1
Q
The “Common Rule” is the term given to which of the following:
A
45 CFR 46
2
Q
Define No Observable Adverse Effect Level (NOAEL) and describe its importance AND how it is determined
A
No Observable Adverse Effect Level: Dose at which there is no observable adverse effect. The dose is used to determine the dose used in human studies.
3
Q
How would someone determine if OHRP had jurisdiction over a clinical trial?
A
When an institution conducts 1) Studies funded by any agency of the Department of Health and Human Services; OR 2) Studies are conducted by any employee or the Department of Health and Human Services; OR 3) Any human research study and has an assurance agreement with OHRP
4
Q
___________ are used to “flesh out” laws and have the force of the law behind them.
A
Regulations
5
Q
Which of the following regulations apply to OHRP Regulated Studies?
A
45 CFR 46
6
Q
Which of the following groups is NOT considered a vulnerable population?
A. Pregnant Women
B. Employees of the Sponsor
C. Men over 65 years old
D. Children
A
C. Men over 65 years old
7
Q
The Declaration of Helsinki…
A
an ethics document written after the thalidomide tragedy
8
Q
The Pure Food and Drug Act…
A
the first national law regulating drugs
9
Q
The Federal Food Drug and Cosmetic Act…
A
written following the elixir tragedy, this statute required drugs be proven safe prior to marketing in the US.
10
Q
The Durham Humphrey Amendment….
A
This defined over-the-counter products and prescription drugs
11
Q
The Kefauver Harris Act….
A
written after the thalidomide tragedy, this statute provides the basis for the current new drug application
12
Q
What form is the FDA form that lists an investigator’s responsibilities for drug trials?
A
FDA Form 1572
13
Q
What types of studies are acceptable to be conducted in a prison population? Give two examples.
A
Research (involving no more than minimal risk or inconvenience) on the possible causes, effects, and processes of incarceration and criminal behavior.
Minimal risk research on prisons as institutions or prisoners as incarcerated persons.
Research on particular conditions that affect prisoners as a class.
Research on practices likely to benefit the prisoner subject (46.306(a) (2)(a) - 46.306(a)(2)(d)).
14
Q
Which phase of drug development generally has the fewest number of subjects?
A
Phase I
15
Q
It is the responsibility of the investigator to _______________________.
A
Maintain adequate study records
16
Q
The sponsor of a trial is _____________.
A
a person or company that initiates the clinical investigation
17
Q
What are the three main missions of the FDA?
A
To promote and protect the public health by helping safe and effective products reach the market in a timely way
To monitor products for continued safety after they are in use
To help the public get the accurate, science based information needed to improve health.
18
Q
To determine if a child is capable of giving assent the IRB considers ________________.
A
Age, maturity, and phycological state
19
Q
A company’s employees are often considered a vulnerable group. Define vulnerable group AND discuss the ethical concerns when employees are asked to participate in a clinical trial.
A
Potential subjects that are likely to be vulnerable to coercion or undue influence
Employees are at risk because they may feel they have to participate to keep their jobs, gain promotion or receive pay raises.
20
Q
Preclinical trials ___________.
A
include carcinogenesis testing in cell culture
21
Q
When is one parent’s signature for permission of his/her child to participate sufficient?
A
When there is less than minimal risk or a slight increase over minimal risk but with a direct prospect of benefit.
22
Q
The FDA regulation for commercial drugs that governs the informed consent process is:
A
21 CFR 50
23
Q
What does CDER stand for and what are they responsible for?
A
Center for Drug Evaluation and Research (CDER) – Oversight of new drugs
24
Q
What does HIPAA stand for?
A
Health Insurance Portability and Accountability Act
25
The Tuskegee Syphilis Study illustrates the need for strict regulation of clinical trials. List three unethical practices that occurred during the Tuskegee Syphilis study.
Lack of consent
Not told it was research
Not told about other treatments
Not told they were sick
Treatment withheld
26
When an institution loses it assurance agreement with OHRP, then __________.
all clinical trials at this institution are suspended
27
Which of the following is the responsibility of the principal investigator?
