1
Q
Which of the following is a disclosure of financial interest form?
A
FDA Form 3455 (21CFR54)
2
Q
Which of the following is a certification of financial interest form?
A
FDA Form 3454
3
Q
If the investigator did have financial arrangement with the sponsor, they would submit what form?
A
FDA form 3455
4
Q
What is direct access?
A
The permission to analyze, examine, verify, and reproduce any records or reports that are important to the evaluation of a clinical trial.
5
Q
What is 21CFR11
A
Electronic Records and Electronic Signatures
6
Q
What is 21CFR50
A
Protection of Human subjects, Informed consent of human subjects, and additional safeguards for children in clinical investigations
7
Q
What is 21CFR312?
A
Investigational new Drug Application (IND)
8
Q
What is 21CFR812
A
Investigation Device Exemption (IDE)
9
Q
What is 45CFR46?
A
HHS policy for Public Welfare and the Protection of Human subjects
i.e. Pregnant women, human fetuses/neonates in research; Protection of prisoners; protection of children as subjects in research; registration of the IRB (**OHRP)
** Also referred to as the “Common Rule”
** requires that 1 consent form be uploaded per clinical study funded federally or clinically
10
Q
What is 21CFR56
A
Institutional review boards, their Organization & Personnel; Function & Ops; Records and reporting; and Administrative actions for noncompliance
11
Q
What is 42CFR11?
A
Submission of clinical trial information and results for certain clinical trials must be made publicly available via clinicaltrials.gov
a. Register the trial on ClinicalTrials.gov
b. Submit summary results and AE information about the trial to ClinicalTrials.gov
C. Ensure the information about the registered trial was accurately submitted to ClinicalTrials.gov
12
Q
What is a 1571?
A
Cover page of an IND Application. Form submitted by the sponsor to the FDA at the beginning of a drug trial. Contract between the sponsor and FDA
13
Q
What is a 1572?
A
Statement of the investigator (found in 21CFR Part 312) that ensures that the investigator agrees to conduct a study in accordance with protocol, applicable regulations, and to supervise the study. Also supplies information to the sponsor about the investigators qualifications and the clinical site. 1572 and 312 both have 2s
14
Q
What elements are listed in the investigational plan of the IND application
A
a. rationale
b. indication
c. general approach for evaluating drug
d. plan for the year
e. estimated number of patients
f. anticipated risks
15
Q
How long does an investigator have to wait to enroll study patients after an IND is submitted?
A
30 days or if FDA approves sooner in writing
16
Q
What is an investigation or marked product, or placebo, used as a reference in a clinical trial?
A
A comparator
17
Q
How do you define a (NOAEL)? How would you describe its importance and how it is determined?
A
No observable adverse effect level. Typically found in animal and pre-clinical studies. This is the dose at which there is no observable adverse effect. The dose is used to determine the dose used in human studies.
18
Q
What does NOAEL stand for?
A
No Observable Adverse Effect Level
19
Q
After approval of an NDA, the sponsor must continue to?
A
Periodic AE drug experience reports to the FDA
20
Q
Once the sponsor submits an NDA to the FDA, how long does the FDA have to file it for review?
A
60 days
21
Q
What are two different kinds of IRBs and how are they different?
A
a. Institutional IRB: acts as the IRB for a specific site b. Central IRB: acts as a single IRB for multiple sites (> 2 sites)
22
Q
Sponsor must file an IND annual report within how many days of the anniversary date that the IND went into effect?
A
60 days
23
Q
How long must a sponsor and investigator maintain records/reports for a drug study?
A
2 years after a marketing application is approved OR 2 years after shipment and delivery of ID is discontinued and FDA is notified.
24
Q
List categories of an SAE
A
-Death or life threatening
-hospitalization or prolongation
-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)
25
How would someone determine if OHRP had jurisdiction over a clinical trial?
When an institution conducts
1) studies funded by any agency of the Dept. of HHS
OR 2) studies are conducted by any employee or the Dept. of HHS
OR 3) any human research study and has an assurance agreement with OHRP.
26
What is OHRP?
Office of Human Research and Protection
27
What is used to “flesh out” laws and have the force of law behind them
Regulations
28
What are three historic documents that current GCP is based upon?
The Declaration of Helsinki, the Belmont Report, and the Nuremberg Code
29
What year was ICH started?
1990
30
What is ICH?
