Kurze Liste der am häufigsten verwendeten Akronyme in Clinical Research

700U Statement of Economic Interest

ACRP Association of Clinical Research Professionals

AE Adverse Event

ADR Adverse Drug Reaction

AMA American Medical Association

BID Twice Daily

BIND BiologicalIND

CAP Collegeof American Pathologists

CBCTN Community Based Clinical Trials Network

CBER Centerfor Biologics Evaluation and Research (FDA)

CCRA Certified Clinical Research Associate (ACRP)

CCRC Certified Clinical Research Coordinator (ACRP)

CCRC CTSC ClinicalResearchCenter

CCRP Certified Clinical Research Professional (SoCRA)

CDA Confidential Disclosure Agreement

CDC Centerfor Disease Control

CDER Centerfor Drug Evaluation and Research (FDA)

CDRH Centerfor Devices and Radiological Health (FDA)

CF Consent Form

CFR Code of Federal Regulations

CLIA Clinical Laboratory Improvement Amendments

CME Continuing Medical Education

CP Compliance Program (FDA)

COI Conflict of Interest

CRA Clinical Research Associate CTSC Clinical Research Training Program

CRC Clinical Research Coordinator

CRF Case Report Form

CRO Clinical Research Organization

CT Clinical Trial

CTA Clinical Trial Agreement

CS Clinically Significant

CSA Clinical Service Agreement

CTSC Clinical and TranslationalScienceCenter

CV Curriculum Vitae

DCF Data Correction Form / Data Clarification Form

DEA Drug Enforcement Agency (law enforcement division of FDA)

DHHS Department of Health & Human Services

DOS Description of Study

EAB Ethical Advisory Board (similar to IRB, used by other nations)

EDC Electronic Data Capture

FDA Food and Drug Administration

FDA-482 Notice of Inspection

FDA-483 Notice of Adverse Findings in an Inspection

FDA-1572 FDA Form for New Drug Application

FDA-1572 FDA Form for Statement of Investigator

FDA-SRS Spontaneous Reporting System of the FDA

FDCA Food, Droge, and Cosmetic Act

FOIA Freedom of Information Act

FTC Federal Trade Commission

GCP Good Clinical Practice

GDA Global Disclosure Agreement

GLP Good Laboratory Practice CTSC Clinical Research Training Program

 

GMP Good Manufacturing Practice

HIPAA Health Insurance Portability and Accountability Act

HHS Health and Human Services (Department of)

HMO Health Maintenance Organization

IACUC Institutional Animal Care and Use Committee (IRB for animal use)

IB Investigator’s Brochure

 

ICF Informed Consent Form

ICH International Conference on Harmonisation

IDB Investigational Drug Brochure

IDE Investigational Device Exemption

IDS Investigational Drug Service (pharmacy)

INAD Investigational New Animal Drug (FDA)

INDInvestigational New Drug

IRB Institutional Review Board

JCAHO Joint Commission of Accreditation of Health Care Organizations

LOA Letter of Agreement

MDR Medical Device Reporting

MOU Memoranda of Understanding

MRA Medical Research Associate

NAI No Action Indication (most favorable post-FDA inspection classification)

NCI National Cancer Institute

NCS Not Clinically Significant

NDA New Drug Application

NHLBI National Heart, Lunge, and Blood Institute

NIAID National Institute of Allergy and Infectious Diseases CTSC Clinical Research Training Program

 

NIH National Institutes of Health

NIMH National Institute of Mental Health

NKA No Known Allergies

OAI Official Action Indicated (serious post-FDA inspection classification)

OHRP Office for Human Research Protection

OSHA Occupational Safety and Health Administration

OTC Over-the-counter (non-prescription drugs)

OVCR Office of the Vice Chancellor for Research

PCCPoisonControlCenter

PD Pharmacodynamics

PDQ Physician’s Data Query (NCI sponsored cancer trial registry)

PDR Physician’s Desk Reference

PE Physical Examination

PHI Protected Health Information

PI Package Insert

PI Principal Investigator

PK Pharmacokinetics

PLA Product License Application (when seeking commercialization of a biologic)

PMA Pre-Market Approval (when seeking commercialization of a device)

POBy Mouth

PPE Personal Protective Equipment

PPI Patient Package Inserts

PPO Preferred Provider Organization

PRN As Needed

QA Quality Assurance

QC Quality Control

QD Every day CTSC Clinical Research Training Program

 

QID Four Times a Day

QOL Quality of Life

R&D Research and Development

RDE Remote Data Entry

RL Regulatory Letter (post-FDA audit letter)

Rx. Prescription

SAE Serious Adverse Event

SC Study Coordinator

SD Source Document

SMO Site Management Organization

SoCRA Society of Clinical Research Associates

SOMSchoolof Medicine

SOP Standard Operating Procedure

SRA Staff Research Associate

TID Three Times a Day

UNK Unknown

USPU.S.Pharmacopeia

VAUnited StatesDepartment of Veterans Affairs

VAI Voluntary Action Indicated (post-FDA audit inspection classification)

VS Vital Signs

WHO Weltgesundheitsorganisation

WL Warning Letter

Kategorien: Stammzellen-Therapie

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Stammzellen Therapie