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Principal Investigator oversight

Our PI can demonstrate effective oversight to the many study related activities being undertaken. This is primarily achieved through ongoing communication with our Sub-Investigators and exercised through our Research Nurses who regularly visit the GP practices. Several additional procedures involve:

  • Ad hoc meetings with research nurses to discuss individual patients
  • Ad hoc telephone calls with Sub-Investigators to discuss individual patients
  • Periodic visits to sub-Investigator sites by the PI and/or clinical development manager
  • Centralised monitoring of laboratory and other study results
  • Centralised reporting and monitoring of SAEs
  • GCP training of sub-Investigators and CPS Research staff
  • Use of a Trial Associated Medical Record (TAMR)
  • Regular management meetings
  • Study-specific training sub-investigators and research nurses
  • ISO 9001:2008 internal audits
  • Green light control procedures