The International Council for Harmonisation
31
All significant risk devices (SR) must be performed under an IDE. Non-significant Device (NSR) does not need to be performed under IDE.
** NSR only needs approval by IRB
** SR requires IRB and FDA approval
32
A Pre-market Approval (510(K)) is submitted when?
When the new device to be marketed is substantially similar (equivalent) to one already on the market
33
Class I, Class II, and Class III Devices:
A. Class I - lowest risk and subject to general standards only (i.e. tongue depressors, surgical gloves)
B. Class II – moderate risk and are subject to general and FDA standards (i.e. flexible laryngoscopes and surgical drills)
C. Class III – high risk and require premarket approval before being sold. Devices that support/sustain life, are of substantial importance in preventing impairment of health, or present a potential/unreasonable risk of injury/illness (i.e. artificial organs, replacement heart valves, pacemakers)
34
Discuss prisoners as a vulnerable group AND relate concerns of this group to the Nuremberg Trial and Nuremberg Code?
i. Prisoner: individual that is involuntarily confined or detained in prison
ii. Ethical concerns: Incarceration may make it difficult/impossible for prisoners to give voluntary informed consent; coercion-parole, reduced sentence, better living conditions, can confidentiality be maintained?
iii. People in Nazi concentration camps were essentially prisoners who were forced to participate against their will. The Nuremberg code came as a result of the Nuremberg trials against Nazi Doctors to require consent/voluntary participation (they were testing on prisoners without consent)
35
What is an IND?
A request from a sponsor to obtain authorization from the FDA to administer an investigational drug or biological product to humans. Must be submitted to the FDA 30 calendar days before initiating a clinical trial. (Form 1571)
36
What are the 4 types of INDs?
o Investigator IND: initiates/conducts investigation, and under whose immediate direction the investigational drug is administered/dispensed.
o Emergency use IND: allows the FDA to authorize the use of an experimental drug in an emergency situation that does not allow time for submission of an IND.
o Treatment IND: 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.
o Commercial 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 in the US
37
What is an investigator IND?
initiates/conducts investigation, and under whose immediate direction the investigational drug is administered/dispensed.
38
What is an emergency use IND?
initiates/conducts investigation, and under whose immediate direction the investigational drug is administered/dispensed.
39
What is a treatment IND?
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.
40
What is commercial 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 in the US
41
What forewarning is on the investigational drug label?
Caution: New Drug – limited by Federal (or US) law to investigational use”
42
An IND submission contains all of the following?
Manufacturing information, previous human experience if available, and clinical protocols and investigator information
43
If using a marketed drug or biologic, an IND only needs to be submitted if all six conditions are met:
i. not intended to be reported to FDA in support of new individuation for use or to support any significant changes in labeling of drug
ii. Not intended to support a significant change in advertising of product
iii. Does not involve a route of administration/dosage level that significantly increases the risk associated with drug
iv. Conducted in compliance with requirements for IRB review/consent
v. conducted in compliance with requirements concerning promotion/sale of drugs
vi. Does not intend to involve exception from informed consent for emergency research
44
According to the FDA, what is the definition of a drug?
A product that is intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease; that is intended to affect the structure or any function of the body.
45
Name three actions an IRB has authority to take when making a decision about a research project?
Approval, approval pending changes requested, or rejection (do not approve)
46
What is a clinical hold? What are some reasons the FDA may impose a clinical hold for a Phase 3 study?
I. Clinical hold is the delay in the initiation of an early phase trial on the basis of information submitted in the IND
ii. Reasons to impose a clinical hold:
a. subjects are/would be exposed to unreasonable and significant risk of illness or injury
b. investigators are not qualified
c. IB is misleading, erroneous, or incomplete
d. IND does not contain sufficient information to assess risks
e. Protocol/study design is insufficient
47
A sponsor will not ship any drug until they receive the following items?
1. IRB approved protocol, ICF, recruitment materials, IRB approval letter
2. Signed and completed 1572, CV’s, Financial disclosures for everyone listed on 1572
3. Current lab ranges, lab certifications
48
An investigator is trying to determine severity of an AE. An AE with discomfort sufficient to reduce or affect normal daily activity would be classified as?
Moderate
49
Exception from General Informed consent requirements?
Subject confronted with life-threatening situation, consent cannot be obtained because of subject inability to communicate with or obtain consent from the subject, time is not sufficient to obtain consent from legal representative
50
Exception from General Informed consent requirements for Emergency research?
