Definitions Flashcards
Permission to examine, analyze, verify, & reproduce any records and reports important to a trial
direct access
comparator
product or placebo used in an investigation
LAR
legally authorized representative (for a patient)
What is a short form
document that states the elements of the informed consent have been presented orally to and understood by participant or LAR
short form consent, oral presentation, and summary are examples of what?
components
when are components used?
-when a non-English translated IC is not available
-when window of treatment is short
Data & safety monitoring plan
a plan that is used to ensure the safety of subjects
A group of experts that review research data to ensure subject safety & data validity
Data safety monitoring committee
What is blinding?
Method where personnel involved in a trial are intentionally prevented from knowing the treatment arms/treatment assignment to patients
Which blinding type: sponsor, PI/staff & patients are blinded
triple blind
How many types of blinding are there?
4 types
- triple
-double
-single
-open label (none)
single blinding
when only the subjects are blinded
double blinding
PI/staff & subjects are blinded
NIDPOE
Notice of initiation of disqualification proceedings & opportunity to explain
When is a NIDPOE issued by the FDA?
When an investigator may be disqualified due to non-compliance
randomization
method where subjects are randomly assigned into different treatment arms.
cirriculum vitae
Qualifications of the investigator showing education, training, & experience that qualifies them as an expert
CAPA
Corrective & preventative actions
What is CAPA
Process to identify root cause of issues or problems & actions to resolve them
ICH
International Council for Harmonization
HHS
Department of Health and Human Services
The World Medical Association is involved with which foundation?
The Declaration of Helsinki
3 principles of the Belmont Report
- Respect of persons
- Beneficence
- Justice
The 2 expressions of beneficent actions in terms of human trials/ethical principles
- Do not harm
- Maximize possible benefits and minimize possible harms
Biochemical & physiological effects of a drug
Pharmacodynamic
Activity of a drug in the body over time
Pharmacokinetic
Stratification is ___ and an example is ___
Arrangement of classification of something into different groups.
Randomizing men and women separately because a drug may metabolize differently for each gender
Significant risk device
Investigational device that presents a potential for serious risk to the health, safety, or welfare of a subject
A device that does not meet the definition of a significant risk device
Non-significant risk device
Measures believed to quantify the potential effect of a treatment or therapy
Endpoints
Audit’s major purpose
To confirm site is confirming SOPs are being upheld
To oversee sponsor, monitor, investigator & IRB to determine whether all groups meet regulatory responsibilities
Inspection
To ensure that study & procedures are properly documented & verify the integrity of data
To audit
What is indemnification?
The definition of duties and responsibilities of the involved parties in cases of loss or injury linked to a clinical trial
