3. Sample Questions_Multiple Internet Sources (4) Flashcards
(93 cards)
1
Q
A written description of a trial/study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report. (ICH GCP E6 1.13
A
Clinical Trial/Study Report
2
Q
Any laws and regulations addressing the conduct of clinical trials of investigational products (ICH GCP E6 1.4)
A
Applicable Regulatory Requirements
3
Q
Any public or private entity or agency (including Federal, State or other agencies). The word facility as used in section 520(g) of the Act is deemed to by synonymous with the term institution for purposes of this part.(21 CFR, sec. 50.3)
A
Institution
4
Q
Are devices intended solely for veterinary use exempt form IDE regulations?
A
Yes
5
Q
Define an Implant as per regulatory definitions.
A
A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more.
Refer to 21 CFR, sec. 812.3.
6
Q
Define Class I Device.
A
Low risk devices, examples include bandages, exam gloves, Q-tips.
7
Q
Define Closed System in relation to electronic records.
A
An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system
8
Q
Define Digital Signature.
A
An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.
Refer to 21 CFR, Sec. 11.3.
9
Q
Define ‘efficacy’ in a clinical trial.
A
The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease.
10
Q
Define noninvasive diagnostic device or procedure.
A
One that does NOT 1) penetrate the skin or mucous membranes of the body, ocular cavity or the urethra 2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum or the vagina beyond the cervical os. (21 CFR, sec. 812.3).
11
Q
Define Unanticipated Adverse Device Event.
A
Any serious adverse effect on the health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect or problem, or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application
12
Q
Does the term vulnerable subject include employees under direct supervision of clinical investigator under ICH GCP guidelines?
A
Yes.
13
Q
How long must an IRB retain records according to ICH guidelines?
A
3 years.
14
Q
How long should essential documents be retained after formal discontinuation of clinical development of a product?
A
2 years.
15
Q
How many calendar days does a sponsor have to report a fatal or life-threatening unexpected adverse drug reaction?
A
7 calendar days.
16
Q
In accordance with ICH/GCP E6 (R2), what constitutes a ‘certified copy’?
A
a copy of the original record (irrespective of type of media used) that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information
17
Q
Informed Consent MUST Contain:
A
- explanation of purpose of research
- duration of participation
- description of procedures to be followed
- identification of any procedures which are experimental
- any foreseeable risks or discomfort
- statement about potential benefits to subjects
- statement if no reasonable alternative procedures or treatments are available to subjects
- for > minimal risk, a statement about compensation and if medical treatment is available for injuries
- statement of who to contact in the event of research-related injury
18
Q
The head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated.
A
Department of Agency Head
19
Q
The official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (45 CFR, sec. 46.102).
A
Certfication
20
Q
Waiver of Signed Informed Consent
A
- if the only record linking the subject to the research would be the consent document and the principal risk would result from breach in confidentiality
- the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the context of research
21
Q
What additional elements must informed consent contain?
A
- Risk to embryo or fetus
- Termination procedures
- Costs to study subjects
- Approximate number of study subjects
- Statement of new findings impacting willingness to participate.
22
Q
What are Essential Documents in clinical trials?
A
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
23
Q
What are Nonclinical Studies?
A
Biomedical studies not performed on human subjects.
Defined in ICH GCP E6 1.41.
24
Q
What are the circumstances required for informed consent?
A
- Subject has had sufficient opportunity to consider whether to participate
- The possibility of coercion or undue influence is minimized.
25
What are the informed consent regulations applicable to?
- drugs
- medical devices
- biological products
- electronic products
- food (including dietary supplements and infant formulas)
- color additives
## Footnote
These are referred to as test articles.
26
What are the levels of blinding in clinical trials?
* Single: Subject does not know the treatment group
* Double: Subject and treating clinician/research team do not know the treatment group
* Triple: Subject, treating clinician/research team, and trial monitoring committee do not know the treatment group.
27
What are the requirements for continuing IRB review under the Revised Common Rule (2018)?
Research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year.
28
What change was made to the basic elements of informed consent under the Revised Common Rule (2018)?
addition of an element to provide notice whether participants’ information or biospecimens collected as part of the current research might be stripped of identifiers and used for other research in the future
29
What characterizes a Phase I Clinical Trial?
Small trials with healthy subjects, purpose is to determine pharmacokinetics and maximum tolerated dose.
30
What determines a drug’s safety?
The absence of harmful side effects on the individuals exposed to it so far.
31
What does it mean for a serious adverse event (SAE) to be reported to the FDA?
It must be reported within 15 calendar days if it fits all SAE criteria but is not life-threatening and does not result in death.
32
What does 'Open system' refer to in relation to electronic records?
An environment in which system access is not controlled by persons who are responsible for the content of the electronic records that are on the system
33
What does Termination refer to in clinical trials?
