Study Conduct

  • ensure properly executed informed consent before commencing study procedures or activities
  • develop and implement an appointment reminder system as well as visit scheduling, window, and tracking system.
  • complete all required source document and CRF data fields.
  • perform subject interviews and assessments at study visits as required by protocol.
  • complete progress notes for each subject visit or encounter.
  • document written and verbal communication with study contacts (e.g., subject, sponsor, laboratory).
  • track all laboratory results and schedule follow-up re-testing when as required
  • monitor, record, and respond to all AEs and SAEs according to protocol and report to sponsor.
  • review and file all safety reports
  • record and document protocol deviations.
  • assess and ensure subject safety throughout participation on trial.
  • address all queries and clarifications in a timely manner and ensure that all queries are resolved before a monitoring visit.
  • incorporate applicable source documents (e.g., surgical reports, pathology reports, medical history) in subject file.
  • request and record ancillary service reports (e.g., x-ray, pathology, EKG, laboratory).
  • obtain and file emergency contact, W-9 tax, and authorization for release of medical information forms from each subject.
  • per choice of subject, notify primary care physician and/or specialist doctors of their participation in the trial and any updates (abnormal laboratory results, change in medications, etc) deemed necessary by the investigator.
  • provide weekly status reports and subject logs to sponsors.
  • maintain regulatory binders.
  • schedule and prepare for CRA monitoring visits.