Management Center : Phase I : Investigational New Device
Title
Protocol I.D. Please include as many as are known
Rationale A brief explanation of why the study is being completed
Protocol Objectives Goals of the study
Outline A brief description of the treatment plan. This should include what drugs or therapy the patient will receive and at what times
Protocol Entry Criteria/Patient Eligibility The disease characteristics that a person must have to be enrolled in a particular trial
Prior/Concurrent Therapy Any therapies that would exclude a person from this trial
Patient Characteristics/ Inclusion Criteria Age, sex, performance status, etc
Projected Accrual The number of patients expected to be entered on the trial before it closes to accrual
Study Activation Date The date when patients are allowed to be entered on the trial
Name and complete address information for the protocol chairperson
Name and complete address information for the protocol update person