A. To obtain IRB approval for the trial protocol prior to enrolling subjects
B. When conducting and IND trial, to read and understand the investigator's brochure
C. To ensure that all aspects of the trial will be carried out in accordance with federal regulations
D. All of the above
D. All of the above
28
Discuss the four categories of pediatric studies and how categorization of a pediatric study impacts permission.
1. Not greater than minimal risk-46.404 - Permission by one parent is sufficient if IRB approved
2. Greater than minimal risk/prospect of direct benefit-46.405 - Permission of one parent sufficient if approved
3. Greater/No direct benefit/Yield knowledge-46.406 - Provision for assent and both parents permission
4. Otherwise not approvable/welfare of children-46.407 - FDA Approval and Permission of Both Parents
29
Who is the FDA Commissioner?
Dr. Marty Makary
30
What does the acronym ADME refer to with regard to pre-clinical testing of a new drug?
Absorption
Distribution
Metabolism
Excretion
31
Discuss prisoners as a vulnerable group AND relate concerns of this group to the Nuremberg Trial and Nuremberg Code.
Prisoner: individual that is involuntarily confined or detained in prison
Ethical Concerns: incarceration may make it difficult or impossible for prisoners to give voluntary informed consent; Coercion-parole, reduced sentence, better living conditions; Can confidentiality be maintained?
People in Nazi concentration camps were essentially prisoners who were forced to participate against their will. The Nuremberg code came as a results of the Nuremberg Trials against Nazi Doctors to require Consent/Voluntary participation.
32
What are the three historic documents that current Good Clinical Practices are based upon?
Declaration of Helsinki
Belmont Report
Nuremberg Code
33
Dr. Smith is interested in an approved drug indicated to prevent asthma. There is some data to show that if this drug is used at a high dose increases cognitive abilities in the elderly. He would like to study the drug in early stage Alzheimer’s patients. His Study Coordinator instructs him that he does not need to file an IND. Is this True or False?
True
Reasoning: If this is just for research purposes no IND is needed
34
When (what year) was ICH started?
A. 1990
B. 1974
C. 1987
D. 1995
A. 1990
35
_________________ was the first statute/amendment that required disclosure of ingredients.
a. The Durham Humphrey Amendment
b. The Pure Food and Drug Act
c. The Federal Food, Drug, and Cosmetic Act
d. None of the above
B. The Pure Food and Drug Act
36
What are the three main points of the Belmont Report?
Respect for persons
Beneficence
Justice
37
The first time a drug is given to a human subject occurs during ___________.
a. phase 3 trials
b. phase 1 trials
c. phase 2 trials
d. preclinical trials
B. Phase 1 Trials
38
Pre-clinical toxicology data ________________.
a. is found in the investigator’s brochure
b. is used to determine the human dose in Phase I trials
c. is used to determine target organs of the chemical
d. all of the above
D. All of the above
39
When an IRB terminates research approval, which of the following must be notified?
a. Study Monitor
b. Regulatory Authorities
c. CRO
d. QA auditor
B. Regulatory Authorities
40
The CFR section that covers investigational new drugs is _____________.
a. 21CFR50
b. 21CFR56
c. 21CFR312
d. 21CFR314
C. 21 CFR 312
41
What two companies did the FDA enlist to help with the Gaucher's Disease issue?
Shire and Protalix
42
______________________________ represent regulatory standards for the marketing of non-prescription drug products not covered by NDAs. The standards provide conditions for some OTC drugs including active ingredients, labeling, and other general requirements.
OTC Monograph
43
An IND submission contains all of the following EXCEPT __________.
a. manufacturing information
b. previous human experience if available
c. clinical protocols and investigator information
d. proposed labeling for the marketed product
D. Proposed labeling for the marketed product
44
Name three actions that the IRB has the authority to take when making a decision about a research project.
Approval
Approval pending changes requested
Rejection (Do Not Approve)
**A.A.R acronym**
45
What is a clinical hold? Discuss two reasons that the FDA may impose a clinical hold for a Phase 3 study.
