Forms And Instructions

1) New Submission Information and Application Forms

   a) Application Instructions (doc)

   b) Application Cover/Signature Page (doc)

   c) Application for Use of Human Subjects (doc)

   d) Elements of a Protocol (doc)

2) Informed Consent Requirements and Forms

   e) Consent Form Formatting & Other Requirements (doc)

   f) Elements of Informed Consent (doc)

   g) Informed Consent Template (doc)

   h) Spanish Informed Consent Template (doc)

   i) Minor Assent Form (doc)

   j) Parent Permission/Child Assent Template (doc)

   k) Statement of Witness for Consent of Subjects Unable to Read (doc)

   l) Waiver of Documentation of Informed Consent (doc)

   m) Waiver of Informed Consent (doc)

3) Forms and Guidance Used During the Life of a Study

   n) Amendment Application (doc)

   o) Guidance on Reporting Unanticipated Problems (doc)

   p) Report of Unanticipated Problem (Including Serious Adverse Events) (doc)

   q) Report of Protocol Violation/Deviation (doc)

   r) Continuing Review Progress Report (doc)

   s) Exempt Research Status Report (doc)

   t) Final Protocol Closure Report (doc)