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CCRP Abbreviations &
| Question | Answer |
|---|---|
| ADE | adverse drug event |
| ADR | adverse drug reaction |
| AE | adverse event |
| AERS | adverse event reporting system |
| ALCOA | attributable, legible, contemporaneous, original, accurate |
| BIMO | bioresearch monitoring program |
| CAPA | corrective action preventative action |
| CBER | Center for Biologics Evaluation + Research |
| CCRP | certified clinical research professional |
| CDER | Center for Drugs Evaluation + Research |
| CDRH | Center for Devices and Radiological Health |
| CFR | Code of Federal Regulations |
| CRA | Clinical Research Associate |
| CRC | Clinical Research Coordinator |
| CRF | case report form |
| CRO | contract research organization |
| CTA | clinical trial agreement |
| CTCAE | common terminology criteria for adverse events |
| CTMS | clinical trial management system |
| CV | curriculum vitae |
| DHHS | Department of Health and Human Services |
| DOD | Department of Defense |
| DLT | doses limiting toxicities |
| DSMB | Data Safety Monitoring Board |
| FDA | The Food and Drug Administration |
| FWA | Federal-wide assurance |
| GCP | good clinical practice |
| GMP | good manufacturing practice |
| HIPAA | Health insurance portability and accountability act |
| HSP | human subject protection |
| IB | Investigator's Brochure |
| ICF | informed consent form |
| ICH | International Conference on Harmonization |
| IDE | Investigational Drug Exemption |
| IEC | Institutional Ethics Committee |
| IND | Investigational New Drug (Application) |
| IRB | Institutional Review Board |
| IM | intramuscular |
| IP | Investigational Product |
| IV | intravenous |
| MDR | manufacturing data report/medical doctor research |
| MTD | maximum tolerated dose |
| NCI | National Cancer Institute |
| NIH | National Institute of Health |
| NDA | New Drug Application |
| NSR | non-significant risk |
| OAI | official action indicated |
| OHRP | Office of Human Research and Protection |
| PD | protocol devation/pharmacodynamic |
| PI | Principal Investigator |
| PK | pharmacokinetic |
| PMA | premarket approval |
| PMS | post marketing study |
| QA | Quality Assurance |
| QC | Quality Control |
| RCT | randomized clinical trial |
| SADR | serious adverse drug reaction |
| SAE | serious adverse event |
| SC | study coordinator |
| SD | source document/study drug |
| SDV | source data verification |
| SMO | site management organization |
| SOP | Standard Operating Procedures |
| SR | significant risk |
| SoCRA | the Society of Clinical Research Associates |
| WHO | World Health Organization |
| WL | warning letter |
| WMA | World Medical Association |
| RBM | risk-based monitoring |
| TMF | trial master file |
Created by:
ashleysblair