1. Subject confronted with life-threatening situation
2. Consent not feasible because of subject inability due to medical condition
3. Intervention must be administered before ability to obtain consent from LAR
4. No way to identify prospectively the individuals likely to become eligible for participation
5. Participation holds out the prospect of direct benefit to subjects
6. Investigation could not practically be carried out without a waiver
7. Investigational plan defines the length of the potential therapeutic window and attempts have been made to gain consent
51
At least one IRB member needs to have what?
Non-scientific background and no ties to the organization
52
If you don’t have all the information necessary for providing a complete report of an SAE, what should you do?
Report the information known ASAP and then add additional info later.
53
IRB’s must have the following:
a. Both genders are represented
b. Full board review must occur in an IRB meeting when the minimum number of members is present
c. Must have both a non-scientific member and a scientific member
54
What is a marketing application used for the approval of a generic drug?
Abbreviated NDA
55
What is a party who submits a marketing application to the FDA for approval of a drug device or biologic product?
Clinical Investigator
56
What is a letter of authorization?
A letter of authorization is when 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.
57
Explain why is a letter of authorization important to an investigator who is submitting an investigator-initiated IND?
Important to submit this letter with the IND so that the FDA knows there are other studies that are currently being conducted using the same drug but potentially for a different use or patient population.
58
Name things that determine when a study is exempt from requiring an IND:
i. Not intended to support a new indication or any significant change in labeling (dosing)
ii. Not intended to significantly change advertising of a drug (way of administration)
iii. Route of administration or dosage level or use in a patient population or other factor does not significantly increase the risk or decrease the acceptability of the risks
iv. 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
v. The investigation is conducted in compliance with Sec 312.7 – promoting that the IND is safe and effective
59
What is an IDE?
A request that allows the investigational device to be used in a clinical study in order to collect safety and effectiveness of data. Must be submitted by a sponsor for a significant risk device study. IDE Application must demonstrate that there is reason to believe that the risks to human subjects outweigh the anticipated benefits but that the investigation is scientifically sound and reason to believe that the device as proposed for use will be effective.
a. intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.
b. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of the subject.
c. for a use of substantial importance in diagnosing, curing, mitigating, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of the subject.
60
Medwatch Form 3500:
Voluntary reporting of an AE, product use/med errors, product quality problems, and therapeutic failures.
61
Medwatch Form 3500A:
Mandatory reporting of medical device adverse events (IND safety reporting) submitted no later than 15 calendars days (submitted for serious, related, unexpected)
62
Any adverse drug experience that places the patient/subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred” is?
Life-Threatening Drug Adverse Experience
63
What is an adverse drug reaction?
In a preapproved clinical experience, a new medical product or its new usages, particularly at the therapeutic doses, all noxious and unintended responses to a medicinal product related to any dose.
64
What is coercion?
When an overt threat of harm is intentionally presented by one person to another in order to obtain compliance.
65
What does OMB stand for?
FDA forms. Number is located in the top right corner of is the Office of Management and Budget.
66
What is undue influence?
Occurs through an offer of an excessive, unwarranted, inappropriate, or improper reward or other overture in order to obtain compliance.
67
Why was the International Conference of Harmonization (ICH) created?
Allowed for standard definitions and terminology for key aspects of clinical research reporting to follow GCP. Additionally, gives guidance on mechanisms for handling expedited reporting of adverse drug reactions in the investigational phase of drug development.
68
What is an adverse event (adverse experience)?
Any untoward medical occurrence in a patient or subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment (unfavorable/unintended)
69
What is a adverse drug reaction (ADR)?
in pre-approval clinical experiences with a new medicinal product or its new usages, all noxious and unintended responses to a medicinal product related to any dose (causal relationship between product and event with reasonable possibility)
70
What does ADR stand for?
Adverse drug reaction
71
What is an unexpected drug reaction?
an adverse reaction, the nature or severity of which is not consistent with the application product information (i.e. not found in IB)
72
What is a serious adverse event or serious adverse drug reaction?
adverse events that occur if suspected to be medicinal product-related. Might be significant enough to lead to important changes in the way the medicinal product is developed (i.e life-threatening of function)
o *serious is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient’s life or functioning
o Results in death or is life threatening (i.e. inpatient hospitalization, prolongation of existing hospitalization, results in persistent or significant disability/incapability, or is a congenital anomaly/birth defect
73
What is the Pure Food and Drug Act?
