Exam 1 Flashcards
Internacional quality standards provided by ICH is
1-GLP
2-GCP
3-GCLP
GCP
When dealing with E signature, a password policy should be implemented to change password.
True or False
True
Internal Adverse Events that are unexpected, fatal or life threatening and related or possibly related to the research to the research intervention must be reported within
24 hr
21CFR Part 11 deals with Electronic records and Electronic signature
True or False
True
Any Serious Adverse effects on health or safety or any life threatening problem or death caused by or associated with a device, if not identified in the device brochure, protocol or consent form is
Unanticipated Adverse Device Effect
The father’s consent is needed even if the pregnancy resulted from rape or incest.
True or False
False
The probability and magnitude of physical and physiological harm in a research involving prisoners is
1-Maximal Risk
2-No risk
3-Minimal Risk
4-None of the about
Minimal Risk
CFR21 Part 11 is
Technical and Procedural
The need of record retention should be informed to the investigators/institution in
Written form
A formal process that ensures consistent operation of system as per the regulatory requirement to ensure and manage information is called.
1-Computer System Confidentiality
2-Computer System Validation
3-Computer Security Assurances
4-Computer System Accuracy
Computer system Validation
The possibility of unforeseeable risks must be taken into consideration when involving pregnant women and fetuses
True or False
True
The participant identity should be concealed as
1-Writen
2-Verbal
3-Both 1 and 2
Written and Verbal
The consent should be signed by ?
1- Subject
2-Person who obtained consent
3-both
Subject and person who obtained consent
Major sponsor of Clinical Research is
NIH
The sponsor specific document should be retained until at least _____years after the last approval of marketing application?
2 years
A study in which the mentally ill subject are taken off their regular medication?
1-Challenge Study
2-Placebo Study
3-Washout study
4-Symptoms Provocation Study
Washout Study
The sponsor should use an unambiguous subject identification code ?
True or False
True
What is IDMC ?
Independent Data Monitoring Committee
Pharma is
Pharmaceutical Research and Manufactures of America
Department of Veterans Affairs has the fallowing R&D areas
Clinical science, Health, Lab, Rehab
Traceability Matrix is ______?
Used to ascertain validated states
A prisoner representative include
Current or former prisoner
Prison Chaplin
Prison Social Worker
Regulation 21 CFR 303.212 is cited as ____.
Title, Part, Section
Section of CRF that deals with the Protection of human subjects in clinical trials is _____?
Section 50
Protocol deviation is an example of Non-Compliance
True or False
True
Regulation which apply to research involving pregnant women and fetuses as subjects referred to _____.
DHHS 46 subpart B
ICH has _____Country Regions and _____Parties
3 and 6
AE which is medically significant but not immediately life-threatening; hospitalizations /prolonged / disabling
Is scale grading _____?
Grade 3
Consent can be obtained on an outdated form
True or false
False