-Delay the initiation of an early phase trial on the basis of information submitted in the IND
Subjects are/would be exposed to an unreasonable and significant risk of illness or injury
Investigators are not qualified
IB is misleading, erroneous, or incomplete
IND does not contain sufficient information to assess risks
Protocol/Study design is insufficient
46
__________________ is a marketing application used for approval of a generic drug.
a. NDA
b. IDE
c. IND
d. abbreviated NDA
D. Abbreviated NDA
47
All of the following are correct regarding IRB's except:
a. The IRB must have both genders represented.
b. Full board review must occur at an IRB meeting when a quorum of members is present.
c. Expedited review can be used when a sponsor’s deadline for the initiation of a study will pass before the IRB meets.
d. The IRB must have both a non-scientific member and a scientific member.
c. Expedited review can be used when a sponsor’s deadline for the initiation of a study will pass before the IRB meets.
48
When can an expedited IRB review happen?
When the research is no more than minimum risk in human subjects
49
Which of the following documents must have IRB approval?
a. investigator’s brochure
b. draft protocol
c. informed consent
d. all of the above
C. Informed consent
50
What is a letter of authorization? Explain why this is important to an investigator who is submitting an investigator-initiated IND?
Is an authorization that the manufacturer is allowing the FDA to refer to their IND/IDE or marketing application in providing the technical information supporting the proposed clinical investigation. A sponsor-investigator submitting an IND/IDE not subject to a manufacturer’s IND is ordinarily required to submit all technical information, unless such information is referenced from scientific literature.
51
An Investigator is trying to determine severity of an adverse event. An adverse event with discomfort sufficient to reduce or affect normal daily activity would be classified as ____________.
a. Serious
b. Severe
c. Mild
d. Moderate
D. Moderate
52
Which of the following is a serious adverse event?
a. Diarrhea
b. Birth defect
c. Cancer
d. Broken Leg
B. Birth Defect
53
Explain the differences between a treatment IND, emergency use IND, commercial IND, and investigator-initiated IND.
-Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR312.
-Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.
-An Investigator Initiated IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.
-Commercial IND-an IND filed by the sponsor to collect safety and efficacy data on the investigational drug in order to get an NDA approved so that the drug can be marketed (or commercialized) in the US.
54
The IRB is reviewing a clinical trial study involving an investigational new drug to treat acute blood loss due to acute trauma. Potential subjects entering the ER would be given the investigational drug to replace blood lost due to hemorrhage. Discuss two issues that the IRB should discuss while reviewing this trial.
Can the subjects be consented in an emergency situation?
They also need to understand this is investigational and not approved.
55
What does the FDA require on the label of an investigational drug? THIS NEEDS TO BE VERBATUM
"Caution: New Drug-Limited by Federal (or United States) law to investigational use."
56
When do you need to break the blind for a subject?
a. When subject drops off the study and discontinues treatment
b. When treatment for an AE depends the treatment the subject received
c. When pre-approved by the IRB
d. Any time a subject experiences a severe adverse event
B. When treatment for an AE depends on the treatment the subject received
57
List Three of the Five things that determine when is a study exempt from requiring an IND?
-Not intended to support a new indication or any significant change in labeling
-Not intended to significantly change advertising of a drug
-Route of administration or dosage level or use in a patient population or other factor does not significantly increase the risks or decrease the acceptability of the risks.
-The investigation is conducted in compliance with the IRB set forth in part 56 and meet the requirements of informed consent set forth in part 50.
-The investigation is conducted in compliance with Sec 312.7-Promotion and Charging for an IND-ie. promoting that the IND is safe and effective
58
Explain the Reporting Requirements (Timings) of the Sponsor to the Regulatory Authority (FDA) for the following:
A. An Unanticipated Device Effect on a medical device study
B. A Serious and Unexpected AE on a Drug Study
C. An Unexpected and Life Threatening AE that results in Death
A - 10 Days
B - 15 Days
C - 7 Days
59
Which type of clinical data is separated from the rest of the data in a New Drug Application (NDA)?
a. phase 3 data
b. phase 2 data
c. pharmacokinetics and bioavailability
d. none of the above
C. Pharmacokinetics and bioavailability
60
When the FDA approves an NDA, they are approving _________________.
a. the investigator’s brochure.
b. the drug for use for any indication.
c. the drug labeling.
d. the study design.
