Acronyms

Question 1

ADR

Answer 1

Adverse Drug Reaction

Question 2

AEs

Answer 2

Adverse Events

Question 3

ALCOA

Answer 3

Attributable, Legible, Contemporaneous, Original, Accurate

Question 4

BIMO

Answer 4

Bioresearch Monitoring

Question 5

BLA

Answer 5

Biologics License Application

Question 6

CAPA

Answer 6

Corrective Action/Preventive Action

Question 7

CBC

Answer 7

Complete Blood Count

Question 8

CBER

Answer 8

Center for Biologics Evaluation and Research

Question 9

CDA

Answer 9

Confidential Disclosure Agreement

Question 10

CDER

Answer 10

Center for Drug Evaluation and Research

Question 11

CDRH

Answer 11

Center for Devices and Radiological Health

Question 12

CDSCO

Answer 12

Central Drug Standard Control Organization

Question 13

CFR

Answer 13

Code of Federal Regulations

Question 14

cGMP

Answer 14

Current Good Manufacturing Practices

Question 15

cGTP

Answer 15

Current Good Tissue Practice

Question 16

CIOMS

Answer 16

Council for International Organizations of Medical Sciences

Question 17

CMS

Answer 17

Centers for Medicare and Medicaid Services

Question 18

CoC

Answer 18

Certificate of Confidentiality

Question 19

CPT

Answer 19

Current Procedure Terminology

Question 20

CRA

Answer 20

Clinical Research Associate

Question 21

CQMP

Answer 21

Clinical Quality Management Plan

Question 22

CRFs

Answer 22

Case Report Forms

Question 23

CRO

Answer 23

Clinical Research Organization

Question 24

CV

Answer 24

Curriculum Vitae

Question 25

DBT

Answer 25

Department of Biotechnology

Question 26

DCC

Answer 26

Drug Consultative Committee

Question 27

DMAC

Answer 27

Drugs Medical Advisory Committee

Question 28

DOJ

Answer 28

Department of Justice

Question 29

DSMB

Answer 29

Data Safety Monitoring Board

Question 30

DTAB

Answer 30

Drugs Technical Advisory Board

Question 31

EC

Answer 31

Ethics Committee

Question 32

eCRF

Answer 32

Electronic Case Report Form

Question 33

EDC

Answer 33

Electronic Data Capture System

Question 34

EHR

Answer 34

Electronic Health Record

Question 35

EKG

Answer 35

Electrocardiogram

Question 36

EMA

Answer 36

European Medicines Agency

Question 37

ePHI

Answer 37

Electronic Protected Health Information

Question 38

ESCs

Answer 38

Embryonic Stem Cells

Question 39

EU

Answer 39

European Union

Question 40

FDA

Answer 40

US Food and Drug Administration

Question 41

FIH

Answer 41

First In Human

Question 42

Form FDA 1572

Answer 42

Statement of the Inspection

Question 43

Form FDA 482

Answer 43

Notice of Inspection

Question 44

Form FDA 483

Answer 44

Statement of Observation

Question 45

FWA

Answer 45

Federal Wide Assurance

Question 46

GCP

Answer 46

Good Clinical Practice

Question 47

HCT/P

Answer 47

Human Cell Tissue/Products

Question 48

hESC

Answer 48

Human Embryonic Stem Cells

Question 49

HHS

Answer 49

US Department of Health and Human Services

Question 50

HIPAA

Answer 50

Health Insurance Portability and Accountability Act

Question 51

HIV

Answer 51

Human Immunodeficiency Virus

Question 52

IB

Answer 52

Investigator Brochure

Question 53

ICD

Answer 53

Informed Consent Document

Question 54

ICFs

Answer 54

Informed Consent Forms

Question 55

ICH

Answer 55

International Conference of Harmonisation

Question 56

IDE

Answer 56

Investigational Device Exemption

Question 57

IEC

Answer 57

Independent Ethics Committee

Question 58

IND

Answer 58

Investigational New Drug

Question 59

IP

Answer 59

Intellectual Property

Question 60

iPSC

Answer 60

Induced Pluripotent Stem Cells

Question 61

IRB

Answer 61

Institutional Review Board

Question 62

IV

Answer 62

Intravenous

Question 63

LAR

Answer 63

Legally Authorized Representative

Question 64

LCD

Answer 64

Local Coverage Determination

Question 65

MDUFA

Answer 65

Medical Device User Fee and Modernization Act

Question 66

MOHFW

Answer 66

Ministry of Health & Family Welfare

Question 67

MRI

Answer 67

Magnetic Resonance Imaging

Question 68

MTP

Answer 68

Medical Termination of Pregnancy

Question 69

NABH

Answer 69

National Accreditation Board for Hospitals and Health Care Providers

Question 70

NAI

Answer 70

No action Indicated

Question 71

NCD

Answer 71

National Coverage Determination

Question 72

NCI

Answer 72

National Cancer Institute

Question 73

NDA

Answer 73

New Drug Application

Question 74

NGSCR

Answer 74

National Guidelines for Stem Cell Research

Question 75

NIDPOE

Answer 75

Notice of Initiation of Disqualification Proceedings and Opportunity to Explain

Question 76

NIH

Answer 76

National Institutes of Health

Question 77

NSR

Answer 77

NonSignificant Risk

Question 78

OAI

Answer 78

Official Action Indicated

Question 79

OCP

Answer 79

Office of Combination Products

Question 80

OCR

Answer 80

Office for Civil Rights

Question 81

OHRP

Answer 81

Office of Human Research Protection

Question 82

OIG

Answer 82

Office of the Inspector General

Question 83

PHI

Answer 83

Protected Health Information

Question 84

PHS

Answer 84

Public Health Service

Question 85

PI

Answer 85

Principle Investigator

Question 86

PIS

Answer 86

Patient Information Sheet

Question 87

PMA

Answer 87

Premarket Approval

Question 88

PMOA

Answer 88

Primary Mode of Action

Question 89

QA

Answer 89

Quality Assurance

Question 90

QC

Answer 90

Quality Control

Question 91

RA

Answer 91

Rheumatoid Arthritis

Question 92

RBM

Answer 92

Risk-Based Monitoring

Question 93

RCA

Answer 93

Root Cause Analysis

Question 94

SADR

Answer 94

Serious Adverse Drug Reactions

Question 95

SAEs

Answer 95

Serious Adverse Events

Question 96

SE

Answer 96

Schedule of Events

Question 97

SOC

Answer 97

Standard of Care

Question 98

SOP

Answer 98

Standard Operating Procedure

Question 99

SR

Answer 99

Significant Risk

Question 100

SSC

Answer 100

Somatic Stem Cells

Question 101

URL

Answer 101

Uniform Resource Locator

Question 102

VAI

Answer 102

Voluntary Action Indicated

Question 103

WHO

Answer 103

World Health Organization