List of Abbreviations

Question 1

AE

Answer 1

Adverse Event

Question 2

CDC

Answer 2

Centers of Disease Control and Prevention

Question 3

CFR

Answer 3

Code of Federal Regulations

Question 4

CIOMS

Answer 4

Council for International Organizations of Medical Sciences

Question 5

CLIA

Answer 5

Clinical Laboratory Improvement Amendments

Question 6

CRF

Answer 6

Case Report Form

Question 7

CT

Answer 7

Chlamydia trachomatis

Question 8

DHHS

Answer 8

U.S Department of Health and Human Services

Question 9

DMID

Answer 9

Division of Microbiology and Infectious Diseases, NIAID, NIH, DHHS

Question 10

FDA

Answer 10

U.S Food and Drug Administration

Question 11

FWA

Answer 11

Federalwide Assurance

Question 12

GCP

Answer 12

Good Clinical Practice

Question 13

HCP

Answer 13

Health Care Provider

Question 14

ICF

Answer 14

Informed Consent Form

Question 15

ICH

Answer 15

International Conference on Harmonisation

Question 16

IDE

Answer 16

Investigational Device Exemption

Question 17

IEC

Answer 17

Independent or Institutional Ethics Committee

Question 18

IRB

Answer 18

Institutional Review Board

Question 19

MOP

Answer 19

Manual of Procedures

Question 20

N

Answer 20

Number (typically refers to subjects)

Question 21

NAAT

Answer 21

Nucleic Acid Amplification Test

Question 22

NG

Answer 22

Neisseria gonorrhoeae

Question 23

NIAID

Answer 23

National Institute of Allergy and Infectious Diseases, NIH, DHHS

Question 24

NIH

Answer 24

National Institutes of Health

Question 25

OCRA

Answer 25

Office of Clinical Research Affairs, DMID, NIAID, NIH, DHHS

Question 26

OHRP

Answer 26

Office for Human Research Protections

Question 27

ORA

Answer 27

Office of Regulatory Affairs, DMID, NIAID, NIH, DHHS

Question 28

PCR

Answer 28

Polymerase Chain Reaction

Question 29

PHI

Answer 29

Personally Identifiable Information

Question 30

PI

Answer 30

Principal Investigator

Question 31

PIS

Answer 31

Patient Infected Status

Question 32

POC

Answer 32

Point-of-care

Question 33

PRN

Answer 33

“As needed”

Question 34

SAE

Answer 34

Serious Adverse Event

Question 35

SDCC

Answer 35

Statistical and Data Coordinating Center

Question 36

SOC

Answer 36

Standard of Care

Question 37

SOP

Answer 37

Standard Operating Procedure

Question 38

STI

Answer 38

Sexually Transmitted Infection

Question 39

TV

Answer 39

Trichomonas vaginalis

Question 40

UADE

Answer 40

Unanticipated Adverse Device Effect