Typical RESQ Reclamation Activities

RESQ reclamation activities include the following:

  • Assess and resolve, where applicable, trial logistics including: Protocol compliance, CRF design and implementation, investigational product accountability, study equipment, vendor activities, and more.
  • Conduct investigational site monitoring to evaluate and ensure compliance where possible with FDA CFR/ICH/GCP Guidelines, SOPs, and company policies and procedures where applicable, facilitate corrective action.
  • Conduct source verification for routine adverse events, serious adverse events, and IND-safety reports to ensure where possible compliance with FDA CFR/ICH/GCP Guidelines. Where applicable, facilitate corrective action.
  • Conduct quality assessment of essential regulatory documentation. Where applicable, facilitate corrective action to ensure compliance with FDA CFR/ICH/GCP Guidelines.
  • Evaluate investigator’s compliance with IRB reporting requirements and facilitate corrective action, where appropriate.
  • Conduct quality review of informed consent forms and subjects’ informed consent processes. Where applicable, facilitate corrective action to help ensure compliance with FDA CFR/ICH/GCP Guidelines and IRB.