The IRB
The IRB should review the amount and method of payment to ensure that this doesn’t occur.
What is undue influence?
Originally adopted in 1991 and revised in 2018, this regulation outlines the mechanisms and guidelines for protection for human subjects in the United States.
What is the Common Rule?
What is 45 CFR 46?
Hopefully not a napkin, these are all original documents, data, or records.
What are source documents?
The month and year that kicked off the world suddenly learning the value and complexity of clinical trials.
What is March 2020?
This standard should be used for developing and completing all research documents.
What is ALCOA-C?
According to both ICH GCP and federal regulations, special attention should be given to studies that may include _________ subjects.
What are vulnerable subjects?
This is the FDA regulation that governs electronic records and signatures.
What is 21 CFR Part 11?
These two types of "files" should be established at the beginning of the trial and kept through close-out, one for the site and one for the sponsor.
What is Trial Master File and Investigator Site File?
What is TMF and ISF?
Maybe if this woman understood the need for clinical trials, there would have been early proof that the device didn't work as she promised and she wouldn't have gone to jail.
Who is Elizabeth Holmes?
21 CFR 312 is guidance for ______ while 21 CFR 812 is guidance for ____.
What is drugs and devices?
This operates as both Master Reliance Agreement and system for tracking review and approval for studies required to use a single IRB.
What is the SMART IRB?
This is the part of the federal regulation that deals specifically with research with children.
What is Subpart D (of 45 CFR 46)?
This is the term that ICH GCP calls all those documents that individually and collectively permit evaluation of the conduct of the study and the quality of the data produced.
What are Essential Documents?
This large company shuttered its entire clinical trial division in May 2023, only two years after opening.
What is CVS?
This response to study non-compliance that is detailed in a formal plan and submitted to the IRB and other oversight bodies is known as what.
This acronym stands for the documentation of an institution's commitment to comply with federal regulations and maintain policies and procedures for the protection of human participants.
What is FWA (Federal Wide Assurance)?
The FDA requires safety reporting within ___ days for unexpected fatal or life-threatening suspected adverse reactions.
What is 7 calendar days?
When a delegation log is completed entirely electronically, this hand-written other log is sometimes required.
What is a Signature Log?
This type of study is all the rage currently, with trial-related activities or procedures being able to take place at home or other more convenient locations.
What is a Decentralized Clinical Trial (DCT)?
The most common versions of a _______ are OnCore and VELOS, which are a centralized and systematic way of tracking and monitoring study information. (April 2023 - Tech)
What is a Clinical Trial Management System (CTMS)?
Commonly confused with "faster", this is the category of IRB review between exempt and full-board.
What is expedited?
Known as a MedWatch report, this FDA form is how sponsors submit safety reports to FDA
What is 3500A?
This person holds ultimate responsibility for investigational drug accountability at a study site.
Who is the Investigator?
For the treatment of ___________, the FDA controversially granted accelerated approval of Aducanumab using a surrogate marker instead of a clinical endpoint as a measure of efficacy.
What is Alzheimer's?
Workshop materials including slides and recordings can easily be referenced in this location.
What is the BU RPN Workshop Library?
What is the UVM LCOM Commons Sharepoint - Past Workshops?