Check boxes where an action is to be taken. If clinical response is an endpoint, specify what constitutes a complete response, a partial response, stable disease and progressive disease. For quality of life and other questionnaires, provide copies in the appendix. References to validation studies for these instruments are also appropriate. If appropriate, describe how many patients will be studied, at what times samples are to be drawn.
Toxicities Review the major toxicities of each treatment component.
Overall survival, Clinical response. This section is traditional at UCSF, but most of the information should appear in the consent form. You may want to use it to anticipate possible problems, e.g. that a contingency fund exists to defray the cost of an expensive test for patients whose insurers will not cover the procedure, or exceptional procedures that will be used to protect privacy in particularly sensitive cases. If used, include details about any reimbursement for participation in the study, who plays for evaluation and treatments, what provisions are made for addressing treatment-related injuries. Loss of confidentiality and privacy issues should also be addressed.