INSTRUCTIONS FOR RESPONSE
Please respond to this letter by doing the following:
1.
The
Response to Review document is located on the forms tab. Please
provide your COMPLETE answer to the question in this form in a different font. Please
also state the page number and document
2. Incorporate into the Protocol Summary and any other relevant study documents the changes outlined in this memo as well as any other changes made to address the Committee's questions and concerns about the study. Please submit clean and marked up copies of the revised document(s). This will facilitate the review of your response. Revising documents ensures that the study is conducted according to the updated Protocol and will facilitate continuing review.