The IRB
By federal rule, the IRB should include at least one _________ and non-_________.
What is a scientist?
Subparts B, C, and D of the federal regulations specifically call out protections for these three categories of participants.
What are pregnant women and fetuses, prisoners, and children?
A compilation of the clinical and nonclinical data on the investigational product which is relevant to the study of that product in human subjects.
What is the Investigator Brochure?
Once seen as a party drug, this is gaining interest in the treatment of depression with clinical trials underway across the nation.
What is ketamine?
Electronic platform that can be used to create eConsents.
Musical sounding acronym for the Accreditation body for Human Research Protection Programs.
What is AAHRPP?
(pronounced A-HARP)
Alpha/Numeric mechanism by which devices are cleared by the FDA for marketing.
What is 510(k)?
Both ________ informed consents and _________ informed consents should be as part of a study's documentation.
What is blank and signed?
A smartwatch used to collect real-time heart rhythm data from participants in a clinical trial is an example of what kind of technology.
What is digital health technology (DHT)?
Often confused with severity, this assessment of an adverse event is based on outcome - when things result in death or hospitalization, for example.
What is seriousness?
What is a serious adverse event?
This is the word that indicates a minimum number of IRB members that must be present for a vote.
What is a quorum?
This office provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).
What is OHRP?
Who is responsible for notifying the FDA of drug related adverse events in a clinical trial?
Who is the Sponsor?
Who is the Sponsor-Investigator?
Known as a RCA, this type of analysis can be a vital step in developing and writing a CAPA.
What is Root Cause Analysis?
The exemption category can used for chart review submissions to the IRB.
What is Category 4?
This Act, signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.
What is the 21st Century Cures Act (Cures Act)?
In ICH GCP, the ICH stands for this.
What is International Council for Harmonization?
Initiation, Planning, Execution, Monitoring, and Controlling and Closure are all steps in this cycle.
What is the Project Management cycle?
This type of chart, used often in project management, is a spreadsheet tool to plan and review tasks and deadlines.
What is a GANTT chart?