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QUESTSR
Site Management
  • Site specific Standard Operating Procedures (SOP's)
  • Site initiation and trial close-out operations
  • Submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval
  • Patient Counseling
  • Patient Recruitment
  • Patient Follow-up
  • Trial-related documents archival and maintenance
  • Reporting serious adverse events to the CRO and the IRB/IEC
  • Ensuring protocol compliance
  • Advising & alerting investigators of potential protocol violations
  • Advising & alerting investigators of potential ICH-GCP violations
  • Quality Assurance
  • Audit Services
  • FDA inspection preparation
 
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