The first national law regulating drugs. The first statute/amendment that required disclosure of ingredients.
73
What is expeditedness of an adverse drug reaction?
purpose of expedited reporting is to make regulators, investigators aware of new, important information on serious reactions (i.e. events that have been unobserved or undocumented)
74
What does CDER stand for and what are they responsible for?
The Center for Drug Evaluation and Research and they are responsible for the oversight of new drugs.
75
What does HIPAA stand for?
Health Insurance Portability and Accountability Act
76
The FDA has a right to inspect IRBs and generally does so how often?
5 to 7 year cycle
77
What is the Durham Humphrey Amendment?
This defined OTC products and prescription drugs. Clear criteria was given to what constituted a prescription drug and the circumstance in which it can be dispensed to a patient and outlawed the action of dispensing a prescription to those who did not have an Rx. (Label, Caution: Federal law prohibits dispensing of this medication without a prescription”)
78
The FDA regulation for commercial drugs that governs the informed consent process is:
21 CFR50
79
What is the Kefauver Harris Act?
Written after the thalidomide tragedy, this statute provides the basis for the current new drug application. Sought to guarantee safety, purity, and efficacy of both prescription and non-prescription medicines
80
What is the thalidomide tragedy?
Between 1950 and 1960 Thalidomide was given to pregnant women which resulted in severe birth defects.
81
Any IRB can terminate a study if?
New adverse toxicity data becomes available after the review process
82
What are the four categories of pediatric studies and how categorization of a pediatric study impacts permission?
i. Not greater than minimal risk – permission by one parent is sufficient if IRB approved
ii. Greater than minimal risk/prospect of direct benefit – permission of one parent is sufficient if approved
iii. Greater/No direct benefit/Yield knowledge – provision for assent and both parents’ permission
iv. Otherwise not approvable/welfare of children – FDA-approval and permission of both parents
83
When an institution loses its assurance agreement with the OHRP, then what?
All clinical trials at the institution are suspended.
84
Who is the FDA commissioner?
Dr. Marty Makary
85
If a trial is funded by OHRP funds, what needs to be filed with their office?
A FWA (Federal Wide Assurance)
86
What does the acronym ADME refer to with regard to pre-clinical testing of a new drug?
Absorption, distribution, metabolism, and excretion
** all influence the drug levels and kinetics of drug exposure to the tissues and that is why they also influence the performance and pharmacological activity of the compound as a drug.
87
Pre-clinical toxicology data is?
Found in the investigators brochure; used to determine the human dose in Phase 1 trials; used to determine target organs of the chemical.
88
When an IRB terminates research approval, who must be notified?
Regulatory authorities
89
What two companies did the FDA enlist to help with the Gaucher’s Disease issue?
Shire and Protalix
90
What type of Data is in a New Drug Application (NDA)?
Phase 2 and Phase 3 data
91
When the FDA approves an NDA, they are approving what?
The drug labeling, safety and effectiveness in its proposed uses, methods in manufacturing and quality are adequate to the drug’s identity, strength, quality, and purity
92
What does NDA stand for?
New Drug Application
93
An investigator is trying to determine expectedness of an AE. Where should he look for assistance?
Investigator Brochure
94
You are working at a company that is developing a new drug. To be allowed to sell this drug in the US, the company must what?
File an NDA with the FDA
95
What are three responsibilities of an investigator?
Obtain IRB approval for the trial protocol prior to enrolling subjects, when conducting an IND trial, to read and understand the investigators brochure, and to ensure that all aspects of the trial will be carried out in accordance with federal regulations.
96
What is a person or company that initiates the clinical investigation?
The sponsor
97
What three things does the IRB use to determine if a child is capable of giving assent?
Age, maturity, psychological state
98
What are some unethical principles 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.
99
When is one parent’s signature for permission of his/her child to participate sufficient?
When there is less than minimal risk or a slight increase over minimal risk but with a direct prospect of benefit.
100
Pre-clinical trials…?:
Include carcinogenesis testing in cell culture (In vitro or In Vivo)
101
What are the three main missions of the FDA?
1. To promote/protect the public health by helping safe and effective products reach the market in a timely way
2. To monitor products for continued safety after they are in use
3. To help the public get the accurate, science based information needed to improve health.
102
What is the Federal Food Drug and Cosmetic Act?
