Commonly Used Abbreviations and Terms in ... - NC TraCS Institute [PDF]

COMMONLY USED ABBREVIATIONS AND TERMS in CLINCAL TRIALS Abbreviation ADR AE AUC BLA BUN CAP CBER CDER CDRH CFR CI CLIA Cmax Cmin CNT Cr CRA CRC CRF CRO CT CTA CTC CTCAE CYP DAR DHEA DLT DNA DSMB DSMP

Definition Adverse Drug Reaction Adverse Event Area Under the Curve Biologic Licensing Application Blood Urea Nitrogen College of American Pathologists Center for Biologics Evaluation and Research (FDA) Center for Drug Evaluation and Research (FDA) Center for Devices and Radiological Health (FDA) Code of Federal Regulations Confidence Interval Clinical Laboratory Improvements Amendments Maximum Plasma Concentration Minimum Plasma Concentration Consented but Not Treated Serum Creatinine Clinical Research Associate Clinical Research Coordinator Case Report Form Contract Research Organization Computed Tomography Clinical Trials Agreement Circulating Tumor Cell Count Common Terminology Criteria for Adverse Events Cytochrome P450 Drug or Device Accountability Records Dihydroepiandrosterone Dose Limiting Toxicity Deoxyribonucleic Acid Data Safety Monitoring Board Data Safety Monitoring Plan

EC

Ethics Committee

ECG ECOG

Electrocardiogram Eastern Cooperative Oncology Group (Used to determine Performance Status ) Electronic Data Capture European Agency for the Evaluation of Medicinal Products Food and Drug Administration Federal Wide Assurance number (number assigned to IRB ) Good Clinical Practices Good Laboratory Practices Good Manufacturing Practices Health Assessment Questionnaire Humanitarian Device Exemption (must be in place to use a HUD) Humanitarian Use Device (for less than 4, 000 subjects) Investigator’s Brochure Informed Consent Form International Conference on Harmonization Inhibitory Concentration 50% Investigational Device Exemption Independent Ethics Committee Investigational New Drug Institutional Review Board Injection Site Reaction Intent-to-Treat Interactive Voice Recognition System Inhibition Constant Lactate Dehydrogenase Medical Device Reporting Medical Dictionary for Regulatory Activities Millimeters of Mercury Medical Outcomes Study Maximum Tolerated Dose New Drug Application

EDC EMEA FDA FWA number GCP GLP GMP HAQ HDE HUD IB ICF ICH IC50 IDE IEC IND IRB ISR ITT IVRS Ki LDH MDR MedDRA mmHg MOS MTD NDA

NSR

Tbili TK t1/2 TTP WBC WHO

Non-Significant Risk ( usually refers to device research ) Office for Human Research Protection Pharmacodynamics Progression-Free Survival Principal Investigator Pharmacokinetic Pre- Market Approval Post Marketing Surveillance As Needed Quality of Life QT Interval Corrected by the Fridericia Correction Formula Response Evaluation Criteria in Solid Tumors (Oncology ) Serious Adverse Event Standard Deviation Source Document Verification Standard Error for the Mean Site Evaluation Visit Site Initiation Visit Significant Risk (usually refers to device research) Total Bilirubin Toxicokinetics Half-Life Time To Progression White Blood Cell Count World Health Organization

WMA

World Medical Association

OHRP PD PFS PI PK PMA PMS prn QOL QTcF RECIST SAE SD SDV SEM SEV SIV SR