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Acronyms

ACRP: Association of Clinical Research Professionals

ADR: Adverse Drug Reaction

AE: Adverse Event

AMA: American Medical Association

BIMO: Bioresearch Monitoring Program

CCI: Certified Clinical Investigator

CCRC: Certified Clinical Research Coordinator

CCRI: Certified Clinical Research Investigator

CDER: Center for Drug Evaluation and Research

CFR: Code of Federal Regulations

CI: Clinical Investigator

CPGM: Compliance Program Guidance Manual

CRA: Clinical Research Associate

CRC: Clinical Research Coordinator

CRF: Case Report Form

CRO: Clinical Research Organization

CV: Curriculum Vitae

DHHS: Department of Health and Human Services

DIA: Drug Information Association

DGR: Dangerous Goods Regulation

DSMB: Data Safety Monitoring Board

ECG: Electrocardiogram

EDC: Electronic Data Capture

EIR: Established Inspection Report

FDA: Food and Drug Administration

FDAMA: FDA Modernization Act

GCP: Good Clinical Practice

GLP: Good Laboratory Practice

GMP: Good Manufacturing Practices

HAM-A: Hamilton Rating Scale for Anxiety

HIPAA: Health Insurance Portability and Accountability Act

HHS: Health and Human Services

IATA: International Air Transport Association

IB: Investigator's Brochure

IC: Informed Consent

ICH: International Conference on Harmonization

IDE: Investigational Device Exemption

IEC: Independent Ethics Committee

IND: Investigational New Drug application

IRB: Institutional Review Board

IV: Intravenously

LAR: Legally Authorized Representative

NAI: No Action Indicated

NDA: New Drug Application

NIH: National Institutes of Health

NSR: Non-Significant Risk

OAI: Official Action Indicated

OCR: Office of Civil Rights

OHRP: Office for Human Research Protections

OTC: Over-the-Counter

PA: Physician Assistant

PDUFA: Prescription Drug User Fee Act

PhRMA: Pharmaceutical Research and Manufactures of America

PHI: Protected Health Information

PI: Principal Investigator

PM: Project Manager

PMA: Pre-Market Approval

PMS: Post Marketing Surveillance

QA: Quality Assurance

RDE: Remote Data Entry

SAE: Serious Adverse Event

SC: Study Coordinator

SI: Sub-Investigator

SMO: Site Management Organization

SoCRA: Society of Clinical Research Associates

SOP: Standard Operating Procedure

SR: Significant Risk

Sub-I: Sub-Investigator

UAP: Unanticipated Problem

VAI: Voluntary Action Indicated