Vocabulary

Question 1

OHRP

Answer 1

Office for Human Research Protections

Question 2

ADR

Answer 2

Adverse Drug Reaction

Question 3

HHS

Answer 3

Department of Health and Human Services

Question 4

IND

Answer 4

Investigational New Drug

Question 5

IDE

Answer 5

Investigational Device Exemption

Question 6

ICH

Answer 6

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Question 7

WHO

Answer 7

World Health Organization

Question 8

AE

Answer 8

Adverse Event

Question 9

SOPs

Answer 9

Standard Operating Procedures

Question 10

CRF

Answer 10

Case Report Form
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial.

Question 11

Comparator (Product)

Answer 11

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial

Question 12

CRO

Answer 12

Contract Research Organization
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one of more of a sponsor’s trial-related duties and functions

Question 13

IDMC

Answer 13

Independent Data Monitoring Committee
E.g., data and safety monitoring board, monitoring committee

Question 14

DSMB

Answer 14

Data and Safety Monitoring Board

Question 15

IEC

Answer 15

Independent Ethics Committee

Question 16

QA

Answer 16

Quality Assurance

Question 17

QC

Answer 17

Quality Control

Question 18

GMP

Answer 18

Good Manufacturing Practice

Question 19

SDV

Answer 19

Source Data Verification

Question 20

SDR

Answer 20

Source Data Review

Question 21

SPOOS

Answer 21

Significant payments of other sorts

Question 22

PMA

Answer 22

Premarketing approval application

Question 23

CAPA

Answer 23

Corrective and preventative action

Question 24

PK

Answer 24

Pharmacokinetic

Question 25

PD

Answer 25

pharacodynamics