C. The drug labeling
61
An Investigator is trying to determine expectedness of an adverse event. Where should he look for assistance?
a. Investigator’s Brochure
b. Study Protocol
c. Informed Consent
d. None of the above
A. Investigator's Brochure
62
A(n) ____________ is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease or laboratory/physiological observations?
A. Adverse event
b. side effect
c. pre-existing condition
d. adverse reaction
A. adverse event
63
You are working at a company that is developing a new drug. To be allowed to sell this drug in the United States, the company must _______________.
a. file a PMA with the FDA.
b. file an NDA with the FDA.
c. file a 510(K) with the FDA.
d. file a IND with the FDA.
B. File and NDA with the FDA
64
What does CDER stand for and what are they responsible for?
Center for Drug Evaluation and Research (CDER) – Oversight of new drugs
65
The FDA has a legal right to inspect IRBs and generally does so on a ___ year cycle.
a. 1 to 2
b. 2 to 4
c. 5 to 7
d. 7 to 9
C. 5 to 7
66
The IRB can terminate a study if ___________. a. if data submitted to the FDA is found to be inaccurate
b. if a new consent form is reviewed and approved
c. if new adverse toxicity data becomes available after the review process
d. if the subjects are exposed to risk by participating
C. If new adverse toxicity data becomes available
67
Name at least four elements required in the general investigational plan of an original IND application.
Rationale
Indication
General approach in evaluating drug
Plan for the year
Estimated number of patients
Anticipated risks
68
What is the minimum frequency an IRB should do continuing review of clinical trials they have previously approved?
a. 120 days
b. 90 days
c. 12 months
d. 24 months
C. 12 months
69
Which of the following is NOT an adverse event?
a. Pregnancy
b. Headache
c. Cancer
d. Heart Attack
A. Pregnancy
70
List 4 of the 5 Categories of Serious Adverse Events
-Death or a life threatening AE
-Inpatient hospitalization or prolongation of hospitalization
-A persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions
-A congenital anomaly/Birth Defect
-Is medically important/requires intervention (The “catch all” for SAEs determined by the investigator)
71
The sponsor must file an IND annual report within __________ of the anniversary date that the IND went into effect.
a. 90
b. 120
c. 60
d. 30
C. 60
72
What are the two different kinds of IRBs and how are they different?
Institutional/Hospitals/University IRBs - review and approve research for their site only
Central IRBs - Can review and approve over multiple sites for an entire study
73
After approval of a new drug application, the sponsor ___________.
a. has met all of their regulatory obligations to the FDA.
b. provides periodic adverse drug experience reports to the FDA.
c. provides an bi-annual report to the FDA.
d. has completed all clinical trials for the drug.
B. Provides periodic adverse drug experience reports to the FDA.
74
Explain the difference between a treatment IND, emergency use IND, and investigator-initiated IND.
Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR312.
Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.
An Investigator Initiated IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.
Commercial IND-an IND filed by the sponsor to collect safety and efficacy data on the investigational drug in order to get an NDA approved so that the drug can be marketed (or commercialized) in the US.
75
List 3 of the 5 things that determine when is a study exempt from requiring an IND?
Not intended to support a new indication or any significant change in labeling
Not intended to significantly change advertising of a drug
Route of administration or dosage level or use in a patient population or other factor does not significantly increase the risks or decrease the acceptability of the risks.
The investigation is conducted in compliance with the IRB set forth in part 56 and meet the requirements of informed consent set forth in part 50.
The investigation is conducted in compliance with Sec 312.7-Promotion and Charging for an IND-ie. promoting that the IND is safe and effective
SOCRA 2026
flashcards
Decks in class (16)
# Cards
-
The Nuremberg Code17
-
The Belmont Report24
-
The Declaration of Helsinki7
-
ICH Harmonized Guideline for Good Clinical Practice, E6(R3)24
-
21 CFR Part 111
-
IND Reporting Timelines27
-
IDE Reporting Timelines22
-
Practice Questions23
-
Part 46, Industry GCP, and ICH Reporting Timelines16
-
Study Guide171
-
Regulatory Guide75
-
General Knowledge51
-
Practice Test107
-
Informed Consent15
-
FDA Forms8
-
Title 21 Definitions16
