Gayle's Quiz
Which date does the CRA have to enter into MySites prior to starting an SIV report?
The SIV Actual Date
Where are the BI global headquarters located?
Ingelheim, Germany
What system is used to track site visits?
MySites
True or False: When using the Almac returns portal for scheduling pick-up of IMP, login credentials are required.
False. There are no login credential
Auxiliary Medicinal Product
True or false: Whoever opens/creates an issue does not have to close the issue – the issue can be closed by anyone on the study team once an update is received.
False. Whoever opens/creates and issue should close the issue.
Where are the US headquarters located?
Ridgefield, CT. USA
Name at least 2 primary features of MySites?
Answers: Issue management, Checklists, Monitoring Visit Reports, and Event Dates
For SMV and SCV visits, the Site Visit Report (SVR) should be completed in how many business days?
5 Days
What does CTP stand for?
Clinical Trial Protocol
True or false: For any type of report (i.e., SQV, SIV, SMV, SCV) it is ok to capture some issues, like administrative issues, in the comment field of reports.
False. Issues should only be captured in issue management, not in the comment field or narrative of a report.
What level does the CTL sit on?
Trial level
Name the 2 Distribution Partners we work with for IMP Management
ALMAC and Fisher
What does SQV stand for?
Site Qualifying Visit
What does IQRM stand for?
Integrated Quality Risk Management
Clinergize does not maintain any original essential documents (e.g. completed Financial Disclosure Form, CV) for the site. True or False: If a copy of an original document is uploaded to Clinergize, the site is required to keep the original in their local files.
True
What level does the Site Monitoring Lead (SML) sit on
Trial Level
Who is responsible for creating the Subject ICF Tracker template. Is it the MSL CTM, or MRA?
MSL from slide 18/ ICF Tracker
What does SMVR stand for?
Site Monitoring Visit Report
What does OPU stand for?
Operating Unit (e.g., US, Canada, Japan, etc.)
What are the names of the two IRT systems that BI uses?
Answer: Almac and Clinphone Perceptive
What are the CO US only local roles?
MRA, Site Monitoring Manager (SMM), and CA * Remember CTM and CRA are global roles
The CRA is responsible for submitting which visit Follow Up Letter to the site.
Site Qualification Visit (SQV) report
What does SIV stand for?
Site Initiation Visit
What does STORM stand for?
Storage Conditions for Trial Medication