Regulatory Documentation
Before a Clinical Trial can begin, the study’s sponsor must collect regulatory documents from the site Protocol Director. Common regulatory documents include the IRB approval letter, FDA Form 1572, and Financial Disclosure Forms (see Regulatory Binder SOP). The Cancer Clinical Trials Office can provide guidance for investigators completing these documents. The CCTO Clinical Trials Facilitators will also complete new IRB applications and modifications, develop Informed Consent Documents, and complete regulatory binders for Industry, Cooperative Group and Investigator-Initiated studies at request.
Please use the following links for guidance and policies relating to regulatory documentation:
Trial Administration