Laws that authorize the Food and Drug Administration (FDA) to oversee and regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics. Its introduction was largely influenced by a mass poisoning event in which elixir sulfanilamide, an untested antibiotic containing the toxin diethylene glycol, led to over 100 deaths across 15 states.
103
What is an NCT number?
A unique ID code assigned to each record in Clinicaltrials.gov
104
When must a clinical trial registration be submitted?
No later than 21 calendar days after the first human subject is enrolled
105
By when will the NIH director post clinical trial registration information?
No later than 30 calendars after the responsible party has submitted such information
106
When must clinical trial results be submitted to Clinicaltrials.gov?
No later than 1 year after the primary completion of the applicable clinical trial
107
When must clinical trial information submitted to clinicaltrials.gov be updated or corrected?
Not less than once every 12 months. Smalls changes to study (i.e. study start date, primary completion date, overall recruitment status) must be updated not later than 30 calendar days after any change. IDE not approved by FDA must be updated not later than 15 calendar days after a change
108
What is the first step in adminstering an investigational drug according to 21 CFR 312?
A. Administer drug only under the supervision of a sub-I
B. Ensure all subjects have signed consent
C. Administer drug only to subjects under the investigator's personal supervision
D. Send all drugs back to the sponsor for approval
C
109
How is an investigator defined per FDA regulations?
A. The sponsor of the clinical investigation
B. The individual who conducts the clinical investigation
C. A member of the clinical investigator's team
D. The regulatory body overseeing the investigation
B
110
Within how many months must final reports be submitted to all IRBs for NSR studies?
A. 3 months
B. 6 months
C. 12 months
D. 24 months
B
111
What is the role of a sponsor in clinical trails per 21 CFR 312.3?
A. The regulatory authority approving the drug
B. The individual who reviews trial outcomes
C. The person responsible for initiating the clinical investigation
D. The participant volunteering for trails
C
112
When does subject discontinuation require reporting to the FDA?
A. For all discontinuations
B. When discontinuation is due to an adverse event or serious adverse event
C. Only in case of death
D. Never stated in regulation
B
113
What should be included in the Data Quality Assurance section of a study protocol?
A. Ethical assurance, publication rights, financing
B. Data recording, study monitoring, auditing
C. Investigator responsibilities, informed consent, protocol adherence
D. Subject recruitment, safety reporting, study monitoring
B
114
What is the first component of a quality system?
A. Training
B. Policies/procedures
C. Personnel roles/responsibilities
D. Document managing, record retention, reporting
C
115
What does CAPA stand for in trial management?
A. Corrective and preventative action plan
B. Comprehensive action plan assessment
C. Clinical assessment and planning application
D. Corrective action preventative assessment
A
116
Who is responsible for ensuring investigators comply with GCP requirements?
A. Investigators
B. Sponsors
C. FDA
D. Regulatory authorities
B
117
What is a key responsibility of a sponsor in clinical trials?
A. Conducting the trial personally
B. Selecting qualified investigators
C. Ensuring participant confidentiality
D. Providing financial support to regulators
B
118
What is the purpose of a MEDWATCH form 3500A?
A. Mandatory reporting form for AEs by sponsors, manufactures, etc..
B. voluntary health professional reporting form
C. consumer product complaint form
D. employee health record update form
A
119
What does ICH GCP 5.1.1 dictate regarding SOPs?
A. All staff must be trained annually
B. Investigators are responsible for creating SOPs
C. Sponsors are responsible for implementing and maintaining QA/QC system with written SOPs
D. Regulatory authorities must approve all SOPs
C
120
What are the essential components of an IND application?
A. animal studies, manufacturing details, clinical protocols
B. financial disclosure forms, clinical protocols, investigator resumes
C. drug sourcing information, pharmaceutical formulations, budgetary outlines
D. clinical trial schedules, patient consent forms
A
121
What does the intervention experience need to be compared to, for research in kids with more than minimal risk and no benefit?
A. expected outcomes
B. clinical care
C. previous research studies
D. hypothetical scenarios
B
122
Who must be appointed by the IRB to give consent for study participation of child wards of the state?
A. the child's guardian
B. a government official
C. an advocate appointed by the IRB
D. any willing adult
C
123
What regulations do non-significant risk studies need to adhere to?
A. follow abbreviated IDE regulations, no FDA approval
B. Must have FDA and IRB approval
C. are exempt from all regulations
D. must report to FDA prior to study
A
124
Which is not a type of IND?
