Site Feasibility & Selection
Trial Start Up
Trial Start up
Trial Start Up
Trial Start Up
100
What does IDM stand for?
Investigator Data Managers
100
Who collects the 1572 at the beginning of the trial?
The regulatory group or RDR
100
In the US OPU who manages the CRAs?
The CSMG manager
100
Does a SI who agrees to take on PI role need to complete a Financial Disclosure Form if they started the trial with BI a year ago?
No. One and done unless they have a change in finances.
100
Name one criteria for the PTCV waiver?
The site staff is unchange The site staff are good performers The trial is in same therapeutic area
200
What team is responsible in the US OPU to organize a potential pool of investigators for the CMLs?
Site Feasibility
200
Do PIs & SIs sign a Financial Disclosure Statement at the start of the trial?
Yes
200
Who manages the trial on the local level?
The CML
200
How long do the PIs & SIs need to notify BI of changes in their financial status?
The PIs & SIs must notify BI up to 1 year after the study ended.
200
Where will you find the PTCV waiver criteria?
Corp SOP Site Feasibility & Selection
300
What does CDA stand for?
Confidentiality Disclosure Agreement
300
What does SFQ stand for?
Site Feasibility Questionnaire
300
Who monitors at the actual site and follows the Explanatory Notes to complete visits?
The CRAs
300
A PI leaves a trial to go move to Italy. The SI Dr. Jones is going to become the PI. What form(s) does the site have to complete to capture this change?
The 1572. The SI already completed the Financial Disclosure Form when began trial. The 1572 will identify the role change
300
What document do the CRAs send to the sites that remind the PI of their Financial Disclosure
The Follow Up Letters have verbiage reminding the sites of their obligation to notify the sponsor of changes in finances
400
What must be in house prior to a SFQ being sent out?
A CDA
400
Who manages the trial at the trial level?
The TCM
400
Who reviews safety data during the trial and determines the need for reconsents?
TCM/TMM Trial Clinical Monitor & Team Member Medicine
400
What forms will the site complete when they bring on board to the trial a brand new SI or brand new PI
The Financial Disclosure Form & the 1572
400
Are PIs in Europe required to complete a Financial Disclosure Form?
Yes! Fiancial Disclosure must be done globally.
500
Is it true that the CMLs notify the PIs that are selected for the trial by letter?
Yes the CMLs notify all PIs about whether they were accepted or not
500
Who assist the CMLs in meeting trial milestones?
The MRAs
500
At what level does the Trial CRA (TCRA )sit at ?
Trial level. They represent all CRAs at all OPUs at this level
500
What is TransCelerate?
A group of Pharma companies joining to try to streamline the trial processes and documents for investigators
500
Is it true BI is using a TransCelerate template for their Financial Disclosure Form?
Yes
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