SOCRA self study

Question 1

Risk management principles are effectively utilized in __________.

a) finance
b) occupational safety
c) insurance
d) all of the above

Answer 1

d) all of the above

Issue 80

Question 2

______________ consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to hazards.

a) Risk management
b) Risk control
c) Risk reduction
d) Risk assessment

Answer 2

d) Risk assessment

Issue 80

Question 3

The purpose of ________ is to reduce the risk to an acceptable level.

a) Risk management
b) Risk control
c) Risk reduction
d) Risk assessment

Answer 3

b) Risk control

Issue 80

Question 4

___________ can be a formal decision to accept the residual risk or it can be a passive decision in which residual risks are not specified.

a) Risk acceptance
b) Risk control
c) Risk reduction
d) Risk assessment

Answer 4

a) Risk acceptance

Issue 80

Question 5

The degree of rigor and formality of quality risk management should reflect available knowledge and does not need to be commensurate with the complexity and/or criticality of the issue to be addressed.

true
false

Answer 5

false

Issue 80

Question 6

__________ is a systematic use of information to identify hazards referring to the risk question or problem description.

a) Risk management
b) Risk identification
c) Risk reduction
d) Risk assessment

Answer 6

b) Risk identification

Issue 80

Question 7

Quality risk management activities are always undertaken by interdisciplinary teams.

true
false

Answer 7

false

Issue 80

Question 8

_____________ is the sharing of information about risk and risk management between the decision makers and others.

a) Risk management
b) Risk identification
c) Risk communication
d) Risk assessment

Answer 8

c) Risk communication

Issue 80

Question 9

The implementation of risk reduction measures can introduce new risks into the system or decrease the significance of other existing risks.

true
false

Answer 9

false

Issue 80

Question 10

Quality risk management is a systematic process for all of the following except ___________.

a) assessment of risks
b) control of risks
c) review of benefits
d) communication of risks

Answer 10

c) review of benefits

Issue 80

Question 11

FMEA stands for _____________________.

a) Failure Mode Effects Administration
b) Failure Mode Effects Analysis
c) Failure Mode Effectiveness Analysis
d) Failure Management Effects Analysis

Answer 11

b) Failure Mode Effects Analysis

Issue 81

Question 12

______________ is most commonly used early in the development of a project when there is little information on design details or operating procedures; thus, it will often be a precursor to further studies.

a) Preliminary hazard analysis
b) Hazard operability analysis
c) Hazard analysis
d) Risk ranking and filtering

Answer 12

a) Preliminary hazard analysis

Issue 81

Question 13

___________ is not an example of principal statistical tools commonly used in pharmaceutical industry.

a) acceptance control charts
b) process capability analysis
c) histologies
d) design or experiments

Answer 13

c. histologies

Issue 81

Question 14

Risk ranking and filtering can be used to prioritize manufacturing sites for inspection/audit by regulators or industry.

true
false

Answer 14

true

Issue 81

Question 15

___________ is a systematic, proactive, and preventive tool for assuring product quality, reliability, and safety.

a) hazard analysis and critical control points
b) hazard operability analysis
c) preliminary hazard analysis
d) fault tree analysis

Answer 15

a) hazard analysis and critical control points

Issue 81

Question 16

Hazard analysis and critical control points might be used to identify and manage the benefits associated with physical, chemical, and biological hazards.

true
false

Answer 16

false

Issue 81

Question 17

The _____________ tool evaluates system (or sub-system) failures one at a time but can combine multiple causes of failure by identifying causal chains.

a) false tree analysis
b) fault tree analysis
c) fault tree association
d) none of the aforementioned

Answer 17

b) fault tree analysis

Issue 81

Question 18

___________ is not a technique to structure risk management by organizing data and facilitating decision making.

a) process mapping
b) check sheets
c) flowcharts
d) cause and effectiveness diagrams

Answer 18

d) cause and effectiveness diagrams

Issue 81

Question 19

To define the frequency and scope of audits, both internal and external, ___________ would not be a factor.

a) existing legal requirements
b) complexity of the site
c) complexity of the delivery process
d) complexity of the manufacturing process

Answer 19

c) complexity of the delivery process

Issue 81

Question 20

______________ is based on a theory that assumes that risk events are caused by deviations from the design or operating intentions.

a) preliminary hazard analysis
b) risk and rank filtering
c) hazard operability analysis
d) fault tree analysis