A discontinuance by a sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion.
## Footnote
This is defined in 21 CFR, sec. 812.3.
34
What does the term 'Regulatory Authorities' refer to?
Bodies having the power to regulate. In the ICH GCP guideline that guidelines the expression Regulatory Authorities includes the authorities that review submitted clinical data.
35
What is a Case Report Form (CRF)?
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
A document designed to record all of the protocol required information for each trial subject.
## Footnote
This is defined in ICH GCP E6 1.11.
36
What is a Class I Device?
Low risk, examples include bandages, exam gloves.
37
What is a Class II Device?
Medium risk, examples include powered wheelchairs, infusion pumps, surgical drapes
38
What is a Clinical Trial/Study Report?
A written description of a trial/study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects.
39
What is a Comparator in a clinical trial?
An investigational or marketed product or placebo used as a reference.
40
What is a Contract in the context of clinical trials?
A written, dated and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and if appropriate on financial matters
## Footnote
ICH GCP E6 1.17 defines this.
41
What is a Custom Device?
A device that 1) necessarily deviates from devices generally available 2) is not generally available to Physicians/dentists 3) not generally available in finished form for purchase or dispensing 4) is not offered for commercial distribution through labeling/advertising 5) is intended for use by an individual patient named in the order of the physician or dentist and is made to be in a specific form for that patient.
42
What is a double blind study design?
Both the subject and the Investigator (or site staff) do not know which treatment the subject is receiving.
43
What is a Guardian in clinical research?
An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes research. (21 CFR, sec. 50.3)
## Footnote
Defined in 21 CFR, sec. 50.3.
44
What is a Phase IV Clinical Trial?
Post-marketing, continue assessing therapeutic value and monitor less common adverse events.
## Footnote
This phase occurs after a drug has been approved for use.
45
What is a Protocol Amendment?
A written description of changes to or formal clarification of a protocol.
46
What is a Test Article?
Any food or drug, medical device for human use, human food additive, color additive, or any other article subject to regulation under the act.
47
What is a Translational Device?
A device considered to be a new drug or antibiotic before May 28, 1976.
48
What is an Adverse Drug Reaction (ADR)?
All noxious and unintended responses to a medicinal product related to any dose.
49
What is an Audit Certificate?
A declaration of the confirmation by the auditor that an audit has taken place.
50
What is an Audit Trail?
Documentation that allows reconstruction of the course of events in a clinical trial.
51
What is an Electronic Record?
Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form created, modified, maintained, archived, retrieved or distributed by a computer system.
52
What is an Electronic Signature?
A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding.
53
What is an example of an FDA Advisory Committee? designed by the Food and Drug Administration (FDA) to enhance the drug review and approval process
Oncologic Drugs Advisory Committee.
FDA Advisory Committees are organized by indication
54
What is an IND?
An investigational new drug application, synonymous with 'Notice of Claimed Investigational Exemption for a New Drug.'
## Footnote
Refer to 21 CFR, sec. 312.3.
55
What is an Independent Data Monitoring Committee (IDMC)?
A committee established by the sponsor to assess the progress of a clinical trial, safety data, and critical efficacy endpoints.
## Footnote
ICH GCP E6 1.25 discusses this.
56
What is an Inspection in clinical trials?
The act by a regulatory authority of conducting and official review of documents, facilities, records and any other resources that are deemed by the authorities to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organizations (CROs) facilities, or at other establishments deemed appropriate by the regulatory authorities. (ICH GCP E6 1.29)
57
What is an Interim Clinical Trial/Study Report?
A report of intermediate results and their evaluation based on analyses performed during the course of the trial.
## Footnote
This is defined in ICH GCP E6 1.32.
58
What is Biometrics?
A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable.
## Footnote
Defined in 21 CFR, Sec. 11.3.
59
What is Certification in the context of research involving human subjects?
The official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
60
What is Compliance in clinical trials?
Adherence to all the trial-related requirements, GCP requirements, and applicable regulatory requirements.
## Footnote
Defined in ICH GCP E6 1.15.
61
What is Good Clinical Practice (GCP)?
A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of the trial subjects are protected.
## Footnote
ICH GCP E6 1.24 provides this definition.
62
What is interpretive bias?
A result when blinding methods for a study are not sufficient to prevent conclusions based on a subject’s treatment assignment.
63
What is meant by Direct Access in clinical trials?
Permission to examine, analyze, verify, and reproduce records important to the evaluation of a clinical trial.
64
What is meant by 'Documentation' in clinical trials?
All records, in any form, that describe or record the methods, conduct and or results of a trial, the factors affecting the trial and the actions taken. (ICH GCP E6 1.22)
65
What is Private Information?