A. commercial IND
B. investigator IND
C. patient IND
D. treatment IND
C
125
How often must sponsors submit progress reports in device trails to all reviewing IRBs?
A. monthly
B. quarterly
C. biannually
D. at least yearly
D
126
How soon must a sponsor report to FDA if a drug presents an unreasonable and significant risk to subjects?
A. 10 working days
B. 15 working days
C. 5 working days
D. 20 working day
C
127
What must sponsors provide procedures/instructions on to investigators according to ICH GCP 5.14.3?
A. audit strategies
B. data management
C. handling and storage of investigational products (IP)
D. ethics submission
C
128
What do FDA regulations require for monitor selection?
A. sponsors must select monitors with specific certifications
B. sponsors shall select monitors qualified by training and experience
C. all monitors must have a medical degree
D. monitors must be selected randomly
B
129
Which regulation contains FDA guidelines for IRB related topics?
A. 21 CFR 50
B. 21 CFR 56
C. 21 CFR 312
D. 21 CFR 58
B
130
What does the ICF document represent in clinical research?
A. income and cash flow statement
B. informed consent form
C. internal control framework
D. initial certification form
B
131
What are the elements to be trained for correct us of IP with each subject?
A. correct dosage and timing only
B. proper administration technique only
C. side effect management only
D. correct use including dosage, administration, and side effect management
D
132
which studies require submission of an IDE applications?
a. all clinical device studies
b. device studies not intended for human use
c. studies supporting premarket approval some 510(K) notifications
d. in-vitro diagnostic studies only
c
133
what purpose do essential documents serve in a clinical trials?
a. to ensure participant privacy
b. to permit evaluation of the trial's conduct and data quality
c. to facilitate trial marketing
d. to comply with financial disclosure requirements
b
134
what is the medical device equivalent of an SAE?
a. calibrated device incident
b. unanticipated adverse device effect (UADE)
c. predicted device dyfunction
d. calibrated device effectiveness
b
135
under which guideline section should investigators complete CRFs?
a. FDA 21 CFR part 11
b. ICH GCP guideline section 4.9
c. EU directive 2001/20/EC
d. HIPPA privacy rule
b
136
Which method is NOT used to reduce bias in clinical trials?
a. randomization
b. blinding
c. open label
d. using a placebo control group
c
137
what is one of the six components of the general investigational plan included in FDA progress report for drug studies?
a. estimated number of patients in trail
b. list of subjects who died
c. frequent and most serious adverse events
d. title and protocol number
a
138
what does OAI stand for in FDA inspection classifications?
a. operational audit inquiry
b. overall inspection authority
c. official action indicated
d. operational activity index
c
139
what does IDE stand for in the context of clinical trails?
a. investigational drug exemption
b. innovative device evaluation
c. immediate device examination
d. investigational drug evaluation
a
140
what is part of the individual study information included in FDA progress reports for drug studies?
a. summary of IND safety reports
b. title, protocol number, and purpose
c. rationale for study
d. estimated number of patients in trials
b
141
what does a phase 2 and 3 study protocol need to outline according to the FDA?
a. detailed budget
b. outline of study protocol
c. endorsements
d. insurance policies
b
142
what is the difference in AE reporting between drug and device trails?
a. device trails require more rigorous AE reporting
b. drug trails do not need to record all AEs
c. drug trails record and evaluate all AEs for drug relationship, device trials might not
d. there is no difference in AE reporting
c
143
what is the full form of VAI in context of FDA inspections?
a. voluntary action indicated
b. violation action initiated
c. voluntary audit inquiry
d. voluntary action insignificant
a
144
what defines the concept of 'minimal risk' in research according to 21 CFR 56.102(i)?
a. no risk to subjects
b. minimal financial risk
c. risks not greater than daily
d. only psychological risk
c
145
what constitutes a significant payment requiring financial disclosure?
a. $10,000+
b. $15,000+
c. $20,000+
d. $25,000+
d
146
what FDA inspection classification indicates no objectionable practices were found?
a. OAI
b. VAI
c. NAI
d. CAI
c
147
which of the following is commonly added to protocols by sponsors but not explicitly recommended by ICH GCP?
a. trial objective and purpose
b. data safety monitoring plan
c. selection and withdrawal of subjects
d. statistics
b
148
what is source data verifications?
