Systems
Which system gives employees within the Medicine organization access to all available SOPS and HTGs?
KMED
Name the two checklists that must be completed by a CT Manager before a CRA can conduct an SIV.
Site Initiation Checklist and Site Release Checklist
What is the name of BI’s global repository of all clinical trial documentation (Essential Documents) as determined by ICH/GCP and BI requirements?
Trial Master File – TMF
What are the 2 main types of issues?
Protocol Deviations and Administrative Actions
Where can the Always Serious AEs list be found for the site?
ISF and/or included in BRAVE
What is the user keyword BI uses to create a confidential email?
<confidential>
What document should the CRA reference to confirm training requirements?
Trial Training Plan
Name two examples of documents you would expect to find at the Center Level of the TMF.
Signed contract, completed CV, completed logs, signed Financial Disclosure questionnaires, Protocol signature pages, approved Informed Consents, etc.
How do you document an update to an open issue?
Document the change in the action field with the date of the update. Do not delete the original action
The CTM and CRA are members of the trial or local team?
Local team
What is the recommendation for how often you should log hours in TimeRecorder?
It is recommended to log hours daily.
When should a CRA enter the ‘ACTUAL’ Site Initiation Event Date in MySites?
After the visit is completed and before starting the SIV report in MySites
Name 2 example criteria of how to assess PI oversight?
accessibility to PI, involvement in consent process and/or AE/SAE assessment, assuring site staff training, documentation of subject oversight in source, inappropriate delegation of responsibilities
What criteria must be met in order to include an issue in a FUL?
Issue is open AND Issue is NOT ticked as ‘Exclude from FUL/Escalate study+country issue’
Who is the VP of Clinical Operations
Marie-Claude Raymond
Who is responsible for completing your learning assignments on time within LOS?
I am / You are responsible for making sure all learning assignments in LOS are completed on time to remain in compliance.
How are the finalized SIV Report and FUL provided to a site?
via Clinergize
What 3 things are REQUIRED when you plan a visit in MySites?
Visit Start Date, Visit Type, CRA Name
What do CRAs use ClinSights for?
To have a holistic overview of site level issues
Who is responsible for resourcing CRAs west of the Mississippi?
Kim Skemp
What must the internet explorer zoom level be set at in order for LOS and KMED to run correctly?
The internet explorer zoom level must be set at 100%
Name two of the Clinergize CRA responsibilities.
Communicating the purpose and benefits of Clinergize during the SQV; Reviewing the TOC at the SIV and determining how the site plans to use Clinergize; During SIV and throughout trial: explaining activities that the site staff is responsible for, including which kind of information and trial documents will be available and managed through Clinergize; Notifying the CT Manager / MRA of staff who need Clinergize accounts; Providing help to the site; Reviewing Clinergize with sites; Being aware of trial updates distributed in Clinergize; Verifying site document workflows are completed / acknowledged on an ongoing basis; Reminding sites they will have to maintain and upload current versions of regulatory documents throughout the trial – they should work with their assigned SRC (RDR))
What is the only visit report where comments for specific checklist questions are expected?
Site Qualification Visit Report
How do you access Clinsights?
Type ClinSights into your browser
Who is responsible for resourcing CRAs east of the Mississippi?
Janine Eagle