You learned about the many Essential Documents required to be complete and accurate through the
initiation, conduct and culmination of a clinical trial. Some forms must always be current, and are what
we refer to as "dynamic", or "living", whereas other forms only need to be updated on an annual basis.
From your reading, select all of the forms/documents that should be 'dynamic' to reflect site activities.
(examples of activities could include, but not limited to: screening/enrollment status, site personnel,
investigational product accountability status).
☐ Form FDA 1572
☐ Study Subject/Chart Master List
☐ IRB roster
☐ Adverse Event Log/Listing
☐ Inital IRB Approval Letter
☐ Site Training Verfication Master List
☐ Example of case report forms
☐ Investigator Brouchure
☐ Enrollment log
