In addition to the documents noted elsewhere in this manual, the following documents require IRB review and must be uploaded in the ARROW application:

• Study instruments, including:
  • Questionnaires
    • If using REDCap for surveys, it is strongly encouraged that the Google reCAPTCHA feature is enabled (to aid in data quality and prevent automated submissions)
  • Interview questions
  • Assessments specific to the study
  • Investigator’s Drug Brochures
  • Device specifications
• Communications to subjects that:
  • Disclose the study condition/treatment/arm to which they were assigned when a study has been unblinded
  • Describe new information about study progress or study procedures

Depending on the study, the IRB may request additional documents required to make regulatory determinations.