What does the Clinical Research Administration office need to prepare a new submission?
The most important items are the final protocol and a telephone number or email address of the sponsor contact. Essentially, provide the Clinical Research Administration office with all documents (except the case report forms). Other items that are needed are a copy of the cover letter received from the sponsor, a copy of the draft consent and/or the consent form on disk, 1572 information, Financial Disclosure Forms, Protocol signature pages etc.
