Socra Exam

Front 1

Investigators do not need to submit an IND if these conditions are met when using an approved product in context of clinical studies.

Back 1

Data not used to support a new indication, labeling or change in advertising.

Research does not involve route, dosage, or study population that significantly increases the risks of the drug products.

Research conducted in compliance with IRB review and ICF requirements

Research is conducted in compliance with requirements for promotion or sale.

(CITI GCP Training)

Front 2

True/False:
If an investigator is participating in drug or biologic studies subject to IND regulations MUST sign Form 1572

Back 2

TRUE

(CITI GCP Training)

Front 3

Using a marketed product for a off-label indication does not require the submission of an IND or IDE if what is true?

Back 3

The intent is the "practice of medicine."

(CITI GCP Training)

Front 4

What is a medical device?

Back 4

Any health care product that does not achieve its primary intended purpose by a chemical interaction or by being metabolized. Medical devices include surgical lasers, sutures, pacemakers, and diagnostic aids such as reagents and test kits for in vitro diagnosis.

(CITI GCP Training)

Front 5

What does IDE stand for?

Back 5

Investigational Device Exemption

(CITI GCP Training)

Front 6

What is a Significant Risk (SR) device?

Back 6

A significant risk device presents a potential for serious risk to the health, safety, or welfare of the subject and it:

Is intended to be implanted into a human;

Is used in supporting or sustaining human life;

Is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise prevents impairment of human health;

OR

Otherwise presents serious risk to health, safety, and welfare of a subject

(CITI GCP training)

Front 7

Name at least 2 agencies that require clinical trials be "registered" on a research site such as ClinicalTrials.go and/or the WHO International Clinical Trails Registry Platform

Back 7

National Institutes of Health (for funded studies)
Various journals
FDA (for studies it oversees)
(FCR loc282)

Front 8

What information do clinical trial registry lists provide at a minimum about a registered clinical trial?

Back 8

information about the study population, intervention, and control, response variables, and key elements of study design.

Many also provide links to the actual protocol.
(FCR loc282)

Front 9

What are some of the seven criteria considered essential to the ethical conduct of clinical research, according to Emanual et al.

Back 9

Value
Scientific validity
Fair selection of participants
Favorable benefit/risk balance
Independent review
Informed consent
Respect for Participants

(FCR loc432)

Front 10

TRUE or FALSE:
Although the outcome of a trial is uncertain, the primary response should always be one where either benefit or noninferiority is potentially achievable

Back 10

TRUE; Example, it is not ethical to study harmful effects of smoking by giving cigerettes to nonsmokers and making them smoke them.

(FCR loc463)

Front 11

According to ICH guidelines, who is responsible for obtaining a statement from the IRB/IEC that it is "organized and operates according to GCP and the applicable laws and regulations"?

Back 11

The sponsor oftentimes obtains this directly from the IRB but may request that the investigator obtain the statement from the IRB and forward it to the sponsor.
(ICH section 5.11; CITI GCP training)

Front 12

Which is guidelines, ICH or FDA, have broader requirements concerning notice to subject about potential access to identifiable research records by third parties?

Back 12

ICH 4.8.10(n) states that the informed consent should indicate that "the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such access."
ICH 5.15.2 states that "the sponsor should verify that each subject has consented, in writing, to direct access to his/her original medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection."
The FDA regulations (50.25(a)(5)) state only that in seeking informed consent, the following information shall be provided to each subject: "(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records."

Front 13

To insure ICH compliance, what signature line should be added to the informed consent form that only complies with FDA rules?

Back 13

In addition to a line for the subject or subject's legally acceptable representative, there should also be a signature and date line for the person who is obtaining informed consent (ie led the informed consent discussion/education). This does not have to be the investigator him or herself.


ICH 4.8.8 states that "prior to a subject's participation in the trial, the written informed consent form should be signed and personally dated by the subject or by the subject's legally acceptable representative, and by the person who conducted the informed consent discussion."
The FDA regulations (50.27(a)) only require the signature of the subject and the date the subject signed the consent form.

Front 14

What is the ICH definition of "impartial witness?"

Back 14

The ICH definition of "impartial witness", found at section 1.26, is, "A person who is independent of the trial, who cannot be unfairly influenced by people involved in the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject."

The FDA does NOT require that the witness be impartial.

Front 15

What device studies need to be performed under an IDE?

