Informed Consent Process

  • develop ICF quality assurance SOP and source document to be used with each subject to ensure that all initials and signatures are obtained, proper dating recorded, time of ICF execution noted, subject’s ICF copy provided, discussion and process documented, and GCP and HIPAA compliance are maintained.
  • conduct informed consent:
    • explain study to subjects (e.g. purpose, duration, risks, benefits, expectations, alternatives, etc.);
    • obtain all required signatures and initials with proper dating;
    • allow for sufficient time for review in a private setting, time for consideration and consultation with physician and/or family members, and time for questions
    • document informed consent process in source documentation, progress notes, and in ICF log;
    • re-consent subjects as needed
    • ensure full execution of ICF or ICF revision prior to commencement of study procedures