Regulatory
The Research Professional is responsible for creating and submitting an initial application to the IRB for review and approval
Who is the Study Start Up Analyst
a type of committee used in research in the United States that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans.
What is an IRB
You have 48 hours to complete this task after consenting a patient.
What is upload into Velos.
The system in which all CRCs must entered their scheduling request.
What is the Beacon Uchart
It's ok to use white out on CRF's? True or False
False
UP
What is an Unanticipated Problem
If an SAE is not listed in the ICF or IB, but occurs in the study, then that represents a _______ type of risk and could potentially be a ________.
What is unexpected
What is a SUSAR
The system that Research Coordinators and Regulatory Analyst use to record their daily tasks.
What is TAS
When writing something down, if you make an error, how many times do you line through error?
What is Once
IRB approved documents, IB, Protocol, ICF, CV's, Medical License and monitoring visit logs
What are Essential documents filed in the TMF (Regulatory Binder)
CTCAE
Common Terminology Criteria for Adverse Events
SAEs must be initially reported within _____ hours of learning of the event with follow-up reports within ____ days?
What is 24 and 30 days unless substantive new information is determined sooner.
A Research Coordinator uses this system to retrieve current study documents and document the consenting process.
What is Velos
What does GCP stand for?
What is Good Clinical Practice
The documentation that shows the PI has the responsibility of ensuring only individuals qualified by means of education, training and experience are delegated the authority to perform research related tasks.
What is the Delegation of Authority Log (DOAL)
The $5M grant SCCC has applied for.
What is CCSG
What is a PI or MD level sub investigator
MINT is used for?
What is radiology reports
Freely given ________________should be obtained from every subject prior to clinical trial participation.
What is informed consent
Applying the principles of this 6 letter acronym will help you to ensure source documentation is precise, detailed, and accurate.
What is ALCOA-C
______ and ______ types of studies are not externally monitored?
What is Coorperative Groups and Consortiums