- information about behavior which occurs in a context in which an individual can reasonably expect that no observation or recording is taking place
- information which has been provided for a specified purpose by an individual and which the individual can reasonably expect will not be made public (e.g. medical record)
66
What is Quality Assurance (QA) in clinical trials?
All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with Good Clinical Practices and the applicable regulatory requirements
67
What is Quality Control (QC)?
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. Operational techniques and activities undertaken within the quality assurance system to verify quality requirements of trial-related activities.
## Footnote
Defined in ICH GCP E6 1.47.
68
What is the definition of Confidentiality in clinical trials?
Prevention or disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity.
## Footnote
ICH GCP E6 1.16 provides this definition.
69
What is the goal of using blinding methods in clinical trials?
Reduction of bias.
70
What is the jurisdiction of the Food and Drug Administration (FDA)?
Oversight of regulation adherence in clinical trials.
71
What is the purpose of a Phase II Clinical Trial?
Initial demonstration of efficacy in patients, short-term safety information.
72
What is the purpose of a Phase III Clinical Trial?
Use in large numbers of patients, long-term safety.
73
What is the role of a Monitor in clinical trials?
An individual designated by a sponsor or contract research organization to oversee the progress of an investigation.
## Footnote
This is defined in 21 CFR, sec. 812.3.
74
What is the role of Jeff Washington in the CLEAR2 study as a Clinical Trial Manager?
Jeff guides clinical aspects of the trial.
75
When was the Publication of the Common Rule?
1991.
76
What is the timeline for reporting unanticipated adverse device effects to the sponsor and reviewing IRB?
No later than 10 working days after the investigator first learns of the effect.
## Footnote
This is according to 21 CFR 812.150.
77
What must Informed Consent contain?
* Explanation of purpose of research
* Duration of participation
* Description of procedures
* Identification of experimental procedures
* Foreseeable risks.
78
In accordance with ICH/GCP E6 (R2) an individual designated by the investigator/institution should maintain records of investigational product delivered to the trial site. What should these records include?
- Dates and quantities of investigational product delivered to the site
- Inventory at the site
- Use by each trial subject
- Disposition of unused investigational product
- Batch/serial numbers
- Expiration dates
- Unique code numbers assigned to trial subjects and investigational products
## Footnote
This is per ICH/GCP E6 (R2).
79
What should source documents and trial records be according to ICH/GCP E6 (R2)?
Attributable, legible, contemporaneous, original, accurate, and complete.
80
What special population must the IRB pay special attention to?
Vulnerable subjects.
81
What was the purpose of the Belmont Report?
Provide basic ethical principles, boundaries between practice and research.
82
What year was the GCP and HIPAA established?
1996.
83
Where can official government information regarding GCP be found?
US Code of Federal Regulations.
84
Who is responsible for the safety and well-being of all trial subjects?
The IRB.
85
Year of OHRP creation
2000
86
→ An investigational device that 1) is intended as an implant and presents a potential for serious risk to the health, safety or welfare of the subject 2) is purposed or represented to be for a use in supporting or sustaining human life and presents a potential serious risk 3) is for a use of substantial importance in diagnosing, curing , mitigating or treating disease or otherwise preventing impairment of human health. (21 CFR, sec. 812.3)
Significant Risk Device
87
Types of federally-funded research that may be done using prisoners as subjects
- possible causes, effects, and processes of incarceration and criminal behavior
- prisons as institutional structures or prisoners as incarcerated persons
- conditions particularly affecting prisoners
- practices aimed at improving the health or well-being of prisoners
88
A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. (ICH GCP E6 1.18)
Coordinating Committee
89
Publication of FDA Regulations
1980
90
Year of HHS and FDA Revise Regulations
1981
91
Under the revised Common Rule (2018), which of the following would NOT be a required element for broad consent for the storage, maintenance and secondary research use of identifiable private information or identifiable biospecimens
-the approximate number of participants
Would be:
-a general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens
-an explanation of whom to contact for answers to questions about the subject’s rights
-unless the subject will be provided details about specific research studies, a statement that they will not be informed of any specific research studies that might be conducted using their identifiable private information or identifiable biospecimens
92
In accordance with ICH/GCP E6 (R2) an investigator is responsible to ensure adequate resources. Which is part of the investigator’s responsibilities?
-Responsibility to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period
-Responsibility for supervising any individual to whom the investigator delegates trial-related duties and functions conducted at the trial site
-Responsibility to ensure appropriate remuneration of trial-related staff
93
In accordance with ICH/GCP E6 (R2) the sponsor should implement a system to manage quality throughout all the stages of the trial process. The quality management system should use a risk-based approach that includes all of the following:
Critical Process and Data Identification, Risk Identification, Risk Evaluation, Risk Control, Risk Communication, Risk Review, Risk Reporting
