10.0 FORMS TO BE KEPT 
On study forms and all clinical data forms will be recorded into the 
trial data base in the Division of Biostatistics of the Johns Hopkins Oncology 
Center under the direction of its director, Dr. Steven Piantadosi. Forms to 
be kept include: 
10.1 Case Report Forms will be used in this study. They should be 
completed and updated by the principal investigators. Forms include 
eligibility data, history and physical, prior therapy data, concomitant 
medications, vaccine dose administration, extent of disease, notes, course 
assessment, flow sheets, skin toxicity evaluation forms, pharmacokinetics for 
GM-CSF. (Appendix 14.D-14.I). 
10.2 Course Assessment (Follow Up Form) will be completed at the end of 
all treatment courses (Appendix 14.1). The physician will use this form to 
formally grade drug toxicities following each course according to the NCI 
Common Toxicity Criteria (Appendices 14. E and 14. F). 
IN ADDITION TO COURSE ASSESSMENT FORMS, ALL PHYSICIANS WILL BE REQUIRED TO 
WRITE AN ENTRY IN THE PHYSICIANS NOTES SECTION OF THE CASE REPORT FORM AT THE 
END OF EACH COURSE. THIS ENTRY SHOULD SPECIFY: 
10. 2. a. Hospitalization (if any); Length of Hospitalization 
10. 2. b. The Number of Febrile Days 
10. 2. c. Local Wound Care Needs (if any) 
10.3 Trial Data Submission - Data is collected and transmitted daily by 
the Oncology Center Biostatistics Data Manager. This data will be put into 
the computerized trial data base for immediate access and evaluation of 
outcomes. Information will also be transmitted to Somatix Therapy Corporation 
through its clinical trial monitor, and the NIH RAC aand FDA through protocol 
reports per regulations set for human gene therapy clinical trials. The 
results of this study will be presented to national scientific and medical 
meetings on a timely basis. 
Recombinant DNA Research, Volume 17 
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