Required For Submission
Submission Letter (PDF) (DOC)
Site Questionnaire - one per site (PDF) (DOC)
Indemnification Agreement (PDF) (DOC)
Protocol - including all attachments, questionnaires, diaries
Informed Consent Form(s)
Photographic Consent Form - if applicable
Advertisements - print, TV, radio, internet, billboards, etc.
CVs of Principal Investigator and other involved personnel

Reporting Forms
SAE Report (PDF) (DOC)
Study Status Report (PDF) (DOC)
Study Closure Report (PDF) (DOC)

Sample Forms Examples
What is a Protocol? (PDF) (DOC)
Sample Informed Consent Form (PDF) (DOC)
Sample Photographic Consent Form (PDF) (DOC)
Sample Assent Form - Older Children (PDF) (DOC)
Sample Assent Form - Younger Children (PDF) (DOC)

Procedures
Standard Operating Procedures (PDF) (DOC)

HIPAA
Request for a Partial Waiver (PDF) (DOC)
Request for a Full Waiver (PDF) (DOC)