Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
current Federal regulations. 
* Patient progress will be reported to the Food and Drug Administration at two- 
month intervals and to the Institutional Review Board after the first five 
patients have been transplanted. 
6.3.4 CLINICAL RESEARCH MONITOR 
A Clinical Research Monitor designated by Baxter Healthcare Corporation, 
Immunotherapy Division, will be responsible for monitoring the clinical study in 
accordance with current Federal regulations. 
The Monitor will visit the investigators on a regular basis to assess compliance with the 
study protocol and overall study objectives until the study is deemed to be completed. 
6.3.5 PATIENTS 
Patients will be selected by the clinical investigators in accordance with the selection 
criteria and guidelines set out in Section 6.1.4. 
All patients meeting the criteria set forth in the protocol will be offered the opportunity 
to participate in the study. No selectivity will be exercised by the investigator in this 
regard so that no bias is introduced from this source. Candidate patients and/or their 
legal guardians will receive a comprehensive explanation of the proposed treatment 
including the nature of the therapy, alternate therapies, any known previously exper- 
ienced adverse reactions, the investigational status of the device, and the other factors 
which are part of obtaining a proper informed consent. All patients or their legal 
guardians must sign an informed consent form before entering the study. 
Recombinant DNA Research, Volume 16 
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