Site Feasibility
Trial Initiation/Conduct
Trial Initation/Conduct
IMP
Mix
100
Who is the group responsible to provide a pool of investigators to the CML to review and select from for their trials?
The site feasibility group/CSI group
100
Is it true that the CML must coordinate and confirm they have the following before trial initiation" Fully executed contracts, Regulatory Document Release, A signed Monitoring Manual, & Released IMP to sites
This is true
100
Where can a PI find the Always Serious Adverse Event List (Implied Serious List)? What is this list?
The Always Serious Adverse Event List is found in the ISF for paper SAE trials and a link in RDC trials. This is a list that BI as a company deems the events regardless of context of the report must always be submitted as SAE.
100
A site coordinator calls you and states that all the patients at the site are complaining of a "metallic taste" since they received these new kits. What would you do if you received this call?
Collect information about the kits (lot # and expir dates) and have site complete the product complaint form. Notify the CML as this is a possible recall situation.
100
Does everyone who has access to RDC have to complete an RDC e-learning?
Yes
200
Can a SFQ (site feasibility questionnaire) go via regular mail to a PI?
No. It needs to go by secure mail
200
Can the CRA complete a TIV if the investigator has not received or show documentation of attending an investigator meeting
No TIV can occur in this situation
200
What action should the CML/MRA take with Trip reports after they review them?
The TRIP report should be signed and dated and a copy is sent to Service CFO & the CML uploads it into CTMF
200
A new site just received their drug and they have down loaded the Epro temp logger. This trial is using IRT system what else will the site need to do inorder for the CML/CTSU/CRA know they received the drug
They need to go into IRT system and select "Drug Available" this lets everyone know they received drug okay.
200
Does every OPU have the CRA Manager role?
No
300
What must the CML have prior to letting CSI group send out a SFQ?
What is the CDA
300
Who is responsible to organize the local investigator meeting?
The CML
300
A CML/MRA are reviewing a TRIP report and discover an egregious error. The CRA put the wrong site number on the TRIP report. What does the CML/MRA do?
They should "print" their name at Functional/Reviewer field and return the Trip report to the CRA mgr with a Feedback form identifying the egregious error. ***Normally a TRIP report is considered a final document**
300
What must the CML ensure is in place prior to signing the release of drug for shipment?
The CML must ensure there is a CoA and that they have IRB/IEC approval & that the CTSU has CoC and any other documents if drug is imported
300
Who is responsible to enter the confirmed TIV date in the "First IND SR field" in CTMS?
Who is the CA
400
Is it true that the CSI group will vet all the potential investigators prior to delivering the investigator packets to the CMLs?
Yes this is true
400
Is it true that the CML must document, archive, & upload all training materials, agendas, & attendance list in CTMF after IM training?
Yes this is true
400
A CRA is onsite monitoring and the PI ask, " What do I do when a subject tells me they are pregnant?"
The PI needs to pull the Pregnancy Monitoring Form and complete side A sign it and fax to GPV within 24 hours
400
A trial is using IRT system and the decision at the beginning of the trial is to return drug to BIPI and then destroy at CTSU. In this situation who is responsible to obtain the CoD (certificate of destruction)
The TCM is responsible in this situation and will need to upload it into CTMF
400
A CRA has come to a site and found that subject 001 has not signed an Informed Consent. What action should the CRA take?
The CRA should instruct the site to try to obtain informed consent now. The CRA should contact their trial team and begin CAPA process. The CRA may begin completing Non-Compliance Alert Form. The CRA captures in TRIP report that they found Non-Compliance and that trial team notified. THEY DO NOT DOCUMENT CAPA IN TRIP REPORT
500
A site calls you and they ask why must they complete and sign another CDA when they already have signed one for another BIPI trial
CDA's are trial specific. If you are working on six BIPI trials you will complete six CDAs.
500
What form do the MRAs utilize to capture important conversations around the trial they have with the site?
What is the Site Contact Form
500
Who is responsible for the lenght of the trial to continually review TRIP reports for manual protocol violations?
Who is the CML
500
A trial TCM has made a decision at the end of the trial to destroy drug at the site. Who is responsible to obtain the CoD in this situation?
The CML is responsible to obtain the CoD in this situation and send it to the TCM
500
A new subject signs the IC today at 3pm and leaves the site and is hit by a car and has to be admitted over night to ensure they are okay. They experienced an elevation in their BP that had to be evaluated. What should the PI do?
The PI has to create an SAE. We begin taking in SAE reports as soon as consent is signed regardless of whether the subject has taken drug or not
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