Answer 20

c) hazard operability analysis

Issue 81

Question 21

Clinical trials are not designed to demonstrate the effectiveness of a treatment in a random sample of the general population.

true
false

Answer 21

true

Issue 82

Question 22

For the purposes of this guidance, the term ‘enrichment’ is defined as the prospective use of any patient characteristic to select a study population in which detection of a drug effect is more likely than it would be in an unselected population

true
false

Answer 22

true

Issue 82

Question 23

__________ is not one of the three broad categories for enrichment strategies.

a) strategies to decrease heterogeneity
b) prognostic enrichment strategies
c) strategies to increase heterogeneity
d) predictive enrichment strategies

Answer 23

c) strategies to increase heterogeneity

Issue 82

Question 24

_______ is choosing patients more likely to respond to the drug treatment than other patients with the condition being treated.

a) predictive enrichment strategies
b) prognostic enrichment strategies
c) strategies to decrease heterogeneity
d) all of the above

Answer 24

a) predictive enrichment strategies

Issue 82

Question 25

Prognostic enrichment does increase the relative risk reduction (e.g., percent of responders or percent improvement in a symptom), but will increase the absolute effect size, generally allowing for a smaller sample size.

true
false

Answer 25

false

Issue 82

Question 26

Of the following, __________ is not a generally accepted way to decrease heterogeneity:

a) decreasing intra-patient variability by enrolling only patients who give consistent baseline values
b) excluding patients taking drugs that are pharmacologically similar to, or that could interact with, the study drug
c) excluding patients likely to tolerate the drug
d) excluding patients who are likely to drop out for non-medical reasons

Answer 26

c) excluding patients likely to tolerate the drug

Issue 82

Question 27

In the ___________ about one third of the screened patients were not randomized because of self-reported poor compliance.

a) VA Cooperative hypertension studies
b) Physicians’ Health Study
c) Gail model
d) NSABP P-1

Answer 27

b) Physicians’ Heath Study

Issue 82

Question 28

Choosing patients with a greater likelihood of having a disease-related endpoint event is an example of ____________.

a) strategies to decrease heterogeneity
b) prognostic enrichment strategies
c) strategies to increase heterogeneity
d) all of the above

Answer 28

b) prognostic enrichment strategies

Issue 82

Question 29

When considering use of an enrichment design, it is not important to consider whether the enrichment strategy can be used in practice to identify the patients to whom the drug should be given and whether the drug might be useful in a broader population than will be studied.

true
false

Answer 29

false

Issue 82

Question 30

BLAs stand for ________.

a) biometrics license applications
b) biologics legislation applications
c) biologics license applications
d) biologics license associations

Answer 30

c) biologics license applications

Issue 82

Question 31

Identifying a responder population and studying this population in a clinical trial can provide ____________.

a) increased study efficiency or feasibility
b) an enhanced benefit-risk relationship for the people in the subset compared to the overall population
c) both of the above
d) none of the above

Answer 31

c) both of the above

Issue 83

Question 32

Identification of a responder population can enhance the benefit-risk relationship of a drug by avoiding exposure and potential toxicity in people who can benefit from the drug.

true
false

Answer 32

false

Issue 83

Question 33

_________ are not a predictive enrichment strategy category.

a) empiric strategies
b) genomic strategies
c) randomized withdrawal studies
d) studies in responders

Answer 33

d) studies in responders

Issue 83

Question 34

In ______, patients who have an apparent response to treatment in an open label period or in the treatment arm of a randomized trial are randomized to continued drug treatment or placebo.

a) empiric strategies
b) genomic strategies
c) randomized withdrawal studies
d) studies in nonresponders

Answer 34

c) randomized withdrawal studies

Issue 83

Question 35

______ involve selection of likely responders based on the patient’s individual physiology or on assessment of disease pathophysiology that suggests that only certain patient subgroups will respond to a particular therapy or that certain subgroups will respond better than others.

a) empiric strategies
b) genomic strategies
c) randomized withdrawal studies
d) pathophysiological strategies

Answer 35

d) pathophysiological strategies

Issue 83

Question 36

With an empiric strategy, the selection of likely responders for a study is based on any understanding of the basis for differences in response between patients, but on observations of a response during screening periods, or prior experiences with the drug or related drugs.

