Acronyms
Trial Start Up
Trial Start Up/Conduct
Trial Conduct
Mix
100
What is SFQ & when utilized
Site Feasibility questionnaire & used during site feasibility
100
Name two things that have to be in place prior to TIV
Fully executed contracts, Regulatory Release, Monitoring Manual signed, IMP release, Equip site needs, Supplies site needs, etc.
100
Who must remind the PI & SI of their responsibility in regards to Financial Disclosure?
The sponsor via the trial team
100
What is the purpose of the Investigator Meeting(IM)?
The purpose is to educate, assure common understanding of the protocol, trial management, & GCP responsibilities
100
What document would you capture a call from a site advising you that they did not report an SAE
Site Contact Report
200
FDF
Investigator Financial Interest & Disclosure Statement Form
200
What group collects the initial 1572 & submits to TMF?
Regulatory Review Group
200
Do we have only a Corp SOP on Informed Consent?
No there is a LWI Informed Consent
200
What is the purpose of the Trial Initiation Visit
The initiation visit ensures the investigators have all the required items and understanding of protocol to enroll subjects. Information/training, trial material/equipment, essential documents, IMP review, access to systems
200
In the Legacy Process what document would a CRA document a visit to a site that was a directed visit not a POV?
Further Visit/Phone Form
300
What is LDS and what do they do
Lead Document System and they review all documents submitted to TMF staging and place in the TMF
300
Who must the FDF be obtained from?
All appropriate staff who are involved in the trial and involved in treatment of subjects & when ever anyone new joins the staff
300
How many types are of Informed Consent are there (hint second is for when the subjects provide samples as part of the study)
Informed Consent & Pharmacogenetic
300
Describe the difference between entered and enrolled?
Enrolled = signed informed consent Entered = they are given medication (assignment)
300
To get to the webpage on Risk Based Quality Monitoring what "alias" would you enter into the address bar to get to the Risk Based Quality Monitoring page
RBQM
400
BICTMS and name one system under that umbrella
BI Clinical Trial Management System PROGRESS, MySites, CCT, IDM, Reports
400
If the SI for the trial becomes the PI what form(s) need to be completed by site
The site must complete a 1572 to indicate the change in position from SI to PI. Site does not have to complete Finacial Disclosure because SI already filled on out at start of trial and as long as he/she has not had any change in finances do not fill out another one
400
Are Clinical Trials required to be published on a websites?
Clinical trials must be published on a website= Clinical Trials.gov As a company we utilize also Clinical Trials Register.eu
400
Who is responsible that the trial is effectively monitored despite delegation of activities?
CML/MRA may delegate task to appropriately qualitified team members but they hold ultimate responsibility for those tasks
400
Your CML is asking you to find the Site Contact Report in IDEA for CON. How do you get there from the IDEA for CON Portal Page to bring up the document using the browse functionality not a quick find
Click on Idea for Con Europe, English Interface, then select IDEA for CON cabinet, Select BIP-US-Medicine, Select SOP/WIs, Select 40 Study Preparation, Select 40-201 Local WI 01 BIPI Monitoring, Select 003-MLW-40-201-01_RD-06a =Title Site Contact Report
500
What is RBQM?
Risk Base Quality Monitoring
500
What countries are FDF collected from?
All countries
500
Where must the discussion and documentation of Informed Consent be kept
It must be kept in the medical record. The PI should be documenting that they gave the subject a copy of the consent, date of IC, & that subject was given time to ask questions
500
Describe a few different types of Monitoring?
Direct Site Contact, Remote Monitoring/Risk Based Monitoring, Periodic On-site Visit Reports, Vendor Reports
500
Who does Regulatory Document Review Group (RDR) notify when they receive revisions of the 1572 to ensure the sponsor is compliant with FDA requirements for an investigative new drug application?
RA=Regulatory Affairs
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