GCP Good Clinical Practice ICF Informed consent form ICH International Conference on Harmonisation IMP Investigational medicinal product IRB Institutional review board IRR Infusion-related reaction IV Intravenous IxRS Interactive trial and web response system LDH Lactate dehydrogenase MedDRA Medical Dictionary for Regulatory Activities MTX Methotrexate NCI National Cancer Institute NSAID Nonsteroidal anti-inflammatory drug RA Rheumatoid arthritis RBC Red blood cell RF Rheumatoid factor RTX Rituximab SAE Serious adverse event SBP Systolic blood pressure SIRR Serious infusion-related reaction SIE Serious infection event SSR SUSAR Report SUSAR Suspected unexpected serious adverse reaction TNF Tumor necrosis factor
GCP Good Clinical Practice ICF Informed consent form ICH International Conference on Harmonisation IMP Investigational medicinal product IRB Institutional review board IRR Infusion-related reaction IV Intravenous IxRS Interactive and web response system LDH Lactate dehydrogenase MedDRA Medical Dictionary for Regulatory Activities MTX Methotrexate NCI National Cancer Institute NSAID Nonsteroidal anti-inflammatory drug RA Rheumatoid arthritis RBC Red blood cell RF Rheumatoid factor RTX Rituximab SAE Serious adverse event SBP Systolic blood pressure SIRR Serious infusion-related reaction SIE Serious infection event SSR SUSAR Report SUSAR Suspected unexpected serious adverse reaction TNF Tumor necrosis factor trial
auspar-rituximab-150827-cer.docx