true
false

Answer 36

false

Issue 83

Question 37

By randomizing patients to different doses, the ___________ can also be used to obtain long-term dose-response data.

a) empiric design
b) genomic design
c) randomized withdrawal design
d) pathophysiological design

Answer 37

c) randomized withdrawal design

Issue 83

Question 38

The _________ design can also be used as an initial trial to show effectiveness when there is an existing population of patients in an open-label treatment setting.

a) empiric
b) genomic
c) randomized withdrawal
d) pathophysiological

Answer 38

c) randomized withdrawal

Issue 83

Question 39

Identification of a high treatment response population greatly increases the chance that a study of an effective drug will be able to detect a treatment effect and allows a study to succeed with a smaller sample size than a study in an unselected population.

true
false

Answer 39

true

Issue 83

Question 40

__________ is not a drug that was listed in studies for non-responders.

a) Captopril
b) Rofecoxib
c) Trastuzumab
d) Clozapine

Answer 40

c) Trastuzumab

Issue 83

Question 41

If a selection criterion does not accurately distinguish patients, the effect of enrichment is not weakened.

true
false

Answer 41

false

Issue 84

Question 42

The decision to use an enrichment design is largely left to the sponsor of the investigation, but like the entire research and clinical communities, the __________ is very interested in targeting treatments to the people who can benefit them.

a) Division of Drug Information
b) Food and Drug Administration
c) Center for Drug Evaluation and Research
d) all of the above

Answer 42

b) Food and Drug Administration

Issue 84

Question 43

An enrichment design should be explicitly described in the protocol and study report and should fully detail the enrichment maneuvers and their impact on interpretation of results.

true
false

Answer 43

true

Issue 84

Question 44

Knowing that a drug is effective in patients who have not responded to, or who have responded inadequately to other therapy, is an important clinical finding.

true
false

Answer 44

true

Issue 84

Question 45

The use of enrichment designs will often have implications for labeling, especially in the _______ sections.

a) indications and usage
b) dosage and administration
c) clinical studies
d) all of the above

Answer 45

d) all of the above

Issue 84

Question 46

In general, then, FDA is prepared to approve drugs studied primarily or even solely in enriched populations and will seek to ensure truthful labeling that does not overstate either the likelihood of a response or the predictiveness of the enrichment factor.

true
false

Answer 46

true

Issue 84

Question 47

Any use of an enrichment design should be explicit in the protocol and study report and should fully detail all of the following except for the ____________.

a) specific enrichment maneuvers
b) rationale
c) possible adverse events
d) impact of interpretation of results

Answer 47

c) possible adverse events

Issue 84

Question 48

In some enrichment designs that enroll patients both with and without the enrichment characteristic, the type-II error rate for the study can be shared between a test conducted using only the enriched subpopulation and a test conducted using the entire population.

true
false

Answer 48

false

Issue 84

Question 49

A critical question in all settings in which enrichment is used is therefore the extent to which the enrichment marker-negative population should be studied, an issue that may bear importantly on how a drug would be labeled.

true
false

Answer 49

true

Issue 84

Question 50

A study that uses a marker-_______ only population will provide no direct information about the marker-_______population.

a) negative - positive
b) negative - negative
c) positive - positive
d) positive - negative

Answer 50

d) positive - negative

Issue 84

Question 51

Which of the following documents pertaining to clinical research ethics was amended in 2008?

a) Nuremberg Code
b) Declaration of Helsinki
c) Belmont Report
d) none of the above

Answer 51

b) Declaration of Helsinki

http: //socra.wcea.education/searchOnlineTraining#/training/133162

Question 52

In accordance with the U.S. FDA IDE Regulation (21 CFR Part 812), the investigator shall report all of the following to the sponsor and the reviewing IRB/IEC within 5 working days except:

a) a deviation from the investigational plan to protect the life or physical well being of a subject in an emergency
b) withdrawal of IRB/IEC approval
c) an unanticipated adverse device effect
d) use of an investigational device without obtaining informed consent

Answer 52

c) an unanticipated adverse device effect

http: //socra.wcea.education/searchOnlineTraining#/training/133162

Question 53

An investigational agent is under study that is intended for the treatment of subjects with uncontrolled hypertension. The study is intended to determine short-term side effects, risks, and efficacy. The study is an example of what phase of a trial?

a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4

Answer 53

b) Phase 2

http: //socra.wcea.education/searchOnlineTraining#/training/133162