IMP/AxMP
What does AxMP stand for?
Auxillary Medicine
What does SQV stand for?
Site Qualifying Visit
Do we have to send a written notification when there is a breach in patient privacy?
Yes
What does TMF stand for
Trial Master File
Do you have to assign issues to the PI for the FUL to be generated? True or False
True
Where do we get our IMP from what group? Is it
CTSU
TMF
BICTMS
CTSU
Can a CRA do a Site Initiation Visit (SIV) without Regulatory Document Release?
No. No visit can occur until Regulatory Document Release is reached
If you are speaking to a spouse of a patient and she shares her name and her husbands name who is the subject, will you turn around and share that information with your CTM? The wife gives you the subject number & trial number from the TIC card
No! Give the CTM only the information they need the trial number and subject number. Remember even on calls you have to protect the patient's and family's privacy
True or False does the CTM work with the LTRS (Local TMF Record Specialist) to determine the local ISF contents?
True
GEMS and the Quality Management Compliance Manager
If drug stored at a site has a temperature excursion what form(s) do they complete if the temperature excursion is deemed non significant according to STORM documents?
Temperature Excursion Report and Assessment Form * CRAs help the sites with this process
Site Monitoring Visit
Do you have to educate the site that sent you in-redacted PHI when there is a breach discovered?
Yes! You should always take the opportunity to educate the site that sent in in-redacted information.
What are the two Checklist that the CTM has to complete prior to Site Initiation?
Site Release Checklist & Site Initiation Checklist
What system to we enter site issues into?
BICTMS Issue Management System
If drug stored at a site has a temperature excursion what form(s) do they complete if the temperature excursion is deemed significant according to STORM documents?
The Temperature Excursion and Assessment Form & The Product Device Complaint Form.
What does SCV stand for?
Site Close Out Visit
What are the two things you must do whenever there is a breach with your trial team?
Evaluate the incident for non-compliance and entry in BICTMS/GEMs & notify the DPO
Does the CTM document review of SIVR, SMVR, SCVR, & SQVR?
Yes! The CTM/MRAs have to document review of the visit reports in Progress (Portion of BICTMS/IMPACT system where CTM/MRAs document)
Do you ever refer to the PI or any site staff by name in an issue?
No only by role
Does IMP delivery require a two signature sign off to indicate the IMP has arrived and is intact? True or False
When a CRA indicates "No" at any question on the visit report what should the MRA look for?
An issue in Issue Management
When you receive an in-redacted document can you delete/destroy it right away? True or False
How do CTMs/MRAs/CRAs document ongoing contacts with the site outside the monitoring visits?
Documentation is captured as a Site Contact. They can utilize an email or word document to capture the contact with the site . The email or word document
Trial and Site Number,Date of Contact, Sponsor representative involved, site staff involved, topic discussed including outcome
Yes! Metric of 20 days