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SAE Reporting and Safety/Pharmacovigilance
The DMID-CROMS Pharmacovigilance team (PVG) is responsible for the collection, assessment and reporting of safety information to regulatory authorities and investigators worldwide.
Timely reporting of Serious Adverse Events (SAEs) is necessary for the protection of clinical trial subjects and for rapid dissemination of significant new findings related to the safety of investigational drugs.
The PVG team works closely with OCRA Safety to ensure that all systems and procedures meet FDA regulations, the European Union Clinical Trial Directive and any other applicable regulatory authority guidelines relating to processing and reporting of SAEs.
The PVG team receives adverse events reported by sites participating in DMID-supported studies, processes the events for review by the DMID Medical Officer, and prepares the reports for submission to the Food and Drug Administration (FDA).
All Investigators are instructed to submit SAEs to PVG via fax or email. Investigators have access to a 24/7 SAE Hotline which is available for real-time assistance with SAE reporting. Please refer to the following contact information:
A Serious Adverse Event is one that meets one or more of the following criteria:
  • Results in death
  • Is immediately life threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Is a congenital anomaly/birth defect
  • Is an important medical event
Forms and Guidelines

 Current forms

 
  
DocumentTitle
Safety Pharmacovigilance Fact Sheet.docx
Site Fax Cover to PVG.docx

 Revised forms

 
  
DocumentTitle
SAE Form Guidelines v 3.0.pdf
SAE Form v 3.0.docx
Site SAE Fax Cover Page v 2.0.pdf