Trial Start Up/AE
Trial Conduct
CAPA
IND
Trial Close Out/RDC
100
What group provides the CML with packets of potential investigators on an ongoing basis as they are vetted?
What is CSI/Site Feasibility
100
Is it true that we automatically create a new ICF if there is new safety information? Who decides whether we do or not?
No it depends on the TMM & TCM decision based on new safety information. If they feel re-consent is needed they will advise the CML
100
What are the four classifications of CAPA
Critical/Major/Comments/Minor
100
Are the CRA mgrs now required to send in a spreadsheet of all the CRAs TIV confirmed visit dates
Yes as part of new IND new quality plan
100
How do investigators access the Always Serious List(Implied AE) in the RDC system?
There is a link in RDC for the list
200
A PI calls you and advises they have a patient who just informed them that she is pregnant. The PI ask what form they need to complete and send to GPV in 24hours. How do you respond?
The MRA would tell the PI to go into the ISF and pull the Pregnancy Monitoring Form & complete side A of the form and send to GPV. Side A= Mom info Side B= Delivery info
200
who is responsible for the version control of re-consent forms?
Who is the CML
200
If a CRA finds a site dispensed a wrong medication kit is this a non compliance
Yes this is likely a major
200
Do the CML/MRA have to enter the LPO date into CTMS ?
Yes this is their new requirement from IND quality plan put in place
200
What happens to the security of the RDC access for PIs at the time of DBL
It flips to query only
300
What criteria has to be met for a CML to grant a waiver for a PTCV?
What is the site has been visited by a BI CML/CRA/MRA within 12months & The site has not had staff turnover The site has received good reviews in past The trial is in the same therapeutic area as the new trial
300
What does CDA stand for?
Confidential Disclosure Agreement
300
A MRA receives a call from a site stating they did not get secondary consent on a subject before blood was drawn and sent to lab. Is this a non-compliance.
Yes. This is a critical as the safety of the patient was at risk
300
What is the time frame the FDA gives sponsors to notify PI of new safety reports
What is 15 days
300
Does the CML have to ensure all the equipment for the trial is back from the site before TCV ?
Yes
400
You receive a call from a site coordinator who tells you that the subject who was just seen has "pancreatitis" which is listed in protocol as a Adverse Event of Special Interest (AESI), she asked, "Since this is a non serious event, I do not have to rush to get this to GPV, right?" How do your respond?
You should advise site coordinator that an Adverse Event of Special Interest goes to GPV in SAE timelines which is withing 24 hours.
400
Can you sent a SFQ out to a PI without a CDA?
No there is trial proprietary information in the SFQ
400
Is it a non-compliance if a site dispenses expired product?
Yes. This is critical as safety rights of patient impinged upon
400
Who does the CRAs submit their email with their confirmed TIV date to?
The CML,CRA management, & Service CFO.
400
What form do MRAs Use to capture calls they make to sites?
Site Contact Form
500
Is it true that for a patient unable to provide IC that a legally acceptable representative for that patient be present during the IC process and must be provided with all relevant information including SI & ICF
True
500
Who approves the CMLS list of potential investigators in the US ( LWI)?
The listing is sent to Execu Director of CTM and they approve the list ( This is the local process for the US)
500
What is the time frame to get a NC Alert Form into the Compliance Group?
7 days The whole CAPA has to be done in 28 days.
500
Who is entering into CTMS the actual TIV date that the CRAs visit PI into the First IND Safety Date field? Who is checking this date when they review the TRIP reports?
CA The CML/MRA are checking the field in CTMS to ensure it matched Trip report date
500
When drug destruction is going to be done at the site for an oncology trial who is responsible to obtain the CoD? What has to be done prior to drug destruction at a site by the CRA?
The CML. Drug Accountability has to be done before destruction at site & also before drug is picked up if drug destruction is being done at CTSU and our DP are picking up the drug for destruction at CTSU. In this scenario TCM is responsible to obtain the CoD
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