Trainer's Choice
What system can you access the CT Manager Roadmap?
KMED All Process>CO>Roadmaps
What does RACI stand for?
Responsible, Accountable, Consulted, Informed
If a temp logger is missing, malfunctioning, or no data transmission what form does the site have to complete?
Product/Device Complaint Form (See IMP Presentation slide 19)
Who is the VP of CO?
Marie-Claude Raymond
What is the timeline for reporting for events on the Implied Serious List/Always Serious List?
24 hours
What BIPI Portal System use by sites & RDR team?
Clinergize
What is the BIPI RACI Dashboard?
[10/16/2020 10:09 AM] Meyers,Julie (MED ClinOps) BIP-US-R:
Defines BIPI specific details/tasks and outlines specialized roles not represented in the SOPs to which certain trial related tasks have been delegated.
Are the Site staff responsible for confirming receipt of IMP?
Yes!
Who is the manager of the MRAs?
Laura Berchert
What form could the CTM/MRA complete, if the CRA was made aware of an SAE by the PI but the PI is refusing to report and the CTM/MRA have not yet been able to reach the PI. The CRA was advised of the SAE 23 hours ago?
SAE Memo Form
Where would you record your time if you completed training in LOS?
TimeRecorder
If the PI has completed GCP training within three years of trial initiation, do they need to complete another GCP training during the trial?
No! Not unless GCP training is updated
What checklist must be completed by the CTM prior to first shipment of IMP to a site?
How do you encrypt an email?
<Confidential>
When does AE reporting start for a subject?
When the subject signs the Informed Consent Form
Give one criteria for rational for SQV waiver?
1. Investigator is presently working on a BI trial
2. All staff facilities remain unchanged
3. Indication for trial is in same TA
4. Previous onsite visits confirm good performance
Who is responsible to ensure site staff have GCP training?
PI is responsible
What two IRT systems does BI use?
ALMAC & Parexel
Where do you go to upload a document to the TMF?
TMF Central Staging Area
Who informs the sites of the investigators of the selection decisions?
CTM/MRAs notifies all investigators of all decisions
Does the rationale for the SQV waiver have to be confirmed by the CTM & correspondence filed in the TMF? True or False
True
Do the CTM/MRA have to activate sites in the IRT system or submits a completed site specific manual form for non IRT studies at Site Initiation True or False
True they do have to do this
What does IMP and AxMP stand for?
Investigational Medicinal Product & Auxiliary Medical Product
Julie received a document with PHI did she take the rights steps if she did :
Called the site to advise and educate
Aligned with trial team to evaluate for NC and entry in BICTMS/GEMs to DPO
Sent an email to the DPO
No! Because Julie needed to send a Written Notification to the sender of the unredacted document
Do CTMs/MRAs have to review SQVR and what is the timeline they have to complete the review in?
Yes! 5 Days