site staff?
The Trial Training Plan
If there are no STORM documents for the compound what document do you complete if there is a temperature excursion at the site?
The Product Device Complaint Form is completed
What are the 3 levels of documents in the TMF?
Trial, OPU (Country), and Center (Site)
Only general SQV training is required for CRAs prior to conducting a trial specific SQV ( True or False)
False: Trial specific SQV training is required before conducting trial specific SQVs
CRAs must reconcile the TMF against Clinergize? (True/False)
False- RDR (SCR) group does this.
What is the name of the document that captures training requirements for BI staff
The Trial Training Plan
The documentation of all IMP delivered to the site, used, unused and/or destroyed must be verified and reconciled on unit (e.g. capsule, tablet, vial etc.) level. Is this True or False?
True
Who at BI works with site staff during the start-up phase to ensure regulatory document completion prior to the SIV?
SRC (Site Release Coordinator) aka Regulatory Document Reviewer (RDR)
If a site qualifies for a SQV waiver, there is no need to conduct this visit? (True/False)
False- A SQV waiver approval waives the need for the visit to be completed on-site. The visit must be completed but maybe conducted by phone.
Who completes the Site Release Checklist?
The CTM
The SIV must be completed within ____ business days from the date of completion of the Site Initiation Checklist.
10 days
What is the minimum frequency for a site to record min/max temperatures of a medication storage location?
At least once a week
Who informs site/investigators of decisions regarding site selection?
CTM
Who gives the approval for an SQV waiver?
CTM
The CTM
The CRA
What form do you complete if the site informs you that they have satellite sites?
Satellite Checklist
BI requires all investigators to complete ICH/GCP training within ________years prior to _____ and the training must meet ______________ criteria
3 years
SIV
TransCelerate criteria
Do we need to have a contract and budget in place prior to conducting SQV?
NO! CDA.
Which checklist(s) must be completed prior to conducting the Site Initiation Visit (SIV)?
Both the Site Release Checklist and the Site Initiation Checklist must be completed prior to SIV
Within how many business days do you have after a monitoring visit to submit the visit report, get it approved by the CTM, finalize the report, & complete the visit in MySites?
10 business dates
Which two IRTs are currently used at BI?
Almac and Parexel Perceptive