SOPs
Who generates a list of potential investigators based on criteria provided by CTL
CTM
Does BI require PIs to have a GCP training effective within 3 years of trial initiation?
Yes this comes right out of the HTG PI Qualifications and Education
Who develops the country IC to adapt to the local, legal regulatory requirements?
The CTM
What is the clinical portal system used at BI?
Clinergize
What are BIs IRT systems?
Almac IXRS
Parexel's Perceptive
What does the CTM do based on completed SFQs?
CTM finalizes the list of investigators/sites for SQV and excludes those that are unsuitable
Can you name two regulatory documents that must be collected from the PIs
1872, Medical License, CV, IRB approval
What has to be in place prior to sending the Site Feasibility Questionnaire to a site
A CDA Confidentiality Disclosure Agreement
What system houses the case report form?
Brave
What does IMP stand for?
Investigational Medicinal Product
Who schedules, conducts, & reports SQV with investigators/sites identified using the SQVR template and SQVR Follow Letter?
CRAs
Who authors the TLMM?
The SML. After attendance of Integrated Quality Risk Based Monitoring (QRBM) meeting.
What is the name of the monitoring that Diane Horton described in depth yesterday? It is the new way BI will be monitoring?
Risk Based Site Monitoring (RBSM )
What system is our dashboard system?
Clinsights
Does the IMP that is sent to the sites have a temperature probe within the box that the sites have to check upon receipt?
Yes
How does the CTM notify the investigators whether they have been selected?
CTM uses the selection/non-selection letter templates to notify all investigators
Who customizes the Site Feasibility Questionnaire and sends it down to the local country level for site selection?
The CTL customizes the Site Feasibility Questionnaire and sends down to all the local CTMs to utilize during site selection
What does SIV & SQV stand for?
Site Initiation Visit and Site Qualify Visit
What system is Progress in?
BICTMS
Are email expiration dates listed on the emails you receive?
Yes
How does the CTM know that the final approved IC is available in the TMF?
CTL communicates this to the CTM by sending the version of the IC down to the local level
What are some sources for CTMs to utilize to assist them in site selection
Internally they use the investigator database ( part of BICTMS)
Externally they utilize external investigator databases such as trial trove, site trove, claims database, patient advocacy groups
Are you required to keep your LOS plan up to date?
Yes every person is required to keep their LOS plan up to date
What system do MRAs enter their time into?
TimeRecorder
What system do the SOPs and RDs sit in?
IDEA for CON