How do I know if I need to submit additional documents in addition to the SIQ?

The SIQ instructions will alert you if any of the following elements are needed.

  • “Site Information Questionnaire: Additional Research Facility” form
  • Proposed site-specific advertisements and recruitment materials. These materials should be accompanied by written sponsor approval if this is required by the sponsor
  • Proposed site-specific participant study materials (diaries, questionnaires, written study instructions, etc.)
  • Supplemental material as appropriate based on “Site Information Questionnaire” responses (for example, FDA Audit information, letters of explanation, etc.)