Back 15

Only Significant Risk (SR) Device Investigations need to have an IDE. Nonsignificant risk devices (NSR) investigations do not need to be performed under an IDE. The investigator and IRB make the initial risk determination, subject to approval by the FDA.

(Citi training)

21 CRF 812.2(b)

Front 16

What is the equivanlent of an EAE or AE in a device study?

Back 16

UADE - Unanticipated adverse device effects. Must be submitted to FDA within 10 working days after sponsor receives notice of the effect.

Front 17

What is GCP?

Back 17

Good clinical practice (GCP) is defined in ICH E6 as a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, 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 trial subjects are protected.

(CITI training; ICH E6)

Front 18

When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA?
a) Marketing plan (that is, annual updated projection of sales and profits)
b) IND renewal application
c) IND report
d) Adverse Event Summary Report, but only from unblinded portions of studies ("open-label IND safety report"

Back 18

c) IND report

Front 19

Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND?
a) The study is not intended to be reported to FDA to support a new indication or support a labeling change.
b) The study intends to involve more than 100 patients in a study.
c) The study intends to invoke an exception from informed consent.
d) The study involves a route of administration that significantly increases the risks to the patient.

Back 19

a) The study is not intended to be reported to FDA to support a new indication or support a labeling change.

Front 20

Who is responsible for making the initial risk determination for a device being used in a study?

Back 20

The sponsor-investigator

Front 21

What is the purpose of Form FDA 1572

Back 21

Statement of Investigator - legally binding contract with the FDA that attests that the investigator has read the Investigator's Brochure and agrees to conduct the study according to the protocol and FDA regulations.

(CITI Training; Form FDA 1572)

Front 22

When is deviation from a protocol allowed?

Back 22

When deviation is necessary to eliminate an immediate hazard to one or more subjects.

(CITI Training; ICH E6 Section 4.5)

Front 23

When must the investigator update the IRB about the progress of a trial?

Back 23

During the conduct of the study and at termination.

(CITI Training)

Front 24

What is a Humanitarian Use Device (HUD) ?

Back 24

Humanitarian Use Device (HUD) means a device that is intended to benefit patients in the treatment or diagnosis of a disease or condition affecting fewer than 4,000 individuals in the U.S. per year.

(CITI Training)

Front 25

What are medical device classifications (from the FDA) based on for regulatory purposes?

Back 25

Level of control needed to ensure their safety and effectiveness. There is also a classification of level of risk, either significant or non-significant.

(CITI Training)

Front 26

What is a 510(k) device?

Back 26

Device to be marketed is substantially equivalent to a legally marketed similar device and has demonstrated that it is as safe and effective as the legally marketed device. Includes all Class II devices, and Class I devices that are not exempt.

Front 27

What is clinical equipose?

Back 27

The presence of uncertainty as to the benefits or harm from an intervention among the expert medical community , rather than in the individual investigator, is a justification for a clinical trial. Some have maintained that until an intervention has been proven beneficial, randomization is the most ethical approach and one that will provide the correct answer soonest.

(FCR loc497)

Front 28

In terms of control groups, what is "usual therapy?"

Back 28

Rather than the best available treatment option, it is the one considered the standard of care in the community. The most efficacious treatment may have limitations that make its widespread use unlikely and unavailable, due to cost, competently trained clinicians to administer, lack of acceptance by the practicing clinical community, socioeconomic and cultural differences or other factors. Particularly an ethical concern when conducting trials in areas where the best treatment is not available.
(FCR loc508)

Front 29

True or false: When conducting a trial, having a placebo control design that withholds beneficial treatment may be ethical if it is for conditions causing only mild to moderate discomfort.

Back 29

True but depends on the case. IRB or IEC committees help determine the ethics of this approach.

(FCR loc519)

Front 30

What is the difference between an observational clinical trial and an experimental clinical trial?

Back 30

Non-experimental (observational) - Investigator observes the relationship between treatment and outcome using patients whose treatment status is determined by MDs caring for those patients.

Experimental (intervention study, RCT) - Investigator assigns treatment status for the primary reason of assessing the scientific question at hand.

Front 31

What are the limitations of a case-controlled study?

Back 31

Accuracy of exposure time (what time period to look at)
Recollections are probably less accurate after passage of time, especially about things such as lifestyle and family history (things not necessarily in the medical records.)

Potential for bias.