NeuroSAFE PROOF

Resources for Sites

Trial Documents

Please contact [email protected] for access to these documents

Patient Facing Documents

Consent forms, Questionnaires & Health Economics Diaries

  • IIEF-15 Questionnaires
  • EQ-5D-5L Questionnaires
  • ICIQ Questionnaires
  • RAND-36 Questionnaires
  • NeuroSAFE consent form
  • NeuroSAFE patient information sheet

Protocol & Trial Documents

Latest Protocol, IRAS form, TMG minutes & other Investigator Site File Documents

  • NeuroSAFE protocol version 3.0
  • IRAS form
  • TMG minutes
  • REC & HRA approval letters
  • GP letters
  • Significant Findings letters
  • MRI proforma
  • Pathology SOP

Randomisation & Database Documents

Sealed Envelope and TrialSense Account Request Forms & userguides

  • Sealed Envelope Request Forms
  • TrialSense Request Forms
  • Sealed Envelope Userguide
  • TrialSense Userguide
  • Database FAQs
  • Emergency Randomisation procedures