a. confirming patient eligibility
b. comparing CFR to original source for accuracy
c. reviewing patient feedback
d. ensuring patients have signed the consent form
b
149
what are 3 types of medical device studies listed under IDE regulation?
a. significant risk, non-significant risk, and exempt
b. minor risk, major risk, non-applicable
c. clinical trial, preclinical trial, and post market
d. observational, investigational, and controlled
a
150
to whom must an investigator submit progress reports according to 21 CFR 312?
a. sponsor only
b. IRB only
c. both sponsor and IRB
d. the FDA
c
151
what criteria must be met for children to be involved on greater than minimal risk research with a prospect of benefit?
a. risks are minimal and benefits are unknown
b. risks are justified by the anticipated benefits and assent + consent is obtained
c. only parental consent is required
d. research can proceed without any ethical review
b
152
who ultimately approves an ICF?
a. FDA
b. sponsor
c. IRB
d. principal investigator
c
153
how does the FDA define source data or documents?
a. as digital databases
b. as medical records and case histories
c. as physical samples
d. as laboratory reports
b
154
what factor can necessitate financial disclosure?
a. any payment from the sponsor
b. compensation to PI affected by study outcome
c. travel expenses covered by sponsor
d. any association with sponsor
b
155
who determines whether a device trial is significant risk, non-significant risk or exempt?
a. sponsor/investigator > IRB > FDA
b. FDA alone
c. IRB alone
d. sponsor/investigator alone
a
156
what does the summary information in the FDA progress report for drug studies typically include?
a. rational for the study and estimated number of patients
b. list of subjects who died and subjects who dropped out due to adverse events
c. clinical trials to be conducted in the 1st year
d. none of the above
b
157
how is power of clinical trial typically calculated?
a. using effect size and variability
b. using the number of subjects alone
c. using the type of control group
d. using the study design
a
158
what is the time period within which a sponsor must submit a final report after completion/termination of a SR device trial?
a. within 3 months
b. within 6 months
c. within 9 months
d. within 12 months
b
159
what items should be present in an investigator's brochure?
a. only drug description and formulation
b. pharmacological effects only
c. drug description, pharmacological effects, PK and biological disposition, safety and effectiveness, possible risks and side effects
d. only the PK and biological disposition of drug
c
160
what are an investigator's responsibilities regarding the protocol?
a. develop study protocol, conduct trial per FDA 1572, submit protocol changes
b. report adverse events, protect subjects, obtain informed consent
c. ensure IRB compliance, maintain records, properly train staff
d. ethical assurance, financing assurance, publication rights
b
161
how should an investigator reconcile investigational product received from the sponsor?
a. by ensuring it is used as quickly as possible
b. by returning all unused product immediately
c. by reconciling the received product as per regulations
d. by logging its use in personal diaries
c
162
which document is crucial for a facility to respond to within a specified timeframe to avoid further action from the FDA?
a. a warning letter
b. an establishment inspection report
c. a notice of compliance
d. a certification of approval
a
163
what is required alongside patient or LAR consent according to 21 CFR 50?
a. verbal agreement
b. documentation of informed consent
c. a witness present
d. payment information
b
164
what guidelines describe the essential documents for trial conduct?
a. FDA blue book
b. ICH GCP guideline, section 8
c. ISO 14155
d. E6(R2) Guideline for GCP
b
165
what kind of reports should be included in the attachments to research proposals documented by IRBs?
a. annual financial reports
b. progress reports
c. auditing reports
d. marketing reports
b
166
what types of reports must be made from an investigator to a sponsor?
a. annual financial reports
b. safety occurrences, protocol deviations, progress reports, final report, financial disclosure report
c. SOP updates
d. audit findings
b
167
what regulations must significant risk studies follow?
a. follow all IDE regulations and have FDA approval
b. follow abbreviated IDE regulations
c. need only IRB approval
d. consult with FDA but no formal approval needed
a
168
what must a sponsor do if the FDA requests more information about an IND safety report for drug studies?
A. respond within 7 days
B. respond no more than 15 calendar days from receipt of request
C. ignore the request as it's optional
D. request an extension
b
169
how many activities must IRBs maintain documentation of?
a. 5
b. 7
c. 4
d. 10
b
170
under which FDA regulation are investigators required to keep records of deviations from protocol?
a. 21 CFR 312.64
b. 21 CFR 812.140(a)(4)
c. ICH GCP guideline, section 8
d. 21 CFR 50.25
b
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
