Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
6.3.2 CASE REPORT FORMS 
All of the information pertinent to the necessary observations and tests (as outlined in 
Section 6.1.6 through 6.1.8) will be logged on the case report forms provided by the 
sponsor. All forms must be signed and dated by the investigator upon completion, 
reviewed for completeness and accuracy (according to the protocol), and forwarded to 
Immunotherapy Division, Santa Ana, California. They will be reviewed by the Clinical 
Monitor for completeness and accuracy. The investigator will retain a copy of each form 
in his file for a period of not less than two years after submission of experimental data 
to the Food and Drug Administration (as required by Federal regulations). In addition, 
the clinical investigator will keep a master file which lists all patients participating in the 
study. 
6.3.3 SPONSOR 
The sponsor of the study is Baxter Healthcare Corporation, Biotech Group, 1710 Flower 
Avenue, Duarte, CA 91010. The sponsor will: 
* Select the clinical investigators to participate in the study in a manner which 
is consistent with Federal regulations. 
* Provide the clinical investigators performing the studies with all investigational 
device components and report forms. 
* Keep the "Investigational Product Inventory" and "Case Report Log". 
* Maintain a record of all original case report forms with provision for 
preserving patient confidentiality. 
* Ensure that the clinical investigators will be monitored in accordance with 
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