What group provides to the CML a list of potential investigators?
COS - Clinical Operations Support
100
Who is manages the trial at the trial level?
TCM
100
What form do the sites complete to notify us of changes in a PI or SI role?
The 1572 Form
100
Do we send our sites RDC Flyers to remind them of activities around Trial Close Out?
Yes we do
100
What does CDA stand for?
Confidentiality Disclosure Agreement
200
Who is responsible for training the CRAs for the PTCVs?
CML
200
Who assist the CMLs in meeting trial milestones?
The MRAs
200
What form indicates the investigator's financial status?
The Financial Disclosure Form
200
At database lock can a site change any data in the RDC system?
No! Once database lock occurs the sites access to RDC is read only. The Flyer is sent prior to this and reviews this access change.
200
What is RADAR?
The website for Risk Base Monitoring
300
What form must be in house and signed prior to the CSI group sending out a FDQ?
CDA= Confidential Disclosure Agreement
300
Who goes to the sites and is the eyes and ears for the CML?
The CRAs
300
Do we ask a SI who started with our trial that is taking over as the PI for the trial for a new financial disclosure form?
No this would not be needed because the RDR group collected at trial start up as part of regulatory document release
300
Does the Trial Close Out Visit have to occur at database lock?
No! Typically the Trial Close Out Visit is done any where from database lock date till 3mo after.
300
What does PTCV stand for?
Pre Trial Contact Visit
400
What does IIQ stand for?
Initial Interest Questionnaire?
400
Who manages the CRAs?
CSMG manager
400
What forms will the site have to complete if a brand new SI joins the trial site in the middle of the trial?
The Financial Disclosure Form and the 1572 Form
400
Are sites completely locked out of the RDC system 6wks after receiving their patient data report CD?
Yes! This does happen. As an MRA you have to be aware that at database lock the sites can no longer enter into RDC but can only read their data. 6wks after they receive a CD with all their patient data report (PDR) CD they will be locked out of RDC all together for the trial they were working on.
400
What is one type of monitoring available to the CML & their clinical team?
Direct monitoring (email, phone, newletter)
Remote (Risk Based Monitoring)
Periodic On Site monitoring
Vendor monitoring (lab/IRT)
500
What does SFQ stand for?
Site Feasibility and Selection
500
Who reviews safety data during the trial and determines the need for reconsents?
TMM & TCM - Team Member Medicine & Trial Clinical Monitor
500
Give me one step the CML/MRA must complete upon receipt of the 1572 from a site?
Complete a 1572 Change Form, Submit the 1572 Form & 1572 Change Form to the TMF, Notify the RA group by email, & enter changes into CTMS
500
Can a CML close a site early for no enrollment?
Yes the CML can close the site for low enrollment or no enrollment. They always keep the TCM aware prior to closing a site early.
500
If a PI has a case of Drug Exposure During Pregnancy, what form does he/she complete and send to Global Pharmacovigilance in 24 hours to make them aware?