Definitions

Question 1

Is filed with the FDA when the Sponsor considers that there is sufficient information to meet the regulatory requirements for approval of a drug

Answer 1

New Drug Application (NDA)

Question 2

Used by the Sponsor to notify the FDA and all participating investigators of any AEs associated with the use of a drug that are BOTH serious and unexpected (serious but expected do not require reporting)

Answer 2

IND Safety Report

Question 3

FDA inspection triggered by allegations that raise concerns regarding data integrity or the rights, welfare and safety of study subjects have been compromised

Answer 3

“For cause” inspection

Question 4

Designates an activity designed to test a
hypothesis, permit conclusions to be drawn, and develop or contribute to generalizable knowledge. Is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

Answer 4

Research

Question 5

A study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject

Answer 5

Significant Risk (SR) study

Question 6

The disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended.

Answer 6

Indication for Use

Question 7

An independent group who conducts periodic review and evaluates study data for patient safety, study conduct and progress – will have initiated “event triggers” prior to study start

Answer 7

Data Safety Monitoring Board

Question 8

FDA inspection triggered by submission of an NDA (NME, pivotal studies not conducted in US, only foreign data).

Answer 8

“Routine” inspection

Question 9

Used in clinical research to minimize potential subconscious bias in evaluating treatment response, i.e. – efficacy and safety outcomes

Answer 9

Blinding

Question 10

Name this ethical principle:
Individuals should be treated as autonomous agents capable of deliberation about personal goals. Persons with diminished autonomy are entitled to extensive protection.

Answer 10

Respect (for persons)

Question 11

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article, including any component, part, or accessory which is:
- Recognized in the official National Formulary, or the United States pharmacopeia, or any supplement to them
- Intended for use in the diagnosis of disease or conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals
- Intended to affect the structure or any function of the body of man or other animals

Answer 11

Medical Device

Question 12

An adverse reaction that is both serious and unexpected

Answer 12

Serious and Unexpected Suspected Adverse
Reaction (SUSAR)

Question 13

According to ClinicalTrials.gov, generally include interventional studies (with one or more arms) of FDA-regulated drug, biological, or device products that meet one of the following conditions:
- The trial has one or more sites in the US
- The trial is conducted under an FDA IND or IDE
- The trial involves a drug, biological, or device product that is manufactured in the US or its territories and is exported for research

Answer 13

Applicable Clinical Trial (ACT)

Question 14

The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical
devices, in effect, a private license
granting the applicant (or owner) permission to market the device

Answer 14

Pre-market approval (PMA)

Question 15

Purpose is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights, safety and welfare of humans participating as subjects in the research

Answer 15

Institutional Review Board (IRB)

Question 16

Conceals the identity of the administered product from one or more participants in a study. Usually extends to all parties except as required to package and label study supplies or in case of medical emergency.

Answer 16

Blinding

Question 17

One of the post-market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products

Answer 17

Medical Device Reporting (MDR)

Question 18

An order issued by the FDA to the
Sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation

Answer 18

Clinical Hold

Question 19

An AE or adverse reaction that is not identified in nature, severity, or frequency in the current Investigator’s Brochure (requires reporting)

Answer 19

Unexpected adverse event or adverse reaction

Question 20

Name this ethical principle:
Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their wellbeing.

Answer 20

Beneficence

Question 21

Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device IF that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), OR any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects

Answer 21

Unanticipated adverse device effect

Question 22

Attributable, legible, contemporaneous original, accurate and complete

Answer 22

ALCOA-C

Question 23

Periodic site visits by a clinical research associate (CRA), conducted in-person

Answer 23

On-site Monitoring

Question 24

Any experience that suggests a significant
hazard, contraindication, side effect or
precaution. Important medical events may be considered serious (medical and scientific judgment exercised).

Answer 24

Serious adverse event (SAE)

Question 25

MedWatch FDA form for VOLUNTARY reporting of adverse events, product problems and product use/medication errors (AEs) for use by health professionals or consumers

Answer 25

Form FDA 3500

Question 26

An AE for which a causal relationship to the investigational product is at least a reasonable possibility, i.e. – a causal relationship can not be ruled out.

Answer 26

Suspected adverse reaction

Question 27

Form used for clinical investigators who have NO disclosable financial interests in or arrangements with the Sponsor of the covered clinical study.

Answer 27

Form FDA 3454 Certification

Question 28

MedWatch FDA form for MANUAL reporting of adverse events, product problems and product use/medication errors (AEs) for use by health professionals ONLY

Answer 28

Form FDA 3500A

Question 29

What are the three basic principles outlined in the Belmont Report?

Answer 29

Respect (for persons) Beneficence Justice

Question 30

A potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Answer 30

Early/Expanded Access

Question 31

A study of a device that does not meet significant risk criteria

Answer 31

Non-Significant Risk (NSR) study

Question 32

An appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, has the authority to approve, require modifications in, or disapprove research

Answer 32

Institutional Review Board (IRB)

Question 33

The mechanism the Sponsor uses to submit documents to the FDA, e.g. protocols, reports, correspondence for a medical device

Answer 33

Investigational Device Exemption (IDE)

Question 34

The project director/principal investigator and any other person, whether faculty, staff, or student and regardless of title or position, who is responsible for the design, conduct, or reporting of research, or proposal for funding, including persons who are subcontractors, collaborators, or consultants.

Answer 34

Investigator

Question 35

Role provides medical expertise and oversite to ensure clinical integrity and safety accountability, and responds to subject safety and trial management (e.g., inclusion and exclusion criteria, unblinding procedure)

Answer 35

Medical Monitor

Question 36

Form for clinical investigators who have participated in financial arrangements or holds financial interests that are required to be disclosed. The form should include an attachment with detailed information about the financial interests and arrangements and a description of the steps taken to minimize potential for bias.

Answer 36

Form FDA 3455 Disclosure

Question 37

When approved, permits a device to be shipped lawfully for the purpose of conducting investigations of the device

Answer 37

Investigational Device Exemption (IDE)

Question 38

Name this ethical principle: Fairness in distribution of burdens and benefits: - To each person an equal share - To each person according to individual need - To each person according to individual effort - To each person according to societal contribution - To each person according to merit

Answer 38

Justice

Question 39

In terms of Financial Disclosure, _______ means only a listed or identified investigator or sub-investigator who is directly involved in the treatment or evaluation of research subjects – having a significant role in the study. This definition also includes the spouse and each dependent child of such an investigator or sub-investigator.

Answer 39

Clinical Investigator

Question 40

Refers to interventions that are designed solely to enhance the well-being of an individual patient or client that has a reasonable expectation of success. The purpose is to provide diagnosis, preventive treatment or therapy to particular individuals.

Answer 40

Practice

Question 41

Any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Answer 41

Adverse event (AE)

Question 42

The general purpose of a medical device or its function; encompasses the indications for use.

Answer 42

Intended Use

Question 43

Used in clinical trials to avoid subconscious bias in assigning subjects to treatment

Answer 43

Randomization

Question 44

The clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data.

Answer 44

Real-world evidence (RWE)

Question 45

The data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.

Answer 45

Real-world data (RWD)