final

Question 1

what year saw the passage of the food and drugs act of 1906 prohibiting interstate commerce of misbranded or altered foos, drugs, and drink

Answer 1

1906

Question 2

what does the privacy rule issued in 2000 establised standards for in the context of health information?

Answer 2

protection of individuals health information

Question 3

in 1906 upton siclairs novel “ the jungle” led to the passage if which important legislation related to food and drug safety?

Answer 3

Meat inspection Act

Question 4

the belmont report issued in 1979 identifies three basic ethical principles for the protection of human research subjects. What are these principles?

Answer 4

respect for persons, beneficence, and justice

Question 5

what legislation enacted in 2007 mandates registration and results reporting of applicable clinical trials on clinicaltrials.gov?

Answer 5

Food and Drug Administration Amendments act

Question 6

1962 Faced with the devastating effects of physicians prescribing untested thalidomide as well as other informal drug testing practices congress passed the Kefauver-Harris Amendment to the Food, Drug and Cosmetic act.What did this amendment require?

Answer 6

required manufactures to provide proof of efficacy(effectivness) and greater proof of safty before marketing a new drug

Question 7

what is the main purpose of the declaration of Helsinki establised in 1964?

Answer 7

worldwide recommendations to guide physicians conducting biomedical research involving human subjects

Question 8

Durring the nuremberg trial 1- principles known as the Nurembeg code became the prototype for

Answer 8

ethical research standards for human subjects research

Question 9

which tragic icident in 1937 emphasized the need for assuring drug safety before marketing tleading to the food and drug and cosmetic act of 1938

Answer 9

sulfanilamide tradgedy

Question 10

which event propted the passage of the biologics control act of 1902 giving regulatory power over antitoxins and vaccines?

Answer 10

the death of 13 children who received diphtheria antitoxin

Question 11

what is another word for the risk factor whose effect is being studied?

Answer 11

exposure

Question 12

an expirimental research studies that compare the effectivness of medical treatments can also be refered to as

Answer 12

an interventional study

Question 13

in studies where the outcome of intrest has already occured and the data are collected eithier from records or by asking participants to recal exposures is called a ____ study

Answer 13

retrospective

Question 14

in which type of study is the researcher aware of the outcome and works backward to investigate potential causes?

Answer 14

retrospective

Question 15

what is a measurable attribute that varies across study units for example individual participants in a study?

Answer 15

variable

Question 16

True/False
An intervetional study is by definition a prospective study

Answer 16

true

Question 17

analytic studiesare studies that

Answer 17

attempt to test a hypothesis and establish relationships between variables

Question 18

a prospective study

Question 19

Unanticipated problems that aare serious adverse events should be reported to the IRB within ___ ot the invvestigator becoming aware of the event

Answer 19

1 week

Question 20

true/false
the regulations state that an IRB may be made up entirely of members from a single profession

Answer 20

false

Question 21

by the definition of vulnerable by the ICH guideline for good clinical practice does not include

Answer 21

women

Question 22

IRBs reveiw research protocols to confirm that

Answer 22

appropriate sfeguards are in place for vulnerable subjects

there will be proper application of informed consent

there will be protection of subject privacy

Question 23

which federal agency ini the united states is responsible for the regulations governing IRbs?

Answer 23

Food and Drug Administration(FDA)

Question 24

what is the primary purpose of IRBs in clinical research?

Answer 24

to ensure participant safety and ethical conduct

Question 25

roles of the IRB in reveiwing informed consent

Answer 25

to ensure that it does not include exculpatory laguage im[lying that subjects waives any rights or releases the investegator instituion from liability for negligence

to ensure the language is understandable to target population

to determine whether it accuratly includes and describes all elements requiered by the regulations

Question 26

independent institutional reveiw boards do not

Answer 26

have to be geographically close to the location od the instition of the primary investigator

Question 27

the research study must be approved by the IRB but an exception can be made to the requierment for all subjects to give informed consent before study enrollment and treatment. this is refered to as

Answer 27

exception for documentation of informed consent for emergency research

Question 28

what is the role of the IRB when vulnerable subjects are to be enrolled?

Answer 28

the IRB will determine if adequate safeguards are in place to provide protection

Question 29

True/False
the principle investigator may delegate many research related tasks to members of the study staff

Answer 29

True

Question 30

___ exists when someone has an intrest that may comprimise their ability to remain objective and impartial.

Answer 30

A conflict of interest

Question 31

True/False
If the princliple investigator delegates study enrollment to the clinical research cordinator then the coordinator assumes responsibility for maintaining integrity in the study proticol adherence

Answer 31

false

Question 32

true/false
a conflict of intrest are always based on financial gain

Answer 32

false

Question 33

____ must be listed in the investigator agreement or in section 6 on the Form FDA 1572 as individuals who will assist the PI in the conduct of the clinical trial

Answer 33

subinvestigators

Question 34

which proffessional is responsible for designing the statistical analysis plan for a clinical trial?

Answer 34

biostatistician

Question 35

what describes the assumption that there is not one better intervention present (for withier the control or expirimental group) during the design of a randomized control trial?

Answer 35

Clinical equipoise

Question 36

what are the primary responsibilities of a clinical research coordinator?

Answer 36

pateint recuitemt and enrollment

reglatory complience

Question 37

which proffessional is responsible for ensuring that a clinical trial complies with regulatory guidlines and ethical standards?

Answer 37

Principal investigator PI

Question 38

what additional needs will the PI provide?

Answer 38

workspace for the clinical research coordinator

computer and internet acess

storage space