Clinical Research and Regulatory Terminology Exam
Questions & Answers.
Guidance - Correct Answer Documents published by FDA to provide current
interpretation of regulations.
HAACP - Correct Answer Hazard Analysis and Critical Control Point (inspection
technique)
HCT/P - Correct Answer Human Cells, Tissues and Cellular and Tissue-Based Product
HCFA - Correct Answer Health Care Financing Administration (determines Medicare
payment system); Created in 1977, under DHHS, take care of insurance for 67 million;
insure quality assurance through the Medicaid and Medicare programs. They basically
do whatever they want with our tax dollars to insure the people to worthless to go get a
job.
HDE - Correct Answer Humanitarian Device Exemption: the regulations regarding the
orphan device process for the HDE is codified in 21 CFR 814, Subpart H, and an
approved HDE is subject to the same quality system regulations (QSR), in 21 CFR 820.
OOPD (The Office of Orphan Product Development) is responsible for granting orphan
designation to devices known as humanitarian use devices (HUDs) which must meet
the criteria:
Device treats or diagnoses a disease in fewer than 4,000 US patients a year
No comparable FDA-approved therapy exists for the proposed indication
Evidence is provided that the applicant could not otherwise bring the device to the
market.
HIPAA - Correct Answer Health Insurance Portability and Accountability Act of 1996:
HIPAA protects certain health information. The "Privacy Rule" was issued to protect the
privacy of health information, including healthcare research.
HMO - Correct Answer Health Maintenance Organization: The most common type of
managed care provider. Determines which treatments are covered and the level of
reimbursement.
HUD - Correct Answer Humanitarian Use Device: Similar to compassionate use of a
drug. The device is their last alternative. The device can be used in more than 4000 US
patients per year, no comparable therapy available, the device may not be able to be
marketed with using doing a HUD. Falls under the safe medical device act of 1990
IB - Correct Answer Investigator's Brochure
IC (ICF) - Correct Answer Informed Consent (Form)
,ICH - Correct Answer International Conference on Harmonization: Includes United
States, European Union (EU) and Japan. Began in 1990 with the primary goal of
harmonizing guidance documents. Harmonized Guidance’s allow for one process to be
used for all jurisdictions. Also created the Common Technical Document (CTD).
Reduced the need for duplicate testing.
IDE - Correct Answer Investigational Device Exemption: Waives the requirement of
clearance or approval and allows the Sponsor to distribute the device and conduct
human clinical trials. An IDE allows the sponsor to be exempt from: misbranding,
establishment registration and device listing, camps, records and reports, and cleared
510(k) or approved PMA. IDEs are approved by FDA.
IDMB - Correct Answer Independent Data Monitoring Board
IDSMB - Correct Answer Independent Data Safety Monitoring Board
Import - Correct Answer to be imported into the US a drug product must be the subject
of an approved NDA or comply with the IND regulations. A drug substance intended for
user in the manufacturing, processing or repacking of a new drug may be imported into
the US if it complies with the labeling exemption pertaining to shipments of drug
substances in domestic commerce.
Inactive Ingredient - Correct Answer any drug product component other than the active
ingredient, such as excipients, vehicle and binders.
INAD - Correct Answer Investigational New Animal Drug
IND - Correct Answer Investigational New Drug (application): Claims exemptions from
certain FDA Federal Food, Drug, and Cosmetic Act. Allows for the shipment of
investigational drugs in interstate commerce for the purpose of conducting clinical trials.
Effective 30 days after FDA receives it. INDs are NOT approved, but instead become
effective.
IND Sections - Correct Answer the IND must include:
Form FDA 1571
Table of Contents
Introductory Statements
General Investigational Plan
Investigator's Brochure
Protocol(s)
Study protocol(s)
Investigator data or completed form(s) FDA 1572
Facilities data or completed form(s) FDA 1572
Institutional Review Board data or completed form(s) FDA 1572
Chemistry, Manufacturing, and control Data
Pharmacology and Toxicology data
, Previous human experience
Additional Information
Information Amendment - Correct Answer Includes most submissions under an active
IND, such as new protocols, final study reports, safety reports, CMC information, etc.
The initial IND ends with 000; each serial amendment receives the net consecutive
number.
INN - Correct Answer International Nonproprietary Names
Intended Use - Correct Answer Objective labeled use of a device.
Investigator IND - Correct Answer Protocol and IND submitted by an individual
investigator instead of a manufacturer. A letter of authorization allows FDA to review the
sponsor's DMF or cross reference CMC information. The investigator, not the
manufacturer, is responsible for maintaining the IND.
IRB Responsibilities - Correct Answer Institutional Review Board responsibilities
include: To ensure protection of rights, safety, and well-being of human subjects in
trials; to approve, require modification of, or disapprove trials; to provide public
assurance of protection; to conduct periodic review of biomedical research involving
human subjects.
ISO - Correct Answer International Organization for Standardization
IUO - Correct Answer Investigational Use Only
IVD - Correct Answer in Vitro Diagnostic: are reagents, instruments, and systems
intended for use in diagnosing diseases or other conditions, including a determination of
the state of health, to cure, mitigate, treat or prevent disease. IVDs are intended for use
in collecting, preparing, and examining specimens taken from the human body. They
are considered devices as defined in section 201(h) of the FDA&C Act. They are
covered under separate FDA regulation 21 CFR Part 809, and have their own
label/labeling regulation within section 809.10.
Label - Correct Answer Any display of written, printed or graphic matter on the
immediate container or package of, or affixed to, any article.
Labeling - Correct Answer All written, printed or graphic matter accompanying an article
at any time while such article is in interstate commerce or held for sale after shipment in
interstate commerce; includes user manuals, brochures, advertising, etc.
LDTs - Correct Answer Laboratory developed tests
LOA - Correct Answer Letter of Authorization: A letter from the holder of a Drug Master
File to FDA authorizing a company to reference the DMF also Letter of Agreement).
