RDC
Adverse Events
Trial Start Up
Who does what
SOPs
100
What is remote data capture
What does RDC stand for
100
Serious adverse event
Is skin cancer newly dx in the middle of a trial a non serious adverse event or a serious adverse event
100
The fully executed contract, regulatory document release, signed monitoring manual, release of drug is completed, & IRB/IEC approval
What are five of the items the CML/MRA must be sure are in place prior to any TIV taking place?
100
CSI/Site Feasibility
Who provides potential investigator packets to the CMLs on an ongoing basis?
100
The Financial Disclosure Variation
Which SOP has a current variation that talks about the PIs responsibility to advise the sponsor of any changes to their financial situation
200
RDC Flyers. They can be downloaded from the RDC website
What can the CML give the sites to explain the RDC processes?
200
It is an event called out in the protocol that will be captured and processed as a SAE for this particular trial. The event itself could be non serious but it will get processed as a SAE
What is a significant adverse event?
200
Yes
Are the CML/MRA responsible for ensuring any trial equipment is sent to the sites prior to TIV?
200
The RDC Administrator
Who works with the CRAs to provide them with the individual sites RDC passwords at the TIV
200
Changes to 1572 (Submission of Revised Investigator Study Site Information via Form FDA 1572 and Notification of Site Closures)
Which SOP indicates that the MRA/CML must have the wet signature come in house when their are changes to the PI
300
CML/MRA
Who enters the sites contact information in to CTMS system to facilitate the sites access
300
Patient, reporter, product, & event
What are the four items needed to be sure you have an adverse event?
300
The CRAs are emailing these three groups.
Who is emailing their confirmed TIV dates to the CML, CRA mgr, & CFO?
300
The CML
Who is currently responsible to review all TRIP reports sent in by the CRAs, sign the reports, scan a signed copy to service CFO, & upload into CTMF?
300
The IMP SOP ( Management of investigational medicinal product)
Which SOP describes the process on how our international distribution system (IDS) process works with distribution partners (DP)
400
Yes it is true
Is it true that upon receipt of contact information in the system the RDC Helpdesk starts contacting the new sites to perform the site assessment?
400
The Always Serious List is a listing of many different diagnoses that BI as a company has decided to always treat as serious adverse events.
What is the Always Serious List
400
The CML
Who is responsible for the investigator meeting when it is local?
400
The MRAs
Who is working with the CML and often making calls to sites & recording the summary of the call on the Site Contact Form?
400
The Protection of Subject/Patient Confidentiality SOP
What SOP speaks to patient privacy and protecting it throughout the trial?
500
To discuss the logistics regarding RDC site set up
Why do they have an RDC kick off meeting?
500
In the ISF
Where would a site find direction on how to complete the paper SAE form if the RDC system goes down?
500
The CML is responsible for the recording of the local investigator meeting including the attendance sheets, certificates, & submitting into CTMF
At a local investigator meeting, who is responsible to document the training, provide certificates, & submit into CTMF
500
The LRDR
Who is working with the CML & providing a weekly spreadsheet to the CML, CRA mgr, & CRA to keep them up on the status of the regulatory documents?
500
The Site Feasibility SOP ( Local document). Remember there is a corporate document that the LWI supersedes
What LWI describes what our site feasibility group does in the US to support the CMLs in selecting potential PIs?
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