General Terms Flashcards
Medical occurrence associated with test article
Adverse Event
adverse medical occurrence may or may not be related to investigational device
Adverse Device Effect
experiment involving one or more subjects to determine safety or effectiveness of a drug, biologic, or medical device
Clinical Investigation, Trial, Study
individual who conducts clinical investigation
Clinical Investigator (CI), Principal Investigator
permits a device that would otherwise be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device
Investigational Device Exemption (IDE)
application, when approved, allows drug or biologic to be used in clinical investigation
Investigational New Drug Application IND
group formally designated by an insitution to review, approve initiation and conduct periodic review of biomedical research involving human subjects
IRB Institutional Review Board
IEC Independent ethics committee
REB Research Ethics Board
Protocol Deviation
any failure to follow investigational plan
except where necessary to eliminate apparent immediate hazards to human subjects
any changes to plan must be handled through IRB approved amendments
Serious Adverse Event SAE
Serious Suspected Adverse Reaction ADR
untoward medical occurrence that at any dose results in one of the following:
death
life-threatening condition
inpatient hospitalization or prolonged stay
persistent or significant disability or incapacity
congenital anomaly or birth defect
Sponsor
person who takes responsibility for and initiates a clinical investigation
Unanticipated Adverse Device Effect
serious adverse effect on health or safety
Subinvestigator
member of clinical trial team designated and supervised by CI
Subject
human or animal treated or tested with either the test article or control
Study Coordinator
employee at clinical site who assists CI organize records, schedule study activities, facilitate site visits
BIMO
Bioresearch Monitoring Program
CP7348.811
FDA Compliance program focusing on CIs w/ same objectives as BIMO
protect subjects
verify accuracy and reliability of trial data
assess compliance with FDA regs
Necropsy
post mortem exam on animal
NAI
No Action Indicated
VAI
Voluntary Action Indicated
don’t meet threshold for regulatory action and don’t seriously impact subject safety or data integrity
OAI
Official Action Indicated
regulatory actions recommended
violations repeated or deliberate and involve false info to FDA
warning letter
Notice of Initiation of Disqualification Proceedings and Opportunity to Explain Letter NIDPOE
NIDPOE
Notice of Initiation of Disqualification Proceedings and Opportunity to Explain Letter NIDPOE
