Submission Letter (PDF) (DOCX)

Site Questionnaire - One per site. (PDF) (DOCX)

Indemnification Agreement (PDF) (DOCX)

Protocol - Including all attachments, questionnaires, diaries

Informed Consent Form(s)

Photographic Consent Form If applicable

Advertisements Print, TV, radio, internet, billboards, etc.

CVs Principal Investigator and other involved personnel

SAE Report (PDF) (DOCX)

Study Status Report (PDF) (DOCX)

Study Closure Report (PDF) (DOCX)

What is a Protocol? (PDF) (DOCX)

Sample Informed Consent Form (PDF) (DOCX)

Sample Photographic Consent Form (PDF) (DOCX)

Sample Assent Form - Older Children (PDF) (DOCX)

Sample Assent Form - Younger Children (PDF) (DOCX)

Standard Operating Procedures (PDF) (DOCX)

Request for a Partial Waiver (PDF) (DOCX)

Request for a Full Waiver